MARKETING by: PIYUSH TRIPATHI
Marketing is communications-based process through which individuals and communities are informed or persuaded that existing and newly-identified needs and wants may be satisfied by the products and services of others.
Marketing is used to create the customer, to keep the customer and to satisfy the customer. With the customer as the focus of its activities, it can be concluded that Marketing is one of the premier components of Business Management - the other being Operations (or Production). Other services and management activities such as Human Resources, Accounting, Law and Legal aspects can be "bought in" or "contracted out".
Marketing is defined by the American Marketing Association as the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large. The term developed from the original meaning which referred literally to going to a market to buy or sell goods or services.
The Chartered Institute of Marketing defines marketing as "The management process responsible for identifying, anticipating and satisfying customer requirements profitably.
Marketing practice tended to be seen as a creative industry in the past, which included advertising, distribution and selling. However, because the academic study of marketing makes extensive use of social sciences, psychology, sociology, mathematics, economics, anthropology and neuroscience, the profession is now widely recognized as a science, allowing numerous universities to offer Master-of-Science (MSc) programmers. The overall process starts with marketing research and goes through market segmentation, business planning and execution, ending with pre and post-sales promotional activities. It is also related to many of the creative arts. The marketing literature is also adept at re-inventing itself and its vocabulary according to the times and the culture.
Seen from a systems point of view, sales process engineering views marketing as a set of processes that are interconnected and interdependent with other functions, whose methods can be improved using a variety of relatively new approaches.
CONTENTS
1 The marketing concept
2 Marketing orientations
2.1 Product orientation
2.2 Sales orientation
2.3 Production orientation
2.4 Marketing orientation
2.4.1 Customer orientation
2.4.2 Organizational orientation
2.4.3 Mutually beneficial exchange
3 The Four Ps
4 The marketing environment
4.1 The macro-environment
4.2 The micro-environment
5 Marketing research
6 Product
6.1 Branding
7 Marketing communications
7.1 Personal sales
7.2 Sales promotion
7.3 Public Relations
7.4 Publicity
7.5 Advertising
7.6 Marketing communications "mix"
8 Marketing Planning
8.1 Marketing Planning Process
8.2 Marketing objectives within an organization
8.2.1 Corporate level
8.2.2 SBU level
8.2.3 Functional level
The marketing concept
The term marketing concept pertains to the fundamental premise of modern marketing. This concept proposes that in order to satisfy its organizational objectives, an organization should anticipate the needs and wants of consumers and satisfy these more effectively than competitors.
Marketing orientations
An orientation, in the marketing context, relates to a perception or attitude a firm holds towards its product or service, essentially concerning consumers and end-users. There exist several common orientations:
Product orientation
A firm employing a product orientation is chiefly concerned with the quality of its own product. A firm would also assume that as long as its product was of a high standard, people would buy and consume the product.
This works most effectively when the firm has good insights about customers and their needs and desires, as for example in the case of Sony Walkman or Apple iPod, whether these derive from intuitions or research.
Sales orientation
A firm using a sales orientation focuses primarily on the selling/promotion of a particular product, and not determining new consumer desires as such. Consequently, this entails simply selling an already existing product, and using promotion techniques to attain the highest sales possible.
Such an orientation may suit scenarios in which a firm holds dead stock, or otherwise sells a product that is in high demand, with little likelihood of changes in consumer tastes diminishing demand.
Production orientation
A firm focusing on a production orientation specializes in producing as much as possible of a given product or service. Thus, this signifies a firm exploiting economies of scale, until the minimum efficient scale is reached.
A production orientation may be deployed when a high demand for a product or service exists, coupled with a good certainty that consumer tastes do not rapidly alter (similar to the sales orientation).
Marketing orientation
The marketing orientation is perhaps the most common orientation used in contemporary marketing. It involves a firm essentially basing its marketing plans around the marketing concept, and thus supplying products to suit new consumer tastes.
As an example, a firm would employ market research to gauge consumer desires, use R&D to develop a product attuned to the revealed information, and then utilize promotion techniques to ensure persons know the product exists. The marketing orientation often has three prime facets, which are:
Customer orientation
A firm in the market economy survives by producing goods that persons are willing and able to buy. Consequently, ascertaining consumer demand is vital for a firm's future viability and even existence as a going concern.
Organizational orientation
All departments of a firm should be geared to satisfying consumer wants/needs. In this sense, a firm's marketing department is often seen as of prime importance within the functional level of an organization.
Information from an organization's marketing department would be used to guide the actions of other department's within the firm. As an example, a marketing department could ascertain (via marketing research) that consumers desired a new type of product, or a new usage for an existing product. With this in mind, the marketing department would inform the R&D department to create a prototype of a product/service based on consumers' new desires.
The production department would then start to manufacture the product, while the marketing department would focus on the promotion, distribution, pricing, etc. of the product. Additionally, a firm's finance department would be consulted, with respect to securing appropriate funding for the development, production and promotion of the product.
Inter-departmental conflicts may occur, should a firm adhere to the marketing orientation. Production may oppose the installation, support and servicing of new capital stock, which may be needed to manufacture a new product. Finance may oppose the required capital expenditure, since it could undermine a healthy cash flow for the organization.
Mutually beneficial exchange
In a transaction in the market economy, a firm gains revenue, which thus leads to more profits/market share/sales. A consumer on the other hand gains the satisfaction of a need/want, utility, reliability and value for money from the purchase of a product or service. As no one has to buy goods from any one supplier in the market economy, firms must entice consumers to buy goods with contemporary marketing ideals.
The Four Ps
Main article: Marketing mix
In the early 1960s, Professor Neil Borden at Harvard Business School identified a number of company performance actions that can influence the consumer decision to purchase goods or services. Borden suggested that all those actions of the company represented a “Marketing Mix”. Professor E. Jerome McCarthy, at the Michigan State University in the early 1960s, suggested that the Marketing Mix contained 4 elements: product, price, place and promotion.
Product: The product aspects of marketing deal with the specifications of the actual goods or services, and how it relates to the end-user's needs and wants. The scope of a product generally includes supporting elements such as warranties, guarantees, and support.
Pricing: This refers to the process of setting a price for a product, including discounts. The price need not be monetary; it can simply be what is exchanged for the product or services, e.g. time, energy, or attention. Methods of setting prices optimally are in the domain of pricing science.
Placement (or distribution): refers to how the product gets to the customer; for example, point-of-sale placement or retailing. This third P has also sometimes been called Place, referring to the channel by which a product or service is sold (e.g. online vs. retail), which geographic region or industry, to which segment (young adults, families, business people), etc. also referring to how the environment in which the product is sold in can affect sales.
Promotion: This includes advertising, sales promotion, including promotional education, publicity, and personal selling. Branding refers to the various methods of promoting the product, brand, or company.
These four elements are often referred to as the marketing mix,[4] which a marketer can use to craft a marketing plan.
The four Ps model is most useful when marketing low value consumer products. Industrial products, services, high value consumer products require adjustments to this model. Services marketing must account for the unique nature of services.
Industrial or B2B marketing must account for the long term contractual agreements that are typical in supply chain transactions. Relationship marketing attempts to do this by looking at marketing from a long term relationship perspective rather than individual transactions.
As a counter to this, Morgan, in Riding the Waves of Change (Jossey-Bass, 1988), suggests that one of the greatest limitations of the 4 Ps approach "is that it unconsciously emphasizes the inside–out view (looking from the company outwards), whereas the essence of marketing should be the outside–in approach".
In order to recognize the different aspects of selling services, as opposed to Products, a further three Ps were added to make a range of Seven Ps for service industries:
Process - the way in which orders are handled and customers satisfied
Physical Evidence - what customers can see of the selling surroundings- the shop style, the buying experience
People - the people meeting and dealing with the customers.
As markets have become more satisfied, the 7 Ps have become relevant to those companies selling products, as well as those solely involved with services: customers now differentiate between sellers of goods by the service they receive in the process from the people involved.
Some authors cite a further P - Packaging - this is thought by many to be part of Product, but in certain markets (Japan, China for example) and with certain products (perfume, cosmetics) the packaging of a product has a greater importance - maybe even than the product itself.
The marketing environment
The term "marketing environment" relates to all of the factors (whether internal, external, direct or indirect) that affect a firm's marketing decision-making/planning. A firm's marketing environment consists of three main areas, which are:
The macro-environment, over which a firm holds little control
The micro-environment, over which a firm holds a greater amount (though not necessarily total) control
The internal environment
The macro-environment
A firm's marketing macro-environment consists of a variety of external factors that manifest on a large (or macro) scale. These are typically economic, social, political or technological phenomena. A common method of assessing a firm's macro-environment is via a PESTLE (Political, Economic, Social, Technological, Legal, Ecological) analysis. Within a PESTLE analysis, a firm would analyse national political issues, culture and climate, key macroeconomic conditions, health and indicators (such as economic growth, inflation, unemployment, etc.), social trends/attitudes, and the nature of technology's impact on its society and the business processes within the society.
The micro-environment
A firm's micro-environment comprises factors pertinent to the firm itself, or stakeholders closely connected with the firm or company.
A firm's micro-environment typically spans:
Customers/consumers
Employees
Suppliers
By contrast to the macro-environment, an organization holds a greater degree of control over these factors. these all factors a firm can handle/ control by using the marketing tools
Marketing research
Marketing research involves conducting research to support marketing activities, and the statistical interpretation of data into information. This information is then used by managers to plan marketing activities, gauge the nature of a firm's marketing environment, attain information from suppliers, etc.
A distinction should be made between marketing research and market research. Market research pertains to research in a given market. As an example, a firm may conduct research in a target market, after selecting a suitable market segment. In contrast, marketing research relates to all research conducted within marketing. Thus, market research is a subset of marketing research.
Marketing researchers use statistical methods (such as quantitative research, qualitative research, hypothesis tests, Chi-squared tests, linear regression, correlation co-efficients, frequency distributions, Poisson and Binomial distributions, etc.) to interpret their findings and convert data into information.
Product
Main article: New Product Development
Branding
Main article: Brand
A brand is a name, term, design, symbol, or other feature that distinguishes products and services from competitive offerings. A brand is more than a name, design or symbol. Brand reflects personality of the company which is organizational culture.
A brand has also been defined as an identifiable entity that makes a specific value based on promises made and kept either actively or passively.
Branding means creating reference of certain products in mind.
Co-branding involves marketing activity involving two or more products.
Marketing communications
Marketing communications is defined by actions a firm takes to communicate with end-users, consumers and external parties. Marketing communications encompasses four distinct subsets, which are:
Personal sales
Oral presentation given by a salesperson who approaches individuals or a group of potential customers:
Live, interactive relationship
Personal interest
Attention and response
Interesting presentation
Clear and thorough.
Sales promotion
Short-term incentives to encourage buying of products:
Instant appeal
Anxiety to sell
An example is coupons or a sale. People are given an incentive to buy, but this does not build customer loyalty or encourage future repeat buys. A major drawback of sales promotion is that it is easily copied by competition. It cannot be used as a sustainable source of differentiation.
Public Relations
Public Relations (or PR, as an acronym) is the use of media tools by a firm in order to promote goodwill from an organization to a target market segment, or other consumers of a firm's good/service. PR stems from the fact that a firm cannot seek to antagonize or inflame its market base, due to incurring a lessened demand for its good/service. Organizations undertake PR in order to assure consumers, and to forestall negative perceptions towards it.
PR can span:
Interviews
Speeches/Presentations
Corporate literature, such as financial statements, brochures, etc.
Publicity
Publicity involves attaining space in media, without having to pay directly for such coverage. As an example, an organization may have the launch of a new product covered by a newspaper or TV news segment. This benefits the firm in question since it is making consumers aware of its product, without necessarily paying a newspaper or television station to cover the event.
Advertising
Advertising occurs when a firm directly pays a media channel to publicize its product. Common examples of this include TV and radio adverts, billboards, branding, sponsorship, etc.
Marketing communications "mix"
Marketing communications is a "sub-mix" within the Promotion aspect of the marketing mix, as the exact nature of how to apply marketing communications depends on the nature of the product in question.
Accordingly, a given product would require a unique communications mix, in order to convey successfully information to consumers. Some products may require a stronger emphasis on personal sales, while others may need more focus on advertising.
Marketing Planning
The area of marketing planning involves forging a plan for a firm's marketing activities. A marketing plan can also pertain to a specific product, as well as to an organization's overall marketing strategy.
Generally speaking, an organization's marketing planning process is derived from its overall business strategy. Thus, when top management are devising the firm's strategic direction/mission, the intended marketing activities are incorporated into this plan.
Marketing Planning Process
Within the overall strategic marketing plan, the stages of the process are listed as thus:
Mission Statement
Corporate Objectives
Marketing Audit
SWOT analysis
Assumptions arising from the Audit and SWOT analysis
Marketing objectives derived from the assumptions
An estimation of the expected results of the objectives
Identification of alternative plans/mixes
Budgeting for the marketing plan
A first-year implementation programme
Marketing objectives within an organization
As stated previously, the senior management of a firm would formulate a general business strategy for a firm. However, this general business strategy would be interpreted and implemented in different contexts throughout the firm.
Corporate level
Corporate marketing objectives are typically broad-based in nature, and pertain to the general vision of the firm in the short, medium or long-term.
As an example, if one pictures a group of companies (or a conglomerate), top management may state that sales for the group should increase by 25% over a ten year period.
SBU level
SBU, in this case, means strategic business unit. An SBU is a subsidiary within a firm, which participates within a given market/industry. The SBU would embrace the corporate strategy, and attune it to its own particular industry. For instance, an SBU may partake in the sports goods industry. It thus would ascertain how it would attain additional sales of sports goods, in order to satisfy the overall business strategy.
Functional level
The functional level relates to departments within the SBUs, such as marketing, finance, HR, production, etc. The functional level would adopt the SBU's strategy and determine how to accomplish the SBU's own objectives in its market.
To use the example of the sports goods industry again, the marketing department would draw up marketing plans/strategies/communications to help the SBU achieve its marketing aims.
Diversification Planning Product Development- By Piyush Tripathi
Diversification Planning Product Development- By Piyush Tripathi
With the global economics going up at a slower rate market research and studies based on end product and productivity issue for the diversification wing has taken a back seat. As an individual researcher, Ideas to share on the market and new generation product launch with brand building database has come to a new height.
Most commonly heard terms and misunderstood is Diversification. Diversification is a form of corporate strategy for a company. It seeks to increase profitability through greater sales volume obtained from new products and new markets. Diversification can occur either at the business unit level or at the corporate level. At the business unit level, it is most likely to expand into a new segment of an industry which the business is already in. At the corporate level, it is also very interesting entering a promising business outside of the scope of the existing business unit.
Common used product that affects larger volume of individuals is the division where policy and diversification is to be accounted for. We see common day to day products, but share our ideas to non, or rather our ideas are in vain for we don’t know where to collectively put your ideas to make a difference. Source study is most important, its more important to speak at the correct source. With this step and link build up as a researcher, common views are to be highlighted and are to be put up for consideration.
Research on Market Suggestive Developments Industry Specific:
1. Pharmaceutical Industry
Pharmaceutical Industry is the most advanced and improving industry, R & D in Pharma is a constant ask and need. New Drug Delivery Systems are developed and are accounted for. Pharmaceutical industry works on patent and regulatory norms. Common and advanced system recently in development and thought of are as below
- Drug delivery through patches – most common nicotine patch we have heard of but did we ever thought that small kids and people who can not take pills or syrups how can we effectively deliver the medicine to them. Yes the answer is Patches. What form in which drugs these patch can heal is a question. Researches are yet to identify this field as a probable medicines that can be transformed to suit this unique drug delivery system.
- Soluble oral Pills – Better taste common drug, pills in form of chewable drug direct impact specially for cough and cold. Tablets without water like candies best system for kids, easy to carry, and handy easy to target cure.
- Syrup form water or liquid soluble or even soluble tablets. – Required for kids, older people and people with difficulty in swallow. When with sore thought we often complain in gulping with soluble tablets or oral pills drug delivery will be much more easy and cure will be more concentrate.
2. Food Industry
Food Industry is the Largest in the world, every day new products come in market with better packing, attractive offers, this free and an opportunity, all deliver one thing that is taste. The most complex and explored division of industry, understanding Human. The study begins with understanding the product on shelf. Alternate packing and Product launch with success, recent product delivered on shelf, as per our previous study and life cycle examples, were Tomato ketchup in squeeze pack and jams in squeeze pack. What is the market it captured is known to all. Industry is growing day by day, children tooth pastes which can be gulped, is also one product that is really admirable. Now the few new developments pipeline.
- Drinking Powder in Cubes - Most common product that require a change and thought of is dinking powder, i.e. chocolate flavor, banana flavor, strawberry flavor etc. Flavor of milk changes and kid is happy, adults have flavor tea, different verity, and kids have their flavor, but most common problem is to preserve this powder, it gets solidify with wet spoon, hands, some time dip of gentle hands of kids for they want to dig in the product for its flavor, solution is cube of flavor, we buy 3 different boxes of different flavor rather development of a packing which is small, easy to handle and better low cost for soluble cubes for different flavor with a surprise or separate are to be made available.
- Common washing Powder – Cube form of washing powder, washing machine normally of 5.5 kg. or soluble water of 20 ltrs. Washing powder consumption 20-30 gm. For good powders + an additive. If the same product is in cube for 10 ltrs. Of water 1 cube, calculation is easy, preserving the powder is easy large packs storage can be avoided. Product can be easily carried and size of packing reduced due to compressed form.
3. IT Industry
With Cloud computing, and smaller ERP, personalized IT solutions are key focus in today’s life. Business generation from B2B, B2C, Websites, Portals, SEO’S are most common solution from the IT service providers. With the race of web solution provider, promoters, solution and right business source is scare. IT is the core industry on which 60 % of the industries depend on for the promotion of business and research database. Solution from this industry is considered to be user specific and is taken in to account for the results are instant and unbelievable the word world wide web, is truly proving to its meaning connection the entire world with in its web. People are more addicted to be spending time on PC then at home with Family. With hard competition and low margin industry IT solution for smallest of the organization has come to a dream come true project. Many Papers are written on the research in the industry and probable solution. Concentrating more on the need to diversification IT firms compounded the term Cloud Computing. Cloud computing describes computation, software, data access, and storage services that do not require end-user knowledge of the physical location and configuration of the system that delivers the services. Parallels to this concept can be drawn with the electricity grid where end-users consume power resources without any necessary understanding of the component devices in the grid required to provide the service.
Cloud computing is a natural evolution of the widespread adoption of virtualization, service-oriented architecture, autonomic and utility computing. Details are abstracted from end-users, who no longer have need for expertise in, or control over, the technology infrastructure "in the cloud" that supports them.
Identification of the need to developing a system orientation program for small scale industry, Re-defining the cloud concept is essential, service industry B2B market and system configuration, ERP concepts are predefined but are not suitable for the small and medium size firms. Identify the industry and importance of the flow of process orientation programs, tracking system activity base system development. To develop system on Total Cost Management tools like Activity Based Costing (ABC), Activity Based Management (ABM) and Target Costing is required.
We can make a Difference:
Diversification is a form of growth strategy. Growth strategies involve a significant increase in performance objectives (usually sales or market share) beyond past levels of performance. Many organizations pursue one or more types of growth strategies. One of the primary reasons is the view held by many investors and executives that "bigger is better." Growth in sales is often used as a measure of performance. Even if profits remain stable or decline, an increase in sales satisfies many people. The assumption is often made that if sales increase, profits will eventually follow.
Growth may also improve the effectiveness of the organization. Larger companies have a number of advantages over smaller firms operating in more limited markets.
1. Large size or large market share can lead to economies of scale. Marketing or production synergies may result from more efficient use of sales calls, reduced travel time, reduced changeover time, and longer production runs.
2. Learning and experience curve effects may produce lower costs as the firm gains experience in producing and distributing its product or service. Experience and large size may also lead to improved layout, gains in labor efficiency, redesign of products or production processes, or larger and more qualified staff departments (e.g., marketing research or research and development).
3. Lower average unit costs may result from a firm's ability to spread administrative expenses and other overhead costs over a larger unit volume. The more capital intensive a business is, the more important its ability to spread costs across a large volume becomes.
4. Improved linkages with other stages of production can also result from large size. Better links with suppliers may be attained through large orders, which may produce lower costs (quantity discounts), improved delivery, or custom-made products that would be unaffordable for smaller operations. Links with distribution channels may lower costs by better location of warehouses, more efficient advertising, and shipping efficiencies. The size of the organization relative to its customers or suppliers influences its bargaining power and its ability to influence price and services provided.
5. Sharing of information between units of a large firm allows knowledge gained in one business unit to be applied to problems being experienced in another unit. Especially for companies relying heavily on technology, the reduction of R&D costs and the time needed to develop new technology may give larger firms an advantage over smaller, more specialized firms. The more similar the activities are among units, the easier the transfer of information becomes.
6. Taking advantage of geographic differences is possible for large firms. Especially for multinational firms, differences in wage rates, taxes, energy costs, shipping and freight charges, and trade restrictions influence the costs of business. A large firm can sometimes lower its cost of business by placing multiple plants in locations providing the lowest cost. Smaller firms with only one location must operate within the strengths and weaknesses of its single location.
With the global economics going up at a slower rate market research and studies based on end product and productivity issue for the diversification wing has taken a back seat. As an individual researcher, Ideas to share on the market and new generation product launch with brand building database has come to a new height.
Most commonly heard terms and misunderstood is Diversification. Diversification is a form of corporate strategy for a company. It seeks to increase profitability through greater sales volume obtained from new products and new markets. Diversification can occur either at the business unit level or at the corporate level. At the business unit level, it is most likely to expand into a new segment of an industry which the business is already in. At the corporate level, it is also very interesting entering a promising business outside of the scope of the existing business unit.
Common used product that affects larger volume of individuals is the division where policy and diversification is to be accounted for. We see common day to day products, but share our ideas to non, or rather our ideas are in vain for we don’t know where to collectively put your ideas to make a difference. Source study is most important, its more important to speak at the correct source. With this step and link build up as a researcher, common views are to be highlighted and are to be put up for consideration.
Research on Market Suggestive Developments Industry Specific:
1. Pharmaceutical Industry
Pharmaceutical Industry is the most advanced and improving industry, R & D in Pharma is a constant ask and need. New Drug Delivery Systems are developed and are accounted for. Pharmaceutical industry works on patent and regulatory norms. Common and advanced system recently in development and thought of are as below
- Drug delivery through patches – most common nicotine patch we have heard of but did we ever thought that small kids and people who can not take pills or syrups how can we effectively deliver the medicine to them. Yes the answer is Patches. What form in which drugs these patch can heal is a question. Researches are yet to identify this field as a probable medicines that can be transformed to suit this unique drug delivery system.
- Soluble oral Pills – Better taste common drug, pills in form of chewable drug direct impact specially for cough and cold. Tablets without water like candies best system for kids, easy to carry, and handy easy to target cure.
- Syrup form water or liquid soluble or even soluble tablets. – Required for kids, older people and people with difficulty in swallow. When with sore thought we often complain in gulping with soluble tablets or oral pills drug delivery will be much more easy and cure will be more concentrate.
2. Food Industry
Food Industry is the Largest in the world, every day new products come in market with better packing, attractive offers, this free and an opportunity, all deliver one thing that is taste. The most complex and explored division of industry, understanding Human. The study begins with understanding the product on shelf. Alternate packing and Product launch with success, recent product delivered on shelf, as per our previous study and life cycle examples, were Tomato ketchup in squeeze pack and jams in squeeze pack. What is the market it captured is known to all. Industry is growing day by day, children tooth pastes which can be gulped, is also one product that is really admirable. Now the few new developments pipeline.
- Drinking Powder in Cubes - Most common product that require a change and thought of is dinking powder, i.e. chocolate flavor, banana flavor, strawberry flavor etc. Flavor of milk changes and kid is happy, adults have flavor tea, different verity, and kids have their flavor, but most common problem is to preserve this powder, it gets solidify with wet spoon, hands, some time dip of gentle hands of kids for they want to dig in the product for its flavor, solution is cube of flavor, we buy 3 different boxes of different flavor rather development of a packing which is small, easy to handle and better low cost for soluble cubes for different flavor with a surprise or separate are to be made available.
- Common washing Powder – Cube form of washing powder, washing machine normally of 5.5 kg. or soluble water of 20 ltrs. Washing powder consumption 20-30 gm. For good powders + an additive. If the same product is in cube for 10 ltrs. Of water 1 cube, calculation is easy, preserving the powder is easy large packs storage can be avoided. Product can be easily carried and size of packing reduced due to compressed form.
3. IT Industry
With Cloud computing, and smaller ERP, personalized IT solutions are key focus in today’s life. Business generation from B2B, B2C, Websites, Portals, SEO’S are most common solution from the IT service providers. With the race of web solution provider, promoters, solution and right business source is scare. IT is the core industry on which 60 % of the industries depend on for the promotion of business and research database. Solution from this industry is considered to be user specific and is taken in to account for the results are instant and unbelievable the word world wide web, is truly proving to its meaning connection the entire world with in its web. People are more addicted to be spending time on PC then at home with Family. With hard competition and low margin industry IT solution for smallest of the organization has come to a dream come true project. Many Papers are written on the research in the industry and probable solution. Concentrating more on the need to diversification IT firms compounded the term Cloud Computing. Cloud computing describes computation, software, data access, and storage services that do not require end-user knowledge of the physical location and configuration of the system that delivers the services. Parallels to this concept can be drawn with the electricity grid where end-users consume power resources without any necessary understanding of the component devices in the grid required to provide the service.
Cloud computing is a natural evolution of the widespread adoption of virtualization, service-oriented architecture, autonomic and utility computing. Details are abstracted from end-users, who no longer have need for expertise in, or control over, the technology infrastructure "in the cloud" that supports them.
Identification of the need to developing a system orientation program for small scale industry, Re-defining the cloud concept is essential, service industry B2B market and system configuration, ERP concepts are predefined but are not suitable for the small and medium size firms. Identify the industry and importance of the flow of process orientation programs, tracking system activity base system development. To develop system on Total Cost Management tools like Activity Based Costing (ABC), Activity Based Management (ABM) and Target Costing is required.
We can make a Difference:
Diversification is a form of growth strategy. Growth strategies involve a significant increase in performance objectives (usually sales or market share) beyond past levels of performance. Many organizations pursue one or more types of growth strategies. One of the primary reasons is the view held by many investors and executives that "bigger is better." Growth in sales is often used as a measure of performance. Even if profits remain stable or decline, an increase in sales satisfies many people. The assumption is often made that if sales increase, profits will eventually follow.
Growth may also improve the effectiveness of the organization. Larger companies have a number of advantages over smaller firms operating in more limited markets.
1. Large size or large market share can lead to economies of scale. Marketing or production synergies may result from more efficient use of sales calls, reduced travel time, reduced changeover time, and longer production runs.
2. Learning and experience curve effects may produce lower costs as the firm gains experience in producing and distributing its product or service. Experience and large size may also lead to improved layout, gains in labor efficiency, redesign of products or production processes, or larger and more qualified staff departments (e.g., marketing research or research and development).
3. Lower average unit costs may result from a firm's ability to spread administrative expenses and other overhead costs over a larger unit volume. The more capital intensive a business is, the more important its ability to spread costs across a large volume becomes.
4. Improved linkages with other stages of production can also result from large size. Better links with suppliers may be attained through large orders, which may produce lower costs (quantity discounts), improved delivery, or custom-made products that would be unaffordable for smaller operations. Links with distribution channels may lower costs by better location of warehouses, more efficient advertising, and shipping efficiencies. The size of the organization relative to its customers or suppliers influences its bargaining power and its ability to influence price and services provided.
5. Sharing of information between units of a large firm allows knowledge gained in one business unit to be applied to problems being experienced in another unit. Especially for companies relying heavily on technology, the reduction of R&D costs and the time needed to develop new technology may give larger firms an advantage over smaller, more specialized firms. The more similar the activities are among units, the easier the transfer of information becomes.
6. Taking advantage of geographic differences is possible for large firms. Especially for multinational firms, differences in wage rates, taxes, energy costs, shipping and freight charges, and trade restrictions influence the costs of business. A large firm can sometimes lower its cost of business by placing multiple plants in locations providing the lowest cost. Smaller firms with only one location must operate within the strengths and weaknesses of its single location.
Quality Assurance in Pharmaceutical Industry
Article Written By Mr. Piyush Tripathi
Quality Assurance in Pharmaceutical Industry
- Regulatory Norms, and QA Norms.
- QA implementation
- QA Focus
- QA upgrades
What is Quality Assurance?
Quality Assurance a “word of world”, a symbol and an assurance not only to the company but to an individual self as a reliable product identity, Quality assurance is most important and is always talked of but never explored. What is Quality Assurance? What does it do? What is its Importance? What Norms? What is the Use?. All these questions are always half way answered. With increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they apply to as global tool and an ensure safety and quality of drug. WHO (WORLD HEALTH ORGANIZATION) plays and applies continuous development of international norms and standards, to scale and implement standard and practices.
For safety and quality guidelines many organizations are playing a lead roll to ensure pharmaceuticals are also been promoted through regional and international efforts to harmonize drug regulation such as those led by, ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), the International Conference on Harmonization (ICH), MERCOSUR (Southern Common Market) the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC). These efforts are to be welcomed since international consensus on quality, safety and efficacy standards can speed up access to medicines.
Quality Assurance levels differ from country to country, not all countries have the same resource and capacity for implementation and agreements on drug regulation. Drug regulation step wise recommendation approach for achieving the highest possible level of medicine safety, regulation and quality assurance in each country is done by related authorities, experts and consultants. Authorities (WHO’S) role is to identify areas in which further guidance needs to be developed for preliminary and intermediate steps. Checklists based on test for detecting substandard and counterfeit drugs are just one example.
Advancement, modern technology and rapidly evolving science are creating problems for regulatory authorities everywhere. Training and specialization requirements for dealing with the increasing complexity of technological advanced products can be especially burdensome. Developing norms and standards for use in health technology and product development, “WHO” reduce this problem, while at the same time helping to minimize unnecessary duplication of scientific expertise and effort. Pharmaceutical industry is also bringing other safety issues like non-prescription medicines are becoming increasingly available to the general public in all countries, including though such channels as the Internet, monitoring their safety and quality are often lacking.
Quality Assurance In Pharma Industry:
In Pharma industry quality assurance is a broad concept covering all matters that collectively or individually influence the quality of drug or product. Quality assurance in pharmaceutical can be divided into four major areas:
1. Quality control
2. Production
3. Distribution and
4. Inspections.
Guidelines, norms and standards to promote quality assurance is an integral part of WHO’S constitution and has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those of the Revised Drug Strategy.
Guidelines, Norms, and standards
Quality assurance guidance for the respective divisions covers good manufacturing practices (GMP) Current Good Manufacturing Practices (cGMP), Quality assurance for regulatory approval; prequalification of medicines, laboratories and supply agencies; model certificates for quality assurance; quality control testing; new specification for inclusion in the basic test series and the international pharmacopoeia; and international chemical reference standards; the program on international nonproprietary names (INN) which is used to identify each pharmaceutical ingratiate or substance by a unique and universally accessible name. The need to scale up access to affordable quality medicines in developing countries has raised many challenges within the pharmaceutical world. These challenges are on top of the reality that among national regulatory authorities there is a variable capacity to interpret and apply existing norms and standards and guidelines on regulation quality control, nomenclature and classification of pharmaceuticals. WHO has strengthened and promoted global norms, standards and guidelines for the quality, safety and implication of medicine.
Accuracy Of Quality Assurance
QA primarily is metrics, or measurability. Process involves evaluation and testing to determine if the products meets specifications, such as performance measures. Results, involve delays in production until all rework or remediation steps have been undertaken. Cost related to products that do not meet minimum quality standards can be unacceptably high.
Steps For A Typical Quality Assurance Process
QA process has many scope and depth. The application of a process is often customized to the product process.
A typical process may include:
a. Test of previous Articles
b. Plan to improve
c. Design to include improvements and requirements
d. Manufacture with improvements
e. Review new item and improvements
f. Test of the new item
National Drug Regulatory Authorities (NDRAs) and pharmaceutical manufactures, as well as international bodies such as Global Fund to Fight AIDS, TB and Malaria (GFATM), AND UNICEF, all depend on the committee’s norms, standards and guidelines. These tools are also fundamental importance to such high profile initiatives as the UN prequalification program, the Global Malaria Programme and Stop TB. Originally mandated to develop The International Pharmacopoeia, the Committee has been seen its quality assurance role broaden and deepen significantly over the last 50 years. Convened annually, it addresses a range of subjects, from active and non-active pharmaceutical ingredients, to regulatory guidelines for marketing authorizations (registration) of medicines an effort that with such issues as stability testing, manufacturing variations and interchangeability. But whatever the subject, the aim remains constant: to promote quality assurance and quality control of pharmaceuticals.
The norms, standards and guidelines review by the committee are prepared through a rigorous consultative process involving WHO member States, National authorities and international agencies such as UNICEF. When applied, they form a basis of robust implementation of good manufacturing and distribution practices. They thus help avoid wasting public resources on medicines that are inefficient or even harmful. Providing sufficient resources for these normative activities is thus critical to sustaining vital public health programmes and by preventing duplication of efforts worldwide promotes cost effectiveness.
Available International Chemical Reference Substances (ICRS)
Chemical reference substances are an essential tool in a laboratory’s quality control testing of pharmaceuticals. They are used primarily to validate the test results obtained from a specific method, and are also used as primary standards to calibrate secondary standards. Following a complex procedure aligned with the WHO Guidelines on the Establishment, Maintenance and Distribution of Chemical Reference Substances, lists of these substances were adopted by the committee and are regularly updated to focus on essential medicines and medicines used in treating large populations, for which international quality requirements are often not publicly available. NDRAs and the quality control laboratories of pharmaceutical manufacturers use ICRS in physical and chemical test described in quality control specifications for medicine published in The International Pharmacopoeia.
WHO’s ICRS collection is developed, stored, monitored and distributed worldwide by the WHO Collaborating Centers for Chemical Reference Substances in Sweden. The Centre is responsible for obtaining candidate material, ensuring its purity and suitability through analytical tests, and reporting results with recommendations to WHO. In 2005, the Centre distributed a total of 1360 ICRS. Four new ICRS-didanosine, didanosine for system suitability; efavirenz; and nevirapine were adopted by the 41st Expert Committee.
General Guidelines For The Establishment, Maintenance And Distribution Of Chemical Reference Substances:
The requirements of National and regional pharmacopoeia, coupled with the need for greater availability and cost effectiveness, led to the establishment of chemical reference substances external to the WHO Collaborating Centre, and to the development of WHO guidelines to ensure the integrity of national and regional collections. Fist recommended by the committee in 1975, The General Guidelines for Establishment, Maintenance and Distribution of Chemical Reference Substances has undergone several revisions since. The most recent revision is concerned with both primary and secondary chemical reference substances. Part A provides guidance on primary chemical reference substances, materials whose assigned content when used as an assay standard are accepted without requiring comparison to another chemical substance. In response to the Committee’s 2004 recommendations, a new Part B provides more detailed guidance on establishing secondary reference substances, materials whose characteristics are calibrated by comparison with a primary chemical reference substance. This guidance applies primarily to secondary reference substances supplied as regional or national standards. Since producing maintaining and distributing ICRS is costly and time consuming, the guidelines also cover needs assessment (among other protocols). The most important steps addressed are: procuring source material; testing methods and packaging distribution and supply.
GMP for Heating, Ventilation and Air Conditioning (HVAC) Systems:
To ensure that pharmaceuticals are manufactured, packaged and stored in a controlled, uncontaminated environment is a necessary part of the Quality Assurance process. During production and storage, medicines must remain free form impurities, dust and foreign matter. Toxic substances must be contained to prevent there cross contaminating other medicines in adjacent areas or escaping into the outside environment. HVAC systems make this possible by maintaining the proper temperature, humidity and ventilation for medicines and equipment used during manufacture and storage. The guideline advises both manufacturers of solid dosage medicines and inspectors of these facilities on HVAC system design, installation, qualification and maintenance. However, most of the system design principles will also apply to facilities that manufacture medicines in other forms such as liquids, creams and ointments. Since the primary function of pharmaceutical manufacturer’s HVAC system is to prevent contamination and cross contaminations, its design should be part of the facility’s blue print. HVAC design influences the architectural layout of such elements as airlocks, which regulate air flow between rooms of differing classes of cleanliness, and environmentally controlled “CLEAN ROOMS”. HVAC system’s role is protection of pharmaceutical products, personnel and the environment during the manufacturing process.
Model quality Assurance System (MQAS) For Assessment of Procurement Agencies
Low cost pharmaceuticals of assured quality hold a great potential for maximizing the impact of efforts to combat communicable diseases such as HIV/AIDS, Malaria and tuberculosis (TB). Pharmaceutical supply has been a major concern at country and international level, with efforts to accelerate access to medicines highlighting the inadequacies of quality assurance mechanism applied to procurement agencies. While some of these agencies have quality assurance system in place, their extent and quality may vary widely. Without a harmonized system that seeks to ensure procurement of quality medicines for supply to patents, procurement agencies risk sourcing substandard, counterfeit or contaminated medicines. This undermines their credibility and results in product recalls, wasted money and particularly, health risks to patients. In response, the MQAS was designed by expert team, including specialists form UNICEF, UNFPA, WHO and the World Bank, to help these agencies achieve the goal of a quality procurement system. The Model is intended to guide them in developing their own quality assurance systems. It focuses on the four key activities: the prequalification of pharmaceutical products and manufacturers, and the purchase, storage and distribution of pharmaceuticals.
The International Pharmacopoeia
The International pharmacopoeia consists of a collection of quality specifications for pharmaceutical substances (APIs and excipients) and dosage forms, together with supporting general methods of analysis. It is intended to serve as source material for reference or adaptation by any WHO Member state wishing to establish Pharmaceutical requirements. The selection of monographs for inclusion in The International Pharmacopoeia recognizes the needs of specific disease programmes and the essential medicines nominated under these programmes. It is based primarily on those substances included in the current WHO Model List of Essential Medicines.
Equivalence Of Alternative Approaches to Quality Assurance:
The equivalence of alternative approaches to quality assurance should be validated. The guide as a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation. A new concept of hazard analysis related to the risks in production and personal safety is also newly recommended. The manufacturer should assure the safety of worker and take the necessary measures to prevent pollution of the external environment. International Nonproprietary Names (INNs) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.
Quality Management in Drug Industry:
In drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “Quality Policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:
- an appropriate infrastructure or “Quality System”, encompassing the organizational structure, procedures, processes and resources;
- systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed “QUALITY ASSURANCE”
Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier. The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
Principle: Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. Quality assurance therefore incorporates GMP and other factors, including product design and development.
The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
a. Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
b. Production and control operations are clearly specified in a written form and GMP requirements are adopted.
c. Managerial responsibilities are clearly specified
d. Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
e. All necessary controls on starting materials, intermediate products, and bulk products and other in process controls, calibrations, and validations are carried out and documented.
f. The finished product is correctly processed and checked, according to the defined procedures.
g. Pharmaceutical products are not sold or supplied before the authorized person have certified that each production batch has been marked authorization and any other regulations relevant to the production, control and release of pharmaceutical products.
h. Satisfactory arrangements exist to ensure, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf life.
i. There is a procedure for self inspection; quality audit that regularly appraises the effectiveness and applicability of the quality assurance system
j. Deviations are reported, investigated and recorded.
k. There is a system for approving changes that may have an impact on product quality.
l. Regular evaluations of the quality of pharmaceutical products should be conducted with the objective to verify the consistency of the process and ensure its continuous improvement.
GMP And Quality Assurance
Good Manufacturing Practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate ot their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: Cross contamination (In particular of unexpected contaminants) and mix ups (confusion) caused by, for example false labeled container. Under GMP Guidelines
a. All manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications.
b. Qualification and validation performed.
c. All necessary resources are provided: Including:
o Appropriately qualified and trained personnel
o Adequate premises and space
o Suitable equipment and services
o Appropriate material, container and labels
o Approved procedures and instructions
o Suitable storage and transport
o Adequate Personal, laboratories and equipment for in process control.
d. Instruction and procedures are written in clear and unambiguous language, specifically applicable to facilities provided.
e. Operators are trained to carry out procedures correctly.
f. Records are made (manually by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have been taken and quantify and quality of the product are expected; any significant deviations are fully recorded and investigated.
g. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form
h. The proper storage and distribution of the products minimizes any risk to their quality.
i. A system is available to recall any batch of product from sale or supply
j. Complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products to prevent recurrence.
The manufacture or company must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of concerns in many different departments and at all levels within any organization. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of quality assurance system should be adequately staffed with competent personal, and should have suitable and sufficient premises, equipment, and facilities.
Quality Assurance in Pharmaceutical Industry
- Regulatory Norms, and QA Norms.
- QA implementation
- QA Focus
- QA upgrades
What is Quality Assurance?
Quality Assurance a “word of world”, a symbol and an assurance not only to the company but to an individual self as a reliable product identity, Quality assurance is most important and is always talked of but never explored. What is Quality Assurance? What does it do? What is its Importance? What Norms? What is the Use?. All these questions are always half way answered. With increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they apply to as global tool and an ensure safety and quality of drug. WHO (WORLD HEALTH ORGANIZATION) plays and applies continuous development of international norms and standards, to scale and implement standard and practices.
For safety and quality guidelines many organizations are playing a lead roll to ensure pharmaceuticals are also been promoted through regional and international efforts to harmonize drug regulation such as those led by, ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), the International Conference on Harmonization (ICH), MERCOSUR (Southern Common Market) the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC). These efforts are to be welcomed since international consensus on quality, safety and efficacy standards can speed up access to medicines.
Quality Assurance levels differ from country to country, not all countries have the same resource and capacity for implementation and agreements on drug regulation. Drug regulation step wise recommendation approach for achieving the highest possible level of medicine safety, regulation and quality assurance in each country is done by related authorities, experts and consultants. Authorities (WHO’S) role is to identify areas in which further guidance needs to be developed for preliminary and intermediate steps. Checklists based on test for detecting substandard and counterfeit drugs are just one example.
Advancement, modern technology and rapidly evolving science are creating problems for regulatory authorities everywhere. Training and specialization requirements for dealing with the increasing complexity of technological advanced products can be especially burdensome. Developing norms and standards for use in health technology and product development, “WHO” reduce this problem, while at the same time helping to minimize unnecessary duplication of scientific expertise and effort. Pharmaceutical industry is also bringing other safety issues like non-prescription medicines are becoming increasingly available to the general public in all countries, including though such channels as the Internet, monitoring their safety and quality are often lacking.
Quality Assurance In Pharma Industry:
In Pharma industry quality assurance is a broad concept covering all matters that collectively or individually influence the quality of drug or product. Quality assurance in pharmaceutical can be divided into four major areas:
1. Quality control
2. Production
3. Distribution and
4. Inspections.
Guidelines, norms and standards to promote quality assurance is an integral part of WHO’S constitution and has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those of the Revised Drug Strategy.
Guidelines, Norms, and standards
Quality assurance guidance for the respective divisions covers good manufacturing practices (GMP) Current Good Manufacturing Practices (cGMP), Quality assurance for regulatory approval; prequalification of medicines, laboratories and supply agencies; model certificates for quality assurance; quality control testing; new specification for inclusion in the basic test series and the international pharmacopoeia; and international chemical reference standards; the program on international nonproprietary names (INN) which is used to identify each pharmaceutical ingratiate or substance by a unique and universally accessible name. The need to scale up access to affordable quality medicines in developing countries has raised many challenges within the pharmaceutical world. These challenges are on top of the reality that among national regulatory authorities there is a variable capacity to interpret and apply existing norms and standards and guidelines on regulation quality control, nomenclature and classification of pharmaceuticals. WHO has strengthened and promoted global norms, standards and guidelines for the quality, safety and implication of medicine.
Accuracy Of Quality Assurance
QA primarily is metrics, or measurability. Process involves evaluation and testing to determine if the products meets specifications, such as performance measures. Results, involve delays in production until all rework or remediation steps have been undertaken. Cost related to products that do not meet minimum quality standards can be unacceptably high.
Steps For A Typical Quality Assurance Process
QA process has many scope and depth. The application of a process is often customized to the product process.
A typical process may include:
a. Test of previous Articles
b. Plan to improve
c. Design to include improvements and requirements
d. Manufacture with improvements
e. Review new item and improvements
f. Test of the new item
National Drug Regulatory Authorities (NDRAs) and pharmaceutical manufactures, as well as international bodies such as Global Fund to Fight AIDS, TB and Malaria (GFATM), AND UNICEF, all depend on the committee’s norms, standards and guidelines. These tools are also fundamental importance to such high profile initiatives as the UN prequalification program, the Global Malaria Programme and Stop TB. Originally mandated to develop The International Pharmacopoeia, the Committee has been seen its quality assurance role broaden and deepen significantly over the last 50 years. Convened annually, it addresses a range of subjects, from active and non-active pharmaceutical ingredients, to regulatory guidelines for marketing authorizations (registration) of medicines an effort that with such issues as stability testing, manufacturing variations and interchangeability. But whatever the subject, the aim remains constant: to promote quality assurance and quality control of pharmaceuticals.
The norms, standards and guidelines review by the committee are prepared through a rigorous consultative process involving WHO member States, National authorities and international agencies such as UNICEF. When applied, they form a basis of robust implementation of good manufacturing and distribution practices. They thus help avoid wasting public resources on medicines that are inefficient or even harmful. Providing sufficient resources for these normative activities is thus critical to sustaining vital public health programmes and by preventing duplication of efforts worldwide promotes cost effectiveness.
Available International Chemical Reference Substances (ICRS)
Chemical reference substances are an essential tool in a laboratory’s quality control testing of pharmaceuticals. They are used primarily to validate the test results obtained from a specific method, and are also used as primary standards to calibrate secondary standards. Following a complex procedure aligned with the WHO Guidelines on the Establishment, Maintenance and Distribution of Chemical Reference Substances, lists of these substances were adopted by the committee and are regularly updated to focus on essential medicines and medicines used in treating large populations, for which international quality requirements are often not publicly available. NDRAs and the quality control laboratories of pharmaceutical manufacturers use ICRS in physical and chemical test described in quality control specifications for medicine published in The International Pharmacopoeia.
WHO’s ICRS collection is developed, stored, monitored and distributed worldwide by the WHO Collaborating Centers for Chemical Reference Substances in Sweden. The Centre is responsible for obtaining candidate material, ensuring its purity and suitability through analytical tests, and reporting results with recommendations to WHO. In 2005, the Centre distributed a total of 1360 ICRS. Four new ICRS-didanosine, didanosine for system suitability; efavirenz; and nevirapine were adopted by the 41st Expert Committee.
General Guidelines For The Establishment, Maintenance And Distribution Of Chemical Reference Substances:
The requirements of National and regional pharmacopoeia, coupled with the need for greater availability and cost effectiveness, led to the establishment of chemical reference substances external to the WHO Collaborating Centre, and to the development of WHO guidelines to ensure the integrity of national and regional collections. Fist recommended by the committee in 1975, The General Guidelines for Establishment, Maintenance and Distribution of Chemical Reference Substances has undergone several revisions since. The most recent revision is concerned with both primary and secondary chemical reference substances. Part A provides guidance on primary chemical reference substances, materials whose assigned content when used as an assay standard are accepted without requiring comparison to another chemical substance. In response to the Committee’s 2004 recommendations, a new Part B provides more detailed guidance on establishing secondary reference substances, materials whose characteristics are calibrated by comparison with a primary chemical reference substance. This guidance applies primarily to secondary reference substances supplied as regional or national standards. Since producing maintaining and distributing ICRS is costly and time consuming, the guidelines also cover needs assessment (among other protocols). The most important steps addressed are: procuring source material; testing methods and packaging distribution and supply.
GMP for Heating, Ventilation and Air Conditioning (HVAC) Systems:
To ensure that pharmaceuticals are manufactured, packaged and stored in a controlled, uncontaminated environment is a necessary part of the Quality Assurance process. During production and storage, medicines must remain free form impurities, dust and foreign matter. Toxic substances must be contained to prevent there cross contaminating other medicines in adjacent areas or escaping into the outside environment. HVAC systems make this possible by maintaining the proper temperature, humidity and ventilation for medicines and equipment used during manufacture and storage. The guideline advises both manufacturers of solid dosage medicines and inspectors of these facilities on HVAC system design, installation, qualification and maintenance. However, most of the system design principles will also apply to facilities that manufacture medicines in other forms such as liquids, creams and ointments. Since the primary function of pharmaceutical manufacturer’s HVAC system is to prevent contamination and cross contaminations, its design should be part of the facility’s blue print. HVAC design influences the architectural layout of such elements as airlocks, which regulate air flow between rooms of differing classes of cleanliness, and environmentally controlled “CLEAN ROOMS”. HVAC system’s role is protection of pharmaceutical products, personnel and the environment during the manufacturing process.
Model quality Assurance System (MQAS) For Assessment of Procurement Agencies
Low cost pharmaceuticals of assured quality hold a great potential for maximizing the impact of efforts to combat communicable diseases such as HIV/AIDS, Malaria and tuberculosis (TB). Pharmaceutical supply has been a major concern at country and international level, with efforts to accelerate access to medicines highlighting the inadequacies of quality assurance mechanism applied to procurement agencies. While some of these agencies have quality assurance system in place, their extent and quality may vary widely. Without a harmonized system that seeks to ensure procurement of quality medicines for supply to patents, procurement agencies risk sourcing substandard, counterfeit or contaminated medicines. This undermines their credibility and results in product recalls, wasted money and particularly, health risks to patients. In response, the MQAS was designed by expert team, including specialists form UNICEF, UNFPA, WHO and the World Bank, to help these agencies achieve the goal of a quality procurement system. The Model is intended to guide them in developing their own quality assurance systems. It focuses on the four key activities: the prequalification of pharmaceutical products and manufacturers, and the purchase, storage and distribution of pharmaceuticals.
The International Pharmacopoeia
The International pharmacopoeia consists of a collection of quality specifications for pharmaceutical substances (APIs and excipients) and dosage forms, together with supporting general methods of analysis. It is intended to serve as source material for reference or adaptation by any WHO Member state wishing to establish Pharmaceutical requirements. The selection of monographs for inclusion in The International Pharmacopoeia recognizes the needs of specific disease programmes and the essential medicines nominated under these programmes. It is based primarily on those substances included in the current WHO Model List of Essential Medicines.
Equivalence Of Alternative Approaches to Quality Assurance:
The equivalence of alternative approaches to quality assurance should be validated. The guide as a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation. A new concept of hazard analysis related to the risks in production and personal safety is also newly recommended. The manufacturer should assure the safety of worker and take the necessary measures to prevent pollution of the external environment. International Nonproprietary Names (INNs) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.
Quality Management in Drug Industry:
In drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “Quality Policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:
- an appropriate infrastructure or “Quality System”, encompassing the organizational structure, procedures, processes and resources;
- systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed “QUALITY ASSURANCE”
Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier. The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
Principle: Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. Quality assurance therefore incorporates GMP and other factors, including product design and development.
The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
a. Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
b. Production and control operations are clearly specified in a written form and GMP requirements are adopted.
c. Managerial responsibilities are clearly specified
d. Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
e. All necessary controls on starting materials, intermediate products, and bulk products and other in process controls, calibrations, and validations are carried out and documented.
f. The finished product is correctly processed and checked, according to the defined procedures.
g. Pharmaceutical products are not sold or supplied before the authorized person have certified that each production batch has been marked authorization and any other regulations relevant to the production, control and release of pharmaceutical products.
h. Satisfactory arrangements exist to ensure, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf life.
i. There is a procedure for self inspection; quality audit that regularly appraises the effectiveness and applicability of the quality assurance system
j. Deviations are reported, investigated and recorded.
k. There is a system for approving changes that may have an impact on product quality.
l. Regular evaluations of the quality of pharmaceutical products should be conducted with the objective to verify the consistency of the process and ensure its continuous improvement.
GMP And Quality Assurance
Good Manufacturing Practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate ot their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: Cross contamination (In particular of unexpected contaminants) and mix ups (confusion) caused by, for example false labeled container. Under GMP Guidelines
a. All manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications.
b. Qualification and validation performed.
c. All necessary resources are provided: Including:
o Appropriately qualified and trained personnel
o Adequate premises and space
o Suitable equipment and services
o Appropriate material, container and labels
o Approved procedures and instructions
o Suitable storage and transport
o Adequate Personal, laboratories and equipment for in process control.
d. Instruction and procedures are written in clear and unambiguous language, specifically applicable to facilities provided.
e. Operators are trained to carry out procedures correctly.
f. Records are made (manually by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have been taken and quantify and quality of the product are expected; any significant deviations are fully recorded and investigated.
g. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form
h. The proper storage and distribution of the products minimizes any risk to their quality.
i. A system is available to recall any batch of product from sale or supply
j. Complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products to prevent recurrence.
The manufacture or company must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of concerns in many different departments and at all levels within any organization. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of quality assurance system should be adequately staffed with competent personal, and should have suitable and sufficient premises, equipment, and facilities.
Boost Your Business Using Internet Marketing Promotion
Boost Your Business Using Internet Marketing Promotion
There are several ways to boost your business in the internet marketing promotion world. There's article marketing, videos, audio, playing around in social network communities, business communities, forums, email marketing, lead generation, exchanges, joint-venture partnerships, and various other ways to make this happen. However, you will have to strategize a plan or all of it will get you nowhere.
If you're the owner of a small service business, having a solid Internet marketing plan in place can both increase your name and brand recognition locally in your geographic area, as well as expose you to a whole new set of potential clients throughout the world.
Marketing Plan
What do you want to accomplish by using Internet marketing? To find new clients? Provide services and info to existing clients? Sell services or products? Educate your target market or your staff about your product or service? Create an online community for your target market? How much money to have to spend each month on this Internet marketing plan? Having a goal and budget in mind will make your marketing more effective.
Track competition
Knowing and understanding where you stand among your competitors can you help you strengthen your marketing message. Do a keyword search for the terms someone might use to find your business online. Write down the URL's of your top 5 competitors. How popular and relevant are their sites? You can check their traffic ranking with Alexa, http://www.alexa.com/#traffic, as well as see what other sites link to them. Does your competition offer something unique? Where are the gaps in the service or product offerings?
Target Market:
Instead of trying to marketing to everyone (the shotgun marketing approach), find a clearly definable target market that you can easily describe and locate. What industry? What socio-economic group? What do they read? To what groups and associations (real and virtual, personal and professional) do they belong? How much money do they make? Can they easily afford your product or service? What keywords are they using to search for businesses like yours online? (Note--you can do keyword research with free downloadable software, http://www.GoodKeywords.com).
Solution to a Problem:
The reason that someone will buy your product or hire to you to provide a service is to solve a particular problem that they have. What problems and issues plague your target market? How does your product or service solve that problem? How does your solution differ from that of your competitors? What makes you uniquely qualified to provide the solution to their problem?
Branding Your Business:
Your domain name can either help you be memorable or cast you into a sea of "brandless" solutions. At a minimum, you'll want to buy both your personal name as well as the name of your business in the .com version, if it's available. Then buy the .com versions of your product names and program names. If you use a full-featured domain registrar, you'll be able to point and mask these domains to internal pages of your web site, or use them as stand-alone sales letter pages.
You may also think of problems faced by your target market or solutions that you provide and buy domain names in the .com version of those as well.
Assess your website.
Your web site should be visually appealing, with one primary font for the text and a simple primary color scheme, along with an easy-to-navigate layout, and readily identifiable buttons to link to other pages in the site. Your content should focus on and address the problems of your visitors and how your product or service can help solve their problems. Rather than listing the features of your product or service, detail the benefits they'll gain from purchasing your product or service. People rarely buy features -- they buy benefits. Don't depend on your web site designer to write your content -- that is best done by you, as you know your business and your target market better than anyone.
Present a clear call to action that is clearly shown on every page of your site. In an online business, your primary call to action should be getting the visitor's name and primary email address by asking him subscribe to your ezine or by giving him access to a free ecourse, special report, audio recording, or ebook. Lastly, provide an abundance of readily available information to demonstrate your expertise (articles, blog posts, free downloads, giveaways, contests). Your visitor is always asking WIIFM (What's In It For Me) -- make your web site about your visitor, not about you.
Internet Marketing Strategies:
How will you create traffic to your website? There are countless ways to do this, including: pay-per-click purchases (in which you buy a keyword at a search engine and pay for placement on that search engine for that keyword and pay for each visitor who clicks on that link and is sent to your site); organic search engine listing ranking (in which your site comes up at the top of the non-sponsored listings on a search engine by having keyword rich descriptions in the page title and page description meta tags and then optimizing each page for no more than 3 keywords in the first 250 words on a page); well-written email newsletter that is published on a regular basis; submission of articles on topics related to your target market to article submission directories; regularly post entries to a blog aimed at your target market, full of content discussing issues related to that target market; series of podcasts containing interview with experts of interest to your target market; ongoing series of teleconferences containing value-added content for your target market; submission of online press releases with new tips information for your target market; exchange relevant links with others in different industries with the same target market;
There are several ways to boost your business in the internet marketing promotion world. There's article marketing, videos, audio, playing around in social network communities, business communities, forums, email marketing, lead generation, exchanges, joint-venture partnerships, and various other ways to make this happen. However, you will have to strategize a plan or all of it will get you nowhere.
If you're the owner of a small service business, having a solid Internet marketing plan in place can both increase your name and brand recognition locally in your geographic area, as well as expose you to a whole new set of potential clients throughout the world.
Marketing Plan
What do you want to accomplish by using Internet marketing? To find new clients? Provide services and info to existing clients? Sell services or products? Educate your target market or your staff about your product or service? Create an online community for your target market? How much money to have to spend each month on this Internet marketing plan? Having a goal and budget in mind will make your marketing more effective.
Track competition
Knowing and understanding where you stand among your competitors can you help you strengthen your marketing message. Do a keyword search for the terms someone might use to find your business online. Write down the URL's of your top 5 competitors. How popular and relevant are their sites? You can check their traffic ranking with Alexa, http://www.alexa.com/#traffic, as well as see what other sites link to them. Does your competition offer something unique? Where are the gaps in the service or product offerings?
Target Market:
Instead of trying to marketing to everyone (the shotgun marketing approach), find a clearly definable target market that you can easily describe and locate. What industry? What socio-economic group? What do they read? To what groups and associations (real and virtual, personal and professional) do they belong? How much money do they make? Can they easily afford your product or service? What keywords are they using to search for businesses like yours online? (Note--you can do keyword research with free downloadable software, http://www.GoodKeywords.com).
Solution to a Problem:
The reason that someone will buy your product or hire to you to provide a service is to solve a particular problem that they have. What problems and issues plague your target market? How does your product or service solve that problem? How does your solution differ from that of your competitors? What makes you uniquely qualified to provide the solution to their problem?
Branding Your Business:
Your domain name can either help you be memorable or cast you into a sea of "brandless" solutions. At a minimum, you'll want to buy both your personal name as well as the name of your business in the .com version, if it's available. Then buy the .com versions of your product names and program names. If you use a full-featured domain registrar, you'll be able to point and mask these domains to internal pages of your web site, or use them as stand-alone sales letter pages.
You may also think of problems faced by your target market or solutions that you provide and buy domain names in the .com version of those as well.
Assess your website.
Your web site should be visually appealing, with one primary font for the text and a simple primary color scheme, along with an easy-to-navigate layout, and readily identifiable buttons to link to other pages in the site. Your content should focus on and address the problems of your visitors and how your product or service can help solve their problems. Rather than listing the features of your product or service, detail the benefits they'll gain from purchasing your product or service. People rarely buy features -- they buy benefits. Don't depend on your web site designer to write your content -- that is best done by you, as you know your business and your target market better than anyone.
Present a clear call to action that is clearly shown on every page of your site. In an online business, your primary call to action should be getting the visitor's name and primary email address by asking him subscribe to your ezine or by giving him access to a free ecourse, special report, audio recording, or ebook. Lastly, provide an abundance of readily available information to demonstrate your expertise (articles, blog posts, free downloads, giveaways, contests). Your visitor is always asking WIIFM (What's In It For Me) -- make your web site about your visitor, not about you.
Internet Marketing Strategies:
How will you create traffic to your website? There are countless ways to do this, including: pay-per-click purchases (in which you buy a keyword at a search engine and pay for placement on that search engine for that keyword and pay for each visitor who clicks on that link and is sent to your site); organic search engine listing ranking (in which your site comes up at the top of the non-sponsored listings on a search engine by having keyword rich descriptions in the page title and page description meta tags and then optimizing each page for no more than 3 keywords in the first 250 words on a page); well-written email newsletter that is published on a regular basis; submission of articles on topics related to your target market to article submission directories; regularly post entries to a blog aimed at your target market, full of content discussing issues related to that target market; series of podcasts containing interview with experts of interest to your target market; ongoing series of teleconferences containing value-added content for your target market; submission of online press releases with new tips information for your target market; exchange relevant links with others in different industries with the same target market;
EVOLUTION OF TRANSFORMING TECHNOLOGY: BY PIYUSH TRIPATHI
The art of the drug compounder Pharmacopoeia, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
HISTORY
• Arabic Book of Simple Drugs from Dioscorides’ De Materia Medica. Cumin & dill. c. 1334 By Kathleen Cohen in London's British Museum.
• Dioscorides, De Materia Medica, Byzantium, 15th century.
• Dioscorides De Materia Medica in Arabic, Spain, 12th-13th century.
Pharmacopoeia is considered to be the cradle of pharmacotherapy. Pedanius Dioscorides is famous for writing a five volume book in his native Greek (De Materia Medica - in the Latin translation) that is a precursor to all modern pharmacopoeias, and is one of the most influential herbal books in history. In fact it remained in use until about CE 1600.
Pharmacopoeia books were written by Persian physicians. These included The Canon of Medicine of Avicenna in 1025, and other pharmacopoeia books by Abu-Rayhan Biruni in the 11th century, Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), and Ibn Baytar in the 14th century.
The term pharmacopoeia first appears as a distinct title in a work published at Basel in 1561 by Dr A. Foes, but does not appear to have come into general use until the beginning of the 17th century.
Over the years and century many revision and consideration from authorities, and regulatory act changed comities were formed. Finally, the first Edinburgh Pharmacopoeia was published in 1699 and the last in 1841; the first Dublin Pharmacopoeia in 1807 and the last in 1850.
The preparations contained in these three pharmacopoeias were not all uniform in strength, a source of much inconvenience and danger to the public, when powerful preparations such as dilute hydrocyanic acid were ordered in the one country and dispensed according to the national pharmacopoeia in another. As a result, the Medical Act of 1858 ordained that the General Medical Council should publish a book containing a list of medicines and compounds, to be called the British Pharmacopoeia, which would be a substitute throughout Great Britain and Ireland for the separate pharmacopoeias. Hitherto these had been published in Latin. The first British Pharmacopoeia was published in the English language in 1864, but gave such general dissatisfaction both to the medical profession and to chemists and druggists that the General Medical Council brought out a new and amended edition in 1867. This dissatisfaction was probably owing partly to the fact that the majority of the compilers of the work were not engaged in the practice of pharmacy, and therefore competent rather to decide upon the kind of preparations required than upon the method of their manufacture. The necessity for this element in the construction of a pharmacopoeia is now fully recognized in other countries, in most of which pharmaceutical chemists are represented on the committee for the preparation of the legally recognized manuals.
There are national and international pharmacopoeias, like the EU and the US pharmacopoeias. All the pharmacopoeias were issued under the authority of government, and their instructions have the force of law in their respective territories, except that of the United States, which was prepared by commissioners appointed by medical and pharmaceutical societies, and has no other authority, although generally accepted as the national textbook.
Increased facilities for travel have brought into greater prominence the importance of an approach to uniformity in the formulae of the more powerful remedies, in order to avoid danger to patients when a prescription is dispensed in a different country from that in which it was written. Nonetheless, some progress has been made under the banner of the ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use:www.ich.org), a tri-regional organisation that represents the drug regulatory authorities of the European Union, Japan and the United States. Representatives from the Pharmacopoeias of these three regions have met twice yearly since 1990 in the Pharmacopoeial Discussion Group to try to work towards "compendial harmonisation"’. Specific monographs are proposed, and if accepted, proceed through stages of review and consultation leading to adoption of a common monograph that provides a common set of tests and specifications for a specific material.
The rapid increase in medical and pharmaceutical knowledge renders necessary frequent new editions of the national pharmacopoeias, the office of which is to furnish definite formulae for preparations that have already come into extensive use in medical practice, so as to ensure uniformity of strength, and to give the characters and tests by which their purity and potency may be determined. each new edition requires several years to carry out numerous experiments for devising suitable formulae, so that the current Pharmacopoeia can never be quite up to date. This difficulty has hitherto been met by the publication of such nonofficial formularies as Squire's Companion to the Pharmacopoeia and Martindale: The complete drug reference (formerly Martindale's : The Extra Pharmacopoeia), in which all new remedies and their preparations, uses and doses are recorded, and in the former the varying strengths of the same preparations in the different pharmacopoeias are also compared (Squire's was incorporated into Martindal in 1952). The need of such works to supplement the Pharmacopoeia is shown by the fact that they are even more largely used than the Pharmacopoeia itself, the first issued in 18 editions and the second in 13 editions at comparatively short intervals. In the UK, the task of elaborating a new Pharmacopoeia is entrusted to a body of a purely medical character, and legally the pharmacist has not, contrary to the practice in other countries, a voice in the matter, notwithstanding the fact that, although the medical practitioner is naturally the best judge of the drug or preparations that will afford the best therapeutic result, he is not so competent as the pharmacist to say how that preparation can be produced in the most effective and satisfactory manner, nor how the purity of drugs can be tested.
Some difficulty has arisen since the passing of the Adulteration of Food and Drugs Act[citation needed] concerning the use of the Pharmacopoeia as a legal standard for the drugs and preparations contained in it. The Pharmacopoeia is defined in the preface as only "intended to afford to the members of the medical profession and those engaged in the preparation of medicines throughout the British Empire one uniform standard and guide whereby the nature and composition of, substances to be used in medicine may be ascertained and determined." It is obvious that it cannot be an encyclopaedia of substances used in medicine, and can only be used as a standard for the substances and preparations contained in it, and for no others. It has been held in the Divisional Courts (Dickins v. Randerson) that the Pharmacopoeia is a standard for official preparations asked for under their pharmacopoeial name. But there are many substances in the Pharmacopoeia which are not only employed in medicine, but have other uses, such as sulphur, gum benzoin, tragacanth, gum arabic, ammonium carbonate, beeswax, oil of turpentine, linseed oil, and for these a commercial standard of purity as distinct from a medicinal one is needed, since the preparations used in medicine should be of the highest possible degree of purity obtainable, and this standard would be too high and too expensive for ordinary purposes. The use of trade synonyms in the Pharmacopoeia, such as saltpetre for purified potassium nitrate, and milk of sulphur for precipitated sulphur, is partly answerable for this difficulty, and has proved to be a mistake, since it affords ground for legal prosecution if a chemist sells a drug of ordinary commercial purity for trade purposes, instead of the purified preparation which is official in the Pharmacopoeia for medicinal use. This would not be the case if the trade synonym were omitted. For many drugs and chemicals not in the Pharmacopoeia there is no standard of purity that can be used under the Adulteration of Food and Drugs Act, and for these, as well as for the commercial quality of those drugs and essential oils which are also in the Pharmacopoeia, a legal standard of commercial purity is much needed. This subject formed the basis of discussion at several meetings of the Pharmaceutical Society, and the results have been embodied in a work entitled Suggested Standards for Foods and Drugs, by C. G. Moor, which indicates the average degree of purity of many drugs and chemicals used in the arts, as well as the highest degree of purity obtainable in commerce of those used in medicine.
Another legal difficulty connected with modern pharmacopoeias is the inclusion in some of them of synthetic chemical remedies, the processes for preparing which have been patented, whilst the substances are sold under trade-mark names such as verona. The scientific chemical name is often long and unwieldy, and the physician prefers when writing a prescription to use the shorter name under which it is sold by the patentees. In this case the pharmacist is compelled to use the more expensive patented article and the patient complains of the price. If he uses the same article under its pharmacopoeial name when the patented article is prescribed s/he lays oneself open to prosecution by the patentee for infringement of patent rights. The only plan, therefore, is for the physician to use the chemical name (which cannot be patented) as given in the Pharmacopoeia, or for those synthetic remedies not included in the Pharmacopoeia, to use the scientific and chemical name given in the British Pharmaceutical Codex.
TRANSFORMATION
From new discoveries to developments, pharmacopoeia guides to technology, the interactions that occur between a living organism and exogenous chemicals that alter normal biochemical function. Substances with medicinal properties, are considered pharmaceuticals. The field encompasses drug composition and properties, interactions, toxicology, therapy, and medical applications and antipathogenic capabilities. A variety of topics involved with pharmacology, including neuropharmacology, renal pharmacology, human metabolism, intracellular metabolism, and intracellular regulation. Pharmacology is not synonymous with pharmacy, which is the name used for a profession, though in common usage the two terms are confused at times. Pharmacology deals with how drugs interact within biological systems to affect function. It is the study of drugs, of the body's reaction to drugs, the sources of drugs, their nature, and their properties. In contrast, pharmacy is a medical science concerned with the safe and effective use of medicines.
An origin of clinical pharmacology is in middle Ages in Avicenna's The Canon of Medicine, Peter of Spain's Commentary on Isaac, and John of St Amand's Commentary on the Antedotary of Nicholas. Pharmacology as a scientific discipline did not further advance until the mid-19th century amid the great biomedical resurgence of that period. Before the second half of the nineteenth century, the remarkable potency and specificity of the actions of drugs such as morphine, quinine and digitalis were explained vaguely and with reference to extraordinary chemical powers and affinities to certain organs or tissues. The first pharmacology department was set up by Buchheim in 1847, in recognition of the need to understand how therapeutic drugs and poisons produced their effects.
In the United States, the Food and Drug Administration (FDA) is responsible for creating guidelines for the approval and use of drugs. The FDA requires that all approved drugs fulfill two requirements:
1. The drug must be found to be effective against the disease for which it is seeking approval.
2. The drug must meet safety criteria by being subject to extensive animal and controlled human testing.
Gaining FDA approval usually takes several years to attain. Testing done on animals must be extensive and must include several species to help in the evaluation of both the effectiveness and toxicity of the drug. The dosage of any drug approved for use is intended to fall within a range in which the drug produces a therapeutic effect or desired outcome.
The safety and effectiveness of prescription drugs in the U.S. is regulated by the federal Prescription Drug Marketing Act of 1987.
The Medicines and Healthcare products Regulatory Agency (MHRA) has a similar role in the UK.
Early pharmacologists focused on natural substances, mainly plant extracts. Pharmacology developed in the 19th century as a biomedical science that applied the principles of scientific experimentation to therapeutic contexts.
The genetic revolution has pushed to the forefront a concept that is at the very heart of pharmacology and therapeutics – the right drug for the right target in the right patient and delivered at the right dose. In some areas such as cancer treatments, examples of specific tumour mutations that dictate the response to drugs is a reality. This will influence the nature of future clinical trials. The bigger challenge lies in understanding whether the same will be true for common germline genetic variation (polymorphisms) in the general population. Will common genetic variation influence response to treatment? The complexity of turning this into a clinically meaningful risk score is such that attention has turned towards pharmaceuticals. Is drug failure due in individual patients due to genetic variation? Could drug safety be improved by taking into account individual genetic risk? Data on genetic variation influencing efficacy are sparse.
On another level, by taking reductionism and integrated approaches, genetics and molecular pharmacology are beginning to unravel the enigmatic problem of drug receptor heterogeneity. The future promises new generations of drugs that could selectively target one subtype in a family of similar proteins to the therapeutic advantage of the patient while limiting commonly accepted and often debilitating side effects.
Pharmacology as a chemical science is practiced by pharmacologists. Viz.:
• Clinical pharmacology - the medical field of medication effects on humans
Clinical pharmacology connects the gap between medical practice and laboratory science. The main objective is to promote the safety of prescription, maximize the drug effects and minimize the side effects. It is important that there be association with pharmacists skilled in areas of drug information, medication safety and other aspects of pharmacy practice related to clinical pharmacology.
Clinical pharmacologists have a rigorous medical and scientific training which enables them to evaluate evidence and produce new data through well designed studies. Clinical pharmacologists have access to enough outpatients for clinical care, teaching and education, and research as well be supervised by medical specialists. Their responsibilities to patients include, but are not limited to analyzing adverse drug effects, therapeutics, and toxicology including reproductive toxicology, cardiovascular risks, perioperative drug management and psychopharmacology.
• Neuro- and psychopharmacology (effects of medication on behavior and nervous system functioning),
Neuro is a study a wide range of substances with various types of psychoactive properties. The professional and commercial fields of pharmacology and psychopharmacology do not mainly focus on psychedelic or recreational drugs, as the majority of studies are conducted for the development, study, and use of drugs for the modification of behavior and the alleviation of symptoms, particularly in the treatment of mental disorders (psychiatric medication). While studies are conducted on all psychoactives by both fields, psychopharmacology focuses primarily on the psychoactive and chemical interactions with the brain.
Psychoactive drugs may originate from natural sources such as plants and animals, or from artificial sources such as chemical synthesis in the laboratory. These drugs interact with particular target sites or receptors found in the nervous system to induce widespread changes in physiological or psychological functions.
• Pharmacogenetics (clinical testing of genetic variation that gives rise to differing response to drugs)
The terms pharmacogenomics and pharmacogenetics tend to be used interchangeably, and a precise, consensus definition of either remains elusive. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing response to drugs, while pharmacogenomics is the broader application of genomic technologies to new drug discovery and further characterization of older drugs.
• Pharmacogenomics (application of genomic technologies to new drug discovery and further characterization of older drugs)
Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. By doing so, pharmacogenomics aims to develop rational means to optimise drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Such approaches are advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup.
Pharmacogenomics is the whole genome application of pharmacogenetics, which examines the single gene interactions with drugs.
• Pharmacoepidemiology (study of effects of drugs in large numbers of people)
Pharmacoepidemiology borrows from both pharmacology and epidemiology. Thus, pharmacoepidemiology can be called a bridge science spanning both pharmacology and epidemiology. Pharmacology is the study of the effect of drugs and clinical pharmacology is the study of effect of drugs in humans. Part of the task of clinical pharmacology is to provide a risk benefit assessment for the effect of drugs in patients. Doing the studies needed to provide an estimate of the probability of beneficial effects in populations, or the probability of adverse effects in populations and other parameters relating to drug use may benefit from using epidemiological methodology. Pharmacoepidemiology then can also be defined as the application of epidemiological methods to pharmacological issues.
Pharmacoepidemiology benefits from the methodology developed in general epidemiology and may further develop them for applications of such methodology unique to pharmacoepidemiology. There are also some areas that are altogether unique to pharmacoepidemiology, e.g., pharmacovigilance. Pharmacovigilance is a type of continual monitoring for unwanted effects and other safety-related aspects of drugs that are already on the market. In practice, pharmacovigilance refers almost exclusively to the spontaneous reporting systems which allow health care professionals and others to report adverse drug reactions to a central agency. The central agency can then combine reports from many sources to produce a more informative safety profile for the drug product than could be done based on one or a few reports from one or a few health care professionals.
• Toxicology study of harmful effects of drugs
Study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people.
Theoretical pharmacology
Posology - how medicines are dosed
Pharmacognosy a branch of pharmacology dealing especially with the composition, use, and development of medicinal substances of biological origin and especially medicinal substances obtained from plants also known as deriving medicines from plants
HISTORY
• Arabic Book of Simple Drugs from Dioscorides’ De Materia Medica. Cumin & dill. c. 1334 By Kathleen Cohen in London's British Museum.
• Dioscorides, De Materia Medica, Byzantium, 15th century.
• Dioscorides De Materia Medica in Arabic, Spain, 12th-13th century.
Pharmacopoeia is considered to be the cradle of pharmacotherapy. Pedanius Dioscorides is famous for writing a five volume book in his native Greek (De Materia Medica - in the Latin translation) that is a precursor to all modern pharmacopoeias, and is one of the most influential herbal books in history. In fact it remained in use until about CE 1600.
Pharmacopoeia books were written by Persian physicians. These included The Canon of Medicine of Avicenna in 1025, and other pharmacopoeia books by Abu-Rayhan Biruni in the 11th century, Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), and Ibn Baytar in the 14th century.
The term pharmacopoeia first appears as a distinct title in a work published at Basel in 1561 by Dr A. Foes, but does not appear to have come into general use until the beginning of the 17th century.
Over the years and century many revision and consideration from authorities, and regulatory act changed comities were formed. Finally, the first Edinburgh Pharmacopoeia was published in 1699 and the last in 1841; the first Dublin Pharmacopoeia in 1807 and the last in 1850.
The preparations contained in these three pharmacopoeias were not all uniform in strength, a source of much inconvenience and danger to the public, when powerful preparations such as dilute hydrocyanic acid were ordered in the one country and dispensed according to the national pharmacopoeia in another. As a result, the Medical Act of 1858 ordained that the General Medical Council should publish a book containing a list of medicines and compounds, to be called the British Pharmacopoeia, which would be a substitute throughout Great Britain and Ireland for the separate pharmacopoeias. Hitherto these had been published in Latin. The first British Pharmacopoeia was published in the English language in 1864, but gave such general dissatisfaction both to the medical profession and to chemists and druggists that the General Medical Council brought out a new and amended edition in 1867. This dissatisfaction was probably owing partly to the fact that the majority of the compilers of the work were not engaged in the practice of pharmacy, and therefore competent rather to decide upon the kind of preparations required than upon the method of their manufacture. The necessity for this element in the construction of a pharmacopoeia is now fully recognized in other countries, in most of which pharmaceutical chemists are represented on the committee for the preparation of the legally recognized manuals.
There are national and international pharmacopoeias, like the EU and the US pharmacopoeias. All the pharmacopoeias were issued under the authority of government, and their instructions have the force of law in their respective territories, except that of the United States, which was prepared by commissioners appointed by medical and pharmaceutical societies, and has no other authority, although generally accepted as the national textbook.
Increased facilities for travel have brought into greater prominence the importance of an approach to uniformity in the formulae of the more powerful remedies, in order to avoid danger to patients when a prescription is dispensed in a different country from that in which it was written. Nonetheless, some progress has been made under the banner of the ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use:www.ich.org), a tri-regional organisation that represents the drug regulatory authorities of the European Union, Japan and the United States. Representatives from the Pharmacopoeias of these three regions have met twice yearly since 1990 in the Pharmacopoeial Discussion Group to try to work towards "compendial harmonisation"’. Specific monographs are proposed, and if accepted, proceed through stages of review and consultation leading to adoption of a common monograph that provides a common set of tests and specifications for a specific material.
The rapid increase in medical and pharmaceutical knowledge renders necessary frequent new editions of the national pharmacopoeias, the office of which is to furnish definite formulae for preparations that have already come into extensive use in medical practice, so as to ensure uniformity of strength, and to give the characters and tests by which their purity and potency may be determined. each new edition requires several years to carry out numerous experiments for devising suitable formulae, so that the current Pharmacopoeia can never be quite up to date. This difficulty has hitherto been met by the publication of such nonofficial formularies as Squire's Companion to the Pharmacopoeia and Martindale: The complete drug reference (formerly Martindale's : The Extra Pharmacopoeia), in which all new remedies and their preparations, uses and doses are recorded, and in the former the varying strengths of the same preparations in the different pharmacopoeias are also compared (Squire's was incorporated into Martindal in 1952). The need of such works to supplement the Pharmacopoeia is shown by the fact that they are even more largely used than the Pharmacopoeia itself, the first issued in 18 editions and the second in 13 editions at comparatively short intervals. In the UK, the task of elaborating a new Pharmacopoeia is entrusted to a body of a purely medical character, and legally the pharmacist has not, contrary to the practice in other countries, a voice in the matter, notwithstanding the fact that, although the medical practitioner is naturally the best judge of the drug or preparations that will afford the best therapeutic result, he is not so competent as the pharmacist to say how that preparation can be produced in the most effective and satisfactory manner, nor how the purity of drugs can be tested.
Some difficulty has arisen since the passing of the Adulteration of Food and Drugs Act[citation needed] concerning the use of the Pharmacopoeia as a legal standard for the drugs and preparations contained in it. The Pharmacopoeia is defined in the preface as only "intended to afford to the members of the medical profession and those engaged in the preparation of medicines throughout the British Empire one uniform standard and guide whereby the nature and composition of, substances to be used in medicine may be ascertained and determined." It is obvious that it cannot be an encyclopaedia of substances used in medicine, and can only be used as a standard for the substances and preparations contained in it, and for no others. It has been held in the Divisional Courts (Dickins v. Randerson) that the Pharmacopoeia is a standard for official preparations asked for under their pharmacopoeial name. But there are many substances in the Pharmacopoeia which are not only employed in medicine, but have other uses, such as sulphur, gum benzoin, tragacanth, gum arabic, ammonium carbonate, beeswax, oil of turpentine, linseed oil, and for these a commercial standard of purity as distinct from a medicinal one is needed, since the preparations used in medicine should be of the highest possible degree of purity obtainable, and this standard would be too high and too expensive for ordinary purposes. The use of trade synonyms in the Pharmacopoeia, such as saltpetre for purified potassium nitrate, and milk of sulphur for precipitated sulphur, is partly answerable for this difficulty, and has proved to be a mistake, since it affords ground for legal prosecution if a chemist sells a drug of ordinary commercial purity for trade purposes, instead of the purified preparation which is official in the Pharmacopoeia for medicinal use. This would not be the case if the trade synonym were omitted. For many drugs and chemicals not in the Pharmacopoeia there is no standard of purity that can be used under the Adulteration of Food and Drugs Act, and for these, as well as for the commercial quality of those drugs and essential oils which are also in the Pharmacopoeia, a legal standard of commercial purity is much needed. This subject formed the basis of discussion at several meetings of the Pharmaceutical Society, and the results have been embodied in a work entitled Suggested Standards for Foods and Drugs, by C. G. Moor, which indicates the average degree of purity of many drugs and chemicals used in the arts, as well as the highest degree of purity obtainable in commerce of those used in medicine.
Another legal difficulty connected with modern pharmacopoeias is the inclusion in some of them of synthetic chemical remedies, the processes for preparing which have been patented, whilst the substances are sold under trade-mark names such as verona. The scientific chemical name is often long and unwieldy, and the physician prefers when writing a prescription to use the shorter name under which it is sold by the patentees. In this case the pharmacist is compelled to use the more expensive patented article and the patient complains of the price. If he uses the same article under its pharmacopoeial name when the patented article is prescribed s/he lays oneself open to prosecution by the patentee for infringement of patent rights. The only plan, therefore, is for the physician to use the chemical name (which cannot be patented) as given in the Pharmacopoeia, or for those synthetic remedies not included in the Pharmacopoeia, to use the scientific and chemical name given in the British Pharmaceutical Codex.
TRANSFORMATION
From new discoveries to developments, pharmacopoeia guides to technology, the interactions that occur between a living organism and exogenous chemicals that alter normal biochemical function. Substances with medicinal properties, are considered pharmaceuticals. The field encompasses drug composition and properties, interactions, toxicology, therapy, and medical applications and antipathogenic capabilities. A variety of topics involved with pharmacology, including neuropharmacology, renal pharmacology, human metabolism, intracellular metabolism, and intracellular regulation. Pharmacology is not synonymous with pharmacy, which is the name used for a profession, though in common usage the two terms are confused at times. Pharmacology deals with how drugs interact within biological systems to affect function. It is the study of drugs, of the body's reaction to drugs, the sources of drugs, their nature, and their properties. In contrast, pharmacy is a medical science concerned with the safe and effective use of medicines.
An origin of clinical pharmacology is in middle Ages in Avicenna's The Canon of Medicine, Peter of Spain's Commentary on Isaac, and John of St Amand's Commentary on the Antedotary of Nicholas. Pharmacology as a scientific discipline did not further advance until the mid-19th century amid the great biomedical resurgence of that period. Before the second half of the nineteenth century, the remarkable potency and specificity of the actions of drugs such as morphine, quinine and digitalis were explained vaguely and with reference to extraordinary chemical powers and affinities to certain organs or tissues. The first pharmacology department was set up by Buchheim in 1847, in recognition of the need to understand how therapeutic drugs and poisons produced their effects.
In the United States, the Food and Drug Administration (FDA) is responsible for creating guidelines for the approval and use of drugs. The FDA requires that all approved drugs fulfill two requirements:
1. The drug must be found to be effective against the disease for which it is seeking approval.
2. The drug must meet safety criteria by being subject to extensive animal and controlled human testing.
Gaining FDA approval usually takes several years to attain. Testing done on animals must be extensive and must include several species to help in the evaluation of both the effectiveness and toxicity of the drug. The dosage of any drug approved for use is intended to fall within a range in which the drug produces a therapeutic effect or desired outcome.
The safety and effectiveness of prescription drugs in the U.S. is regulated by the federal Prescription Drug Marketing Act of 1987.
The Medicines and Healthcare products Regulatory Agency (MHRA) has a similar role in the UK.
Early pharmacologists focused on natural substances, mainly plant extracts. Pharmacology developed in the 19th century as a biomedical science that applied the principles of scientific experimentation to therapeutic contexts.
The genetic revolution has pushed to the forefront a concept that is at the very heart of pharmacology and therapeutics – the right drug for the right target in the right patient and delivered at the right dose. In some areas such as cancer treatments, examples of specific tumour mutations that dictate the response to drugs is a reality. This will influence the nature of future clinical trials. The bigger challenge lies in understanding whether the same will be true for common germline genetic variation (polymorphisms) in the general population. Will common genetic variation influence response to treatment? The complexity of turning this into a clinically meaningful risk score is such that attention has turned towards pharmaceuticals. Is drug failure due in individual patients due to genetic variation? Could drug safety be improved by taking into account individual genetic risk? Data on genetic variation influencing efficacy are sparse.
On another level, by taking reductionism and integrated approaches, genetics and molecular pharmacology are beginning to unravel the enigmatic problem of drug receptor heterogeneity. The future promises new generations of drugs that could selectively target one subtype in a family of similar proteins to the therapeutic advantage of the patient while limiting commonly accepted and often debilitating side effects.
Pharmacology as a chemical science is practiced by pharmacologists. Viz.:
• Clinical pharmacology - the medical field of medication effects on humans
Clinical pharmacology connects the gap between medical practice and laboratory science. The main objective is to promote the safety of prescription, maximize the drug effects and minimize the side effects. It is important that there be association with pharmacists skilled in areas of drug information, medication safety and other aspects of pharmacy practice related to clinical pharmacology.
Clinical pharmacologists have a rigorous medical and scientific training which enables them to evaluate evidence and produce new data through well designed studies. Clinical pharmacologists have access to enough outpatients for clinical care, teaching and education, and research as well be supervised by medical specialists. Their responsibilities to patients include, but are not limited to analyzing adverse drug effects, therapeutics, and toxicology including reproductive toxicology, cardiovascular risks, perioperative drug management and psychopharmacology.
• Neuro- and psychopharmacology (effects of medication on behavior and nervous system functioning),
Neuro is a study a wide range of substances with various types of psychoactive properties. The professional and commercial fields of pharmacology and psychopharmacology do not mainly focus on psychedelic or recreational drugs, as the majority of studies are conducted for the development, study, and use of drugs for the modification of behavior and the alleviation of symptoms, particularly in the treatment of mental disorders (psychiatric medication). While studies are conducted on all psychoactives by both fields, psychopharmacology focuses primarily on the psychoactive and chemical interactions with the brain.
Psychoactive drugs may originate from natural sources such as plants and animals, or from artificial sources such as chemical synthesis in the laboratory. These drugs interact with particular target sites or receptors found in the nervous system to induce widespread changes in physiological or psychological functions.
• Pharmacogenetics (clinical testing of genetic variation that gives rise to differing response to drugs)
The terms pharmacogenomics and pharmacogenetics tend to be used interchangeably, and a precise, consensus definition of either remains elusive. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing response to drugs, while pharmacogenomics is the broader application of genomic technologies to new drug discovery and further characterization of older drugs.
• Pharmacogenomics (application of genomic technologies to new drug discovery and further characterization of older drugs)
Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. By doing so, pharmacogenomics aims to develop rational means to optimise drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Such approaches are advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup.
Pharmacogenomics is the whole genome application of pharmacogenetics, which examines the single gene interactions with drugs.
• Pharmacoepidemiology (study of effects of drugs in large numbers of people)
Pharmacoepidemiology borrows from both pharmacology and epidemiology. Thus, pharmacoepidemiology can be called a bridge science spanning both pharmacology and epidemiology. Pharmacology is the study of the effect of drugs and clinical pharmacology is the study of effect of drugs in humans. Part of the task of clinical pharmacology is to provide a risk benefit assessment for the effect of drugs in patients. Doing the studies needed to provide an estimate of the probability of beneficial effects in populations, or the probability of adverse effects in populations and other parameters relating to drug use may benefit from using epidemiological methodology. Pharmacoepidemiology then can also be defined as the application of epidemiological methods to pharmacological issues.
Pharmacoepidemiology benefits from the methodology developed in general epidemiology and may further develop them for applications of such methodology unique to pharmacoepidemiology. There are also some areas that are altogether unique to pharmacoepidemiology, e.g., pharmacovigilance. Pharmacovigilance is a type of continual monitoring for unwanted effects and other safety-related aspects of drugs that are already on the market. In practice, pharmacovigilance refers almost exclusively to the spontaneous reporting systems which allow health care professionals and others to report adverse drug reactions to a central agency. The central agency can then combine reports from many sources to produce a more informative safety profile for the drug product than could be done based on one or a few reports from one or a few health care professionals.
• Toxicology study of harmful effects of drugs
Study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people.
Theoretical pharmacology
Posology - how medicines are dosed
Pharmacognosy a branch of pharmacology dealing especially with the composition, use, and development of medicinal substances of biological origin and especially medicinal substances obtained from plants also known as deriving medicines from plants
PHARMA MACHINERY & EQUIPMENTS: BY PIYUSH TRIPATHI
MANUFACTURING
Manufacturing is the use of machines, tools and labor to make things for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be used for manufacturing other, more complex products, such as household appliances or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users - the "consumers".
Manufacturing takes place under all types of economic systems. In a free market economy, manufacturing is usually directed toward the mass production of products for sale to consumers at a profit. In a collectivist economy, manufacturing is more frequently directed by the state to supply a centrally planned economy. In free market economies, manufacturing occurs under some degree of government regulation.
Modern manufacturing includes all intermediate processes required for the production and integration of a product's components. Some industries, such as semiconductor and steel manufacturers use the term fabrication instead. The manufacturing sector is closely connected with engineering and industrial design. Pharmaceutical machinery manufactures have understood the concept behind the process involvement for development of drug, machinery are developed as per client process requirement. Need for such development required in-depth study and monitoring process requirements of clients. Machinery manufactures updated their facilities by latest automated machinery for manufacturing parts, in addition to this there are also other visible trends that can explain committed interest of Indian machinery manufacturers further:
- Manufactures are going for CNC machine to get quality output
- Use of efficient and modern gadgets in the machine, like, VFD, PLC etc.
- Quality approvals and Trademarks, getting ISO approval and international certificate approval for quality manufacturing are also a part of dedication.
- To adapt and implement prototype machines are imported by manufactures.
- Tie-up & Collaboration for technology transfer with international manufactures.
- Expanding high tech facility to meet rising global demand.
Indian Pharma Machinery Manufacturers Association (IPMMA) is also established to work as entrepreneur’s team and also sets technological fairs and international and domestic meet providing a platform for B to B meets and bringing client and manufacture directly in touch with each other and working for mutual benefit.
PHARMACEUTICAL MACHINERY SEGMENT
Industrial segment specially pharmaceutical process and packaging sector have adopted modern means of process evolvement, manufactures have upgraded and adapted modern means of process plant development for providing controlled economical and efficient setups to cope up with the up coming trend and technological advancements. In many production plants, pharmaceutical manufacturers have developed a high degree of automation. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets, or made into solutions. One type of machine, for example, automatically fills, seals, and stamps capsules. Other machines fill bottles with capsules, tablets, or liquids, and seal, label, and package the bottles.
At the time of industrialization growth flow in 60’s and 70’s the pharmaceutical industry big or small were forced to imported machines from Europe for their processing and packaging needs. During the phase entrepreneurs, engineers in India realized the need for development in the sector for better improvement and meeting requirements of the fastest growing Industry Pharmaceutical process and packing. After the declaration of industrial policies in the mid 70's Indian government introduced very high import duties and restrictive import licensing policies. This resulted in a spark in the Indian engineers to prove their excellence as enterprises to manufacture machines locally. Engineers had the skills and now the support of industry and associations were form to cater the domestic market for better improvement as perhaps the only route for the pharmaceutical industry to enhance production and cater to the growing demands of the domestic market.
With this big a size of the industry a proper setup development plan and skill to cater the need was inevitable. Pharmaceutical Industry grew at the most fastest rate in India for its mineral rich resources, ore availability, raw material power house of such basic ingredients which were cheaply available in local market strengthen the growth. To support the industry Pharmaceutical Machinery Manufactures also upgraded themselves and adapted to a marketing plan. To ensure proper flow and meeting technological upgrades manufactures had to plan a proper strategy for not only meeting requirements but also giving technological upgrade the equipments for faster and efficient working.
DOMESTIC MANUFACTURING CHALLENGES
The machinery manufacturing industry, like all international manufacturers, continues to evolve. Domestic and foreign competition has required the industry to adopt new technologies and techniques to lower costs and raise the productivity of its workforce. For example, using high-technology production techniques, including robots, computers, and programmable equipment results in productivity gains and helps to maximize the use of available equipment and workers. Increasing technology and automation also reduces the number of unskilled workers needed in the production process.
Pressures to reduce costs and maximize profits have also caused manufacturers in the industry to adopt new business practices. One example is the practice of contracting out support functions, such as janitorial and security jobs, and increasingly some administrative services and warehouse and shipping jobs. Rather than employ workers directly for these jobs, a manufacturer will often contract with another company that specializes in providing these services. This practice reduces costs by forcing service providers to compete for the work, allows manufacturers to focus on their core design and production activities, and increases manufacturers’ flexibility by letting them add and subtract contract workers more easily than they could hire and fire employees.
These changes have had a profound effect on the machinery manufacturing workforce. By automating many of the production processes and outsourcing many of the administrative and support functions, it has reduced the need for many less skilled workers and increased the skill level required for the remaining workers. These changes are allowing the industry to remain competitive and meet the demand for machinery that other industries rely on.
One of the greater challenge faced is specialization in restricted field of work to set up a work force which requires, Engineers specialize in a particular facet of design. Mechanical engineers design the moving parts of the machine, such as the gears, levers, and pistons in engine and hydraulic systems. They also direct the work of mechanical engineering technicians, who run tests on materials and parts before they are assembled into the final product. For machines with complicated electric or electronic systems, electrical and electronics engineers also assist in the design and testing process. Industrial engineers determine how best to allocate the resources of the factory—both workers and equipment—for optimal production. Once a design is finished and simulation testing complete, mechanical drafters creates the plans that production workers use in the assembly of the machine. They provide specifications and diagrams for each part required, as well as assembly instructions for the final product. Computer control programmers and operators manage the automatic metalworking machines that can mass produce individual parts. They also write programs based upon the specifications of the part that defines what operation the machine should perform. Machinists produce precision parts that require particular skill or that are needed in quantities too small to require the use of automated machinery. Welding, soldering, and brazing workers operate machines that join two or more pieces of metal together; they may also weld manually as well.
Once all of the parts have been made, it is the responsibility of assemblers and fabricators to put them all together to finish the product. Some assemblers specialize in one particular stage of the process, while others, such as team assemblers, work as a group and may contribute to an entire subassembly process. While there has been increased automation of the assembly process, many parts of the products still have to be put together and fastened by hand. When assembly is complete, painting workers apply paint or a protective coating to the exterior of the machine.
While quality control is a responsibility of all production workers, it is the primary focus of inspectors, testers, samplers, and weighers. These workers monitor the entire production stage, making sure that individual parts, as well as the finished product, meet the standards set by the company.
In addition to production-specific occupations, this industry has various managers and administrative support personnel to handle functions such as human relations, accounting, and general management. The sales function for many companies is increasingly important. Sales representatives and sales engineers often work together to market the company’s machines to potential buyers, demonstrating how the machine may reduce costs or increase sales. They also explain how to operate the machine and answer buyer’s questions. Sales engineers in particular use their technical background to advise clients on how the machine can best be applied in their individual circumstances and to suggest custom designs or modifications to the equipment as needed.
MANAGEMENT ASPECT OF MANUFACTURING
The main factor affecting the level of employment in the machinery manufacturing industry is the high rate of productivity growth. Increases in productivity allow companies to produce more goods with the same number of workers. Even though output in machinery manufacturing is expected to increase significantly, firms are capable to meet the increase through higher productivity of existing workers, rather than by creating new jobs and increasing work force.
A second factor expected to cause some employment declines in machinery manufacturing is the growing number of imported parts. Earlier only raw material was available now finish part machined and finished are also available and raw material suppliers are supplying the same to compete with the competition. This industry is less likely to lose a large part of its output to imports from other countries than some other manufacturing industries. The large size and complexity of many of the types of machinery made by this industry and the relatively skilled workforce it requires is an advantage that many manufacturing industries do not share.
The manufacturing focus in the early-to-mid-2000s was on new and diverse products to meet the individual needs and desires of the market. Companies in 2003 wanted "quick changeover capabilities, flexibility, and fast speeds" more than any other features. Consequently, the industry was expecting continued growth to meet demands for newer and better packaging machinery, replacing older equipment with newer, faster, more efficient, and more automated machines. Trends toward lightweight, individually designed, flexible, and reusable packaging increased demand for the design of machines that could manufacture such packaging.
Demand for machinery is expected to remain strong. Machinery is important for all industries because it boosts their productivity, and advances in technology will make machinery even more efficient and thus more desirable. Demand for machinery is highly sensitive to cyclical swings in the economy, however, causing employment in machinery manufacturing to fluctuate. During periods of economic prosperity, companies invest in new equipment, such as machinery, in order to boost production. When economic growth slows, however, many companies are reluctant to purchase new machinery. These changes in demand cause machinery manufacturers to replace fewer workers who leave or even lay off some workers.
Although overall employment in the machinery manufacturing industry is expected to decline, the outlook for occupations will vary; some will experience larger declines than others, while some will even experience growth instead. Increased automation and more efficient production processes will cause employment declines in assembler and fabricator occupations. Office and administrative support workers will also experience declines as a result of increased automation and contracting out. Employment in professional and management occupations will experience smaller declines relative to other occupations in the industry; engineers in particular will experience very good employment opportunities, as they are responsible for increasing innovation and competitiveness in the industry.
USE OF PROCESS & PACKAGING MACHINERY
Primary use of process and packaging machinery is to elated equipment and it's uses.
BLENDING & MIXING
Blending is to combine or mix so that the constituent parts are indistinguishable from one another and to obtain a mixture of particular character, quality or consistency. Blending machines such as Agitators, Conical blenders, Continuous mixers, Dough mixers, Emulsifiers, Gas, Homogenizers, In line mixers, Meat mixers, Paste mixers, Plough blade, Powder mixers, Ribbon mixers, Solid phase mixers, Viscous product mixers, Z Blade mixers.
GRANULATORS
Current good manufacturing practices increasingly require that product is fully contained during processing to protect operators and environment. Integrated process systems not only offer containment but improved productivity through automation, increased yield and efficient cleaning procedures. The granulation process can be one of the following; Low shear dry granulation, high shear wet granulation and melt granulating. Mixing and granulating can be combined into one machine.
HOMOGENIZERS
Homogenizer is to reduce to particles and disperse throughout a fluid. Inline homogenizers are the ideal solution for continuous processing of emulsions and dispersions.
MILLING & SIEVING
The integration of all types of mills and sieves can be tailored to suit the individual needs. There can be specific applications such as hoist mounted systems and high powder containment levels. Other design options include nitrogen purge systems and CIP systems. Quick change over between products is essential and the application of integrated control systems is needed. There are various types of mills such as toothed colloid, corundum stone and perforated disc mills. Product is loaded via a hopper that can also be fitted with a feed screw, or via a pump. The milling zone is sealed by a single or double-acting mechanical seal, with no dead space. All product contact surfaces should be very easily cleaned with no need for dismantling (CIP). Thorough washing of all static seals during the cleaning process complies with the hygiene standards. In all industrial sectors, demands in terms of flexibility and hygiene management are constantly on the increase.
POWDER HANDLING
Common problems include material blockages where sticky poor flowing materials will not discharge from an IBC. Segregation of blended material is another common problem. Segregation can be caused during the discharge from the IBC. It can also occur after discharge from the IBC when product is allowed to fall through long chutes in free fall, and displaced air from below is forced back up the chute and separates the finer particles from the coarser particles.
PROCESS VESSELS
Processing vessels need to be of a high quality construction and are widely used by the food and processing industries. A selection of sizes, specifications and agitator combinations are available to suit most needs. Stainless steel is used for all fabricated parts to meet industry requirements. Pressurized jackets for heating by steam or water facilitate boiling, cooking, melting, dispersion and mixing of products. Vessels can also be equipped for oil heating or water cooling.
IBC / INDUSTRIAL BULK CONTAINER
Container blending has long been established as the most efficient method of blending granules and powders in the pharmaceutical manufacturing process. Reduced loading and unloading times, reduced cleaning time of both machinery and room, improved containment and batch integrity have established IBC blending as the pharmaceutical industry’s technology of choice.
PROCESS PUMPS
Various types of process pumps can be used depending upon the type of product to be moved between or within the complete process line of the various integrated sub systems. Pumps such as centrifugal, diaphragm, dosing, gear, metering, reciprocation and vacuum can be used. For example, vacuum pumps will be used for powder handling but screw metering drives can be used for more accurate powder movement.
PROCESS CLEANING MACHINES
The cleaning of the process machines will be mainly carried out by CIP (Clean In Place) systems. Depending on the sensitivity of the product being produced, the equipment may be cleaned aseptically and therefore eliminating any possible contamination from outside.
STERILIZING MACHINES
Sterilizing machines can also be called, Autoclaves and Retorts. There three main types of sterilizing system; static, rotary and pilot or laboratory systems.
GENERAL CHARACTERISTICS ARE:-
• Steam-Water sprays mix.
• Top shower for cans and glass jars plus side shower for pouches and trays
• Indirect cooling system by heat exchanger allows water recovery.
• All vessel, pipe work and valves and heat exchanger in stainless steel materials
• Insulated shell with mirror polished stainless steel cladding
• PLC control with modem connection allows remote troubleshooting and servicing
• Process monitoring in the operator interface with complete information of temperature, pressure, time and flow
• Easy product recipe setup with password protected access
• Optimum heat distribution (+/-0,5 ºC)
• Accurate pressure control (+/- 0,05 bar)
The rotary machines will use inverter drives for accurate control during the sterilizing process. There is also associated equipment such as basket trolleys and automatic loading systems available to fully automate the sterilizing process of product.
PROCESS CONTROL SYSTEMS
Compliance, traceability, consistency, and reliability of measurement data are primary concerns for the pharmaceutical industry. The control system is needed to verify the product quality through measuring, counting, inspection and testing of the manufacturing process. Operator input data; scanning systems and feedback systems are used.
PROCESS AND PACKAGING MACHINERY IN GENERAL
These machine types are very general indeed. Each area or sector of packaging equipment can be expanded upon to reveal the various applications that are available today. As technology advances, packaging machines are becoming more and more advanced to not only meet the current demands but to try and "future proof" the packaging equipment and product development within an organization. This can have a bearing on machine costs plus the interchangeability of operators and training. Packaging machines can be integrated into an existing line to enhance the production output or to reduce the labor and down type to pack the product. From single machine, to small systems or complete lines containing more than one new or existing / reconditioned packaging machine can be installed. Depending on the size of the installation, project process line and packaging machinery are available domestically to withstand & compete with market requirements.
Manufacturing is the use of machines, tools and labor to make things for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be used for manufacturing other, more complex products, such as household appliances or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users - the "consumers".
Manufacturing takes place under all types of economic systems. In a free market economy, manufacturing is usually directed toward the mass production of products for sale to consumers at a profit. In a collectivist economy, manufacturing is more frequently directed by the state to supply a centrally planned economy. In free market economies, manufacturing occurs under some degree of government regulation.
Modern manufacturing includes all intermediate processes required for the production and integration of a product's components. Some industries, such as semiconductor and steel manufacturers use the term fabrication instead. The manufacturing sector is closely connected with engineering and industrial design. Pharmaceutical machinery manufactures have understood the concept behind the process involvement for development of drug, machinery are developed as per client process requirement. Need for such development required in-depth study and monitoring process requirements of clients. Machinery manufactures updated their facilities by latest automated machinery for manufacturing parts, in addition to this there are also other visible trends that can explain committed interest of Indian machinery manufacturers further:
- Manufactures are going for CNC machine to get quality output
- Use of efficient and modern gadgets in the machine, like, VFD, PLC etc.
- Quality approvals and Trademarks, getting ISO approval and international certificate approval for quality manufacturing are also a part of dedication.
- To adapt and implement prototype machines are imported by manufactures.
- Tie-up & Collaboration for technology transfer with international manufactures.
- Expanding high tech facility to meet rising global demand.
Indian Pharma Machinery Manufacturers Association (IPMMA) is also established to work as entrepreneur’s team and also sets technological fairs and international and domestic meet providing a platform for B to B meets and bringing client and manufacture directly in touch with each other and working for mutual benefit.
PHARMACEUTICAL MACHINERY SEGMENT
Industrial segment specially pharmaceutical process and packaging sector have adopted modern means of process evolvement, manufactures have upgraded and adapted modern means of process plant development for providing controlled economical and efficient setups to cope up with the up coming trend and technological advancements. In many production plants, pharmaceutical manufacturers have developed a high degree of automation. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets, or made into solutions. One type of machine, for example, automatically fills, seals, and stamps capsules. Other machines fill bottles with capsules, tablets, or liquids, and seal, label, and package the bottles.
At the time of industrialization growth flow in 60’s and 70’s the pharmaceutical industry big or small were forced to imported machines from Europe for their processing and packaging needs. During the phase entrepreneurs, engineers in India realized the need for development in the sector for better improvement and meeting requirements of the fastest growing Industry Pharmaceutical process and packing. After the declaration of industrial policies in the mid 70's Indian government introduced very high import duties and restrictive import licensing policies. This resulted in a spark in the Indian engineers to prove their excellence as enterprises to manufacture machines locally. Engineers had the skills and now the support of industry and associations were form to cater the domestic market for better improvement as perhaps the only route for the pharmaceutical industry to enhance production and cater to the growing demands of the domestic market.
With this big a size of the industry a proper setup development plan and skill to cater the need was inevitable. Pharmaceutical Industry grew at the most fastest rate in India for its mineral rich resources, ore availability, raw material power house of such basic ingredients which were cheaply available in local market strengthen the growth. To support the industry Pharmaceutical Machinery Manufactures also upgraded themselves and adapted to a marketing plan. To ensure proper flow and meeting technological upgrades manufactures had to plan a proper strategy for not only meeting requirements but also giving technological upgrade the equipments for faster and efficient working.
DOMESTIC MANUFACTURING CHALLENGES
The machinery manufacturing industry, like all international manufacturers, continues to evolve. Domestic and foreign competition has required the industry to adopt new technologies and techniques to lower costs and raise the productivity of its workforce. For example, using high-technology production techniques, including robots, computers, and programmable equipment results in productivity gains and helps to maximize the use of available equipment and workers. Increasing technology and automation also reduces the number of unskilled workers needed in the production process.
Pressures to reduce costs and maximize profits have also caused manufacturers in the industry to adopt new business practices. One example is the practice of contracting out support functions, such as janitorial and security jobs, and increasingly some administrative services and warehouse and shipping jobs. Rather than employ workers directly for these jobs, a manufacturer will often contract with another company that specializes in providing these services. This practice reduces costs by forcing service providers to compete for the work, allows manufacturers to focus on their core design and production activities, and increases manufacturers’ flexibility by letting them add and subtract contract workers more easily than they could hire and fire employees.
These changes have had a profound effect on the machinery manufacturing workforce. By automating many of the production processes and outsourcing many of the administrative and support functions, it has reduced the need for many less skilled workers and increased the skill level required for the remaining workers. These changes are allowing the industry to remain competitive and meet the demand for machinery that other industries rely on.
One of the greater challenge faced is specialization in restricted field of work to set up a work force which requires, Engineers specialize in a particular facet of design. Mechanical engineers design the moving parts of the machine, such as the gears, levers, and pistons in engine and hydraulic systems. They also direct the work of mechanical engineering technicians, who run tests on materials and parts before they are assembled into the final product. For machines with complicated electric or electronic systems, electrical and electronics engineers also assist in the design and testing process. Industrial engineers determine how best to allocate the resources of the factory—both workers and equipment—for optimal production. Once a design is finished and simulation testing complete, mechanical drafters creates the plans that production workers use in the assembly of the machine. They provide specifications and diagrams for each part required, as well as assembly instructions for the final product. Computer control programmers and operators manage the automatic metalworking machines that can mass produce individual parts. They also write programs based upon the specifications of the part that defines what operation the machine should perform. Machinists produce precision parts that require particular skill or that are needed in quantities too small to require the use of automated machinery. Welding, soldering, and brazing workers operate machines that join two or more pieces of metal together; they may also weld manually as well.
Once all of the parts have been made, it is the responsibility of assemblers and fabricators to put them all together to finish the product. Some assemblers specialize in one particular stage of the process, while others, such as team assemblers, work as a group and may contribute to an entire subassembly process. While there has been increased automation of the assembly process, many parts of the products still have to be put together and fastened by hand. When assembly is complete, painting workers apply paint or a protective coating to the exterior of the machine.
While quality control is a responsibility of all production workers, it is the primary focus of inspectors, testers, samplers, and weighers. These workers monitor the entire production stage, making sure that individual parts, as well as the finished product, meet the standards set by the company.
In addition to production-specific occupations, this industry has various managers and administrative support personnel to handle functions such as human relations, accounting, and general management. The sales function for many companies is increasingly important. Sales representatives and sales engineers often work together to market the company’s machines to potential buyers, demonstrating how the machine may reduce costs or increase sales. They also explain how to operate the machine and answer buyer’s questions. Sales engineers in particular use their technical background to advise clients on how the machine can best be applied in their individual circumstances and to suggest custom designs or modifications to the equipment as needed.
MANAGEMENT ASPECT OF MANUFACTURING
The main factor affecting the level of employment in the machinery manufacturing industry is the high rate of productivity growth. Increases in productivity allow companies to produce more goods with the same number of workers. Even though output in machinery manufacturing is expected to increase significantly, firms are capable to meet the increase through higher productivity of existing workers, rather than by creating new jobs and increasing work force.
A second factor expected to cause some employment declines in machinery manufacturing is the growing number of imported parts. Earlier only raw material was available now finish part machined and finished are also available and raw material suppliers are supplying the same to compete with the competition. This industry is less likely to lose a large part of its output to imports from other countries than some other manufacturing industries. The large size and complexity of many of the types of machinery made by this industry and the relatively skilled workforce it requires is an advantage that many manufacturing industries do not share.
The manufacturing focus in the early-to-mid-2000s was on new and diverse products to meet the individual needs and desires of the market. Companies in 2003 wanted "quick changeover capabilities, flexibility, and fast speeds" more than any other features. Consequently, the industry was expecting continued growth to meet demands for newer and better packaging machinery, replacing older equipment with newer, faster, more efficient, and more automated machines. Trends toward lightweight, individually designed, flexible, and reusable packaging increased demand for the design of machines that could manufacture such packaging.
Demand for machinery is expected to remain strong. Machinery is important for all industries because it boosts their productivity, and advances in technology will make machinery even more efficient and thus more desirable. Demand for machinery is highly sensitive to cyclical swings in the economy, however, causing employment in machinery manufacturing to fluctuate. During periods of economic prosperity, companies invest in new equipment, such as machinery, in order to boost production. When economic growth slows, however, many companies are reluctant to purchase new machinery. These changes in demand cause machinery manufacturers to replace fewer workers who leave or even lay off some workers.
Although overall employment in the machinery manufacturing industry is expected to decline, the outlook for occupations will vary; some will experience larger declines than others, while some will even experience growth instead. Increased automation and more efficient production processes will cause employment declines in assembler and fabricator occupations. Office and administrative support workers will also experience declines as a result of increased automation and contracting out. Employment in professional and management occupations will experience smaller declines relative to other occupations in the industry; engineers in particular will experience very good employment opportunities, as they are responsible for increasing innovation and competitiveness in the industry.
USE OF PROCESS & PACKAGING MACHINERY
Primary use of process and packaging machinery is to elated equipment and it's uses.
BLENDING & MIXING
Blending is to combine or mix so that the constituent parts are indistinguishable from one another and to obtain a mixture of particular character, quality or consistency. Blending machines such as Agitators, Conical blenders, Continuous mixers, Dough mixers, Emulsifiers, Gas, Homogenizers, In line mixers, Meat mixers, Paste mixers, Plough blade, Powder mixers, Ribbon mixers, Solid phase mixers, Viscous product mixers, Z Blade mixers.
GRANULATORS
Current good manufacturing practices increasingly require that product is fully contained during processing to protect operators and environment. Integrated process systems not only offer containment but improved productivity through automation, increased yield and efficient cleaning procedures. The granulation process can be one of the following; Low shear dry granulation, high shear wet granulation and melt granulating. Mixing and granulating can be combined into one machine.
HOMOGENIZERS
Homogenizer is to reduce to particles and disperse throughout a fluid. Inline homogenizers are the ideal solution for continuous processing of emulsions and dispersions.
MILLING & SIEVING
The integration of all types of mills and sieves can be tailored to suit the individual needs. There can be specific applications such as hoist mounted systems and high powder containment levels. Other design options include nitrogen purge systems and CIP systems. Quick change over between products is essential and the application of integrated control systems is needed. There are various types of mills such as toothed colloid, corundum stone and perforated disc mills. Product is loaded via a hopper that can also be fitted with a feed screw, or via a pump. The milling zone is sealed by a single or double-acting mechanical seal, with no dead space. All product contact surfaces should be very easily cleaned with no need for dismantling (CIP). Thorough washing of all static seals during the cleaning process complies with the hygiene standards. In all industrial sectors, demands in terms of flexibility and hygiene management are constantly on the increase.
POWDER HANDLING
Common problems include material blockages where sticky poor flowing materials will not discharge from an IBC. Segregation of blended material is another common problem. Segregation can be caused during the discharge from the IBC. It can also occur after discharge from the IBC when product is allowed to fall through long chutes in free fall, and displaced air from below is forced back up the chute and separates the finer particles from the coarser particles.
PROCESS VESSELS
Processing vessels need to be of a high quality construction and are widely used by the food and processing industries. A selection of sizes, specifications and agitator combinations are available to suit most needs. Stainless steel is used for all fabricated parts to meet industry requirements. Pressurized jackets for heating by steam or water facilitate boiling, cooking, melting, dispersion and mixing of products. Vessels can also be equipped for oil heating or water cooling.
IBC / INDUSTRIAL BULK CONTAINER
Container blending has long been established as the most efficient method of blending granules and powders in the pharmaceutical manufacturing process. Reduced loading and unloading times, reduced cleaning time of both machinery and room, improved containment and batch integrity have established IBC blending as the pharmaceutical industry’s technology of choice.
PROCESS PUMPS
Various types of process pumps can be used depending upon the type of product to be moved between or within the complete process line of the various integrated sub systems. Pumps such as centrifugal, diaphragm, dosing, gear, metering, reciprocation and vacuum can be used. For example, vacuum pumps will be used for powder handling but screw metering drives can be used for more accurate powder movement.
PROCESS CLEANING MACHINES
The cleaning of the process machines will be mainly carried out by CIP (Clean In Place) systems. Depending on the sensitivity of the product being produced, the equipment may be cleaned aseptically and therefore eliminating any possible contamination from outside.
STERILIZING MACHINES
Sterilizing machines can also be called, Autoclaves and Retorts. There three main types of sterilizing system; static, rotary and pilot or laboratory systems.
GENERAL CHARACTERISTICS ARE:-
• Steam-Water sprays mix.
• Top shower for cans and glass jars plus side shower for pouches and trays
• Indirect cooling system by heat exchanger allows water recovery.
• All vessel, pipe work and valves and heat exchanger in stainless steel materials
• Insulated shell with mirror polished stainless steel cladding
• PLC control with modem connection allows remote troubleshooting and servicing
• Process monitoring in the operator interface with complete information of temperature, pressure, time and flow
• Easy product recipe setup with password protected access
• Optimum heat distribution (+/-0,5 ºC)
• Accurate pressure control (+/- 0,05 bar)
The rotary machines will use inverter drives for accurate control during the sterilizing process. There is also associated equipment such as basket trolleys and automatic loading systems available to fully automate the sterilizing process of product.
PROCESS CONTROL SYSTEMS
Compliance, traceability, consistency, and reliability of measurement data are primary concerns for the pharmaceutical industry. The control system is needed to verify the product quality through measuring, counting, inspection and testing of the manufacturing process. Operator input data; scanning systems and feedback systems are used.
PROCESS AND PACKAGING MACHINERY IN GENERAL
These machine types are very general indeed. Each area or sector of packaging equipment can be expanded upon to reveal the various applications that are available today. As technology advances, packaging machines are becoming more and more advanced to not only meet the current demands but to try and "future proof" the packaging equipment and product development within an organization. This can have a bearing on machine costs plus the interchangeability of operators and training. Packaging machines can be integrated into an existing line to enhance the production output or to reduce the labor and down type to pack the product. From single machine, to small systems or complete lines containing more than one new or existing / reconditioned packaging machine can be installed. Depending on the size of the installation, project process line and packaging machinery are available domestically to withstand & compete with market requirements.
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