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.
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