A PROJECT REPORT ON PFIZER

Worlds Largest Research Based Pharmaceutical Company

SUBMITTED TO: PROF DR MOHANA SUNDARAM

BY-ABHISHEK JAISWAL

COMPANY BACKGROUND AND PROFILE

Pfizer is worlds No 1 Research based pharmaceutical company Pfizer incorporated is global pharmaceutical company established in 1849 Ranked as number one in sales in the world Head Quarter in New York city One of the highest spenders in pharmaceutical R&D globally Diversified global health care portfolio: human, animal biologic, small molecule medicines and vaccines Pfizer has won several awards including that for the multinational pharmaceutical company of the year and the most respected MNC Headquarter in Mumbai(India) Over 2,300 employees State-of-the-art manufacturing facility at Thane, Maharashtra Pfizer Limited (India) has a turnover of US$ 165.86 million Six Pfizer brands feature among the Top 100 pharmaceutical brands in India. Few of Pfizer brands - Lipitor, Viagra, Corex and Becosules etc

DISTRIBUTION CHANNEL The distribution channel is spread across a wide network of people Who are involved in the distribution process of Pfizer. This network is represented in the following flow chart as follows:

MANUFACTURING UNIT

CFA (CARRYING & FORWARDING AGENT)

STOCKISTS

RETAILERS

SEMI-STOCKIST

DISPENSING DOCTORS

END CONSUMERS

Pfizer adopts the above mentioned distribution channel to make their products reach the end consumer. Initially, the goods are manufactured and are passed on to the CFA, which is an external player who forwards the goods to the Pfizer stockiest and works on a margin basis. Pfizer follows an advance cheque system for delivery of goods. Further, the goods are sent to the retailers, semi-stockiest and the dispensing doctors. Semi-stockiest are those stockiest which are not

Pfizer official stockiest. The doctors who dispense medicines by their own are known as dispensing doctors. Through these people the goods reach the end consumer. Procurement Quality control Purpose: The purpose of Pfizer procurement is to achieve its objectives of creating highly valued medicines that improve health and quality of life. This also ensures consistent and sustained growth of the company. Mission: The main and ultimate purpose of Procurement department is to focus on driving high quality resource management decisions. This can be achieved through: Fast execution of key business processes Ensuring accuracy, transparency and awareness Develop strategies for business increase productivity and profitability Pfizer has a strong intra department network which helps to accomplished this task with various divisions in the company. The supplier can be existing, new or potential, but all have to abide the procurement guidelines, philosophy, of the organization and follow the strict guidelines framed by the quality managers of the company. An effective procurement is achieved by careful planning and maintaining stringent control on sensitive drugs which are costly and potent. To achieve this, company has followed these specific guidelines: Strategic Sourcing The process of strategic sourcing is based on flexibility of choices, improvement of the process and sharing of best practices within the organization. All the suppliers are given chance to prove their quality and cost effectiveness by the company and the top managers decides the best among them. Pfizer, then puts efforts to support and implement team efforts with the suppliers. This involves giving them information about the supply chain, knowledge about the pharmaceutical industrys economics, composition and current positioning with context to the requirement of the company. This also helps the organization and the its key business supplier, to understand the industry trends and be the first movers in adopting new emerging technologies, maintain consistent quality by studying the best practices in the industry. By using proper strategic sourcing tools and processes, Pfizer provides value to the business as well as saves a considerable amount of its costs. This ensures better supplier performance, higher quality of goods and services delivered. It also improves the total management process of the suppliers.

 Business process and technology Pfizer uses the Ariba Buyer and eForm tool in order to enable the client community of the organization to process requisitions faster and order catalog items directly. This also helps implementation of on-line approvals automated policy and procedure compliance. This has lead to enhanced access to management for data analysis. Collaborations across Pfizer division All the Pfizer units mentioned are in collaboration with each other and follow the global guidelines of the company strategies helping the organization to implement sourcing strategies, policies, and talent exchange for the benefit of the organization. This collaboration helps Pfizer to achieve its leadership goals, team initiatives and participation with its clients and suppliers giving Pfizer a competitive advantage and also enables it to produce new quality medicines to patients. Pfizer is helped by United Nations various health programs and in providing assistance by these organizations. Supplier diversity Pfizer encourages an environment of diverse suppliers in order to give equal opportunities to minority-owned business enterprises, women-based enterprises and small businesses. By enforcing supplier diversity, Pfizer encourages small enterprises to get associated with larger market and to come up to the international standards and guidelines of the pharmaceutical company. SUPPLIER QUALITY MANGEMENT These days supplier quality management has reached a high level of importance in all kinds of industries; computers and automobiles to name a few. It reduces production cost and increases efficiency and productivity in these industries. However, supplier quality management is unique for pharmaceutical and medical industries. This is primarily because pharmaceutical industry has to comply with strict product and process quality norms. So in order to maintain product quality and continue to stay competitive in the industry, Pfizer has adopted an efficient quality management system so as to ensure that supplier is integrated as a part of the manufacturing department and it is not considered as an outside entry. Supplier quality is closely related to the final quality of the product and the integrity of the company. The company carries all quality information about its suppliers and if there is a quality problem then as a part of their vision and mission the supplier is assisted and is identified with the problem and reasons. Monitoring quality of the component at source Monitoring the procurements is a vital stage in quality management of Pfizer

regularly inspects its suppliers and keep a inspection record of every. The supplier data is checked by internal audits of the company. More recently, Pfizer is using a web-based system which saves the entire process time. This improves the process quality by allowing its own supplier-quality team to do a direct inspection of the supplier by directly giving him time and date of the inspection Such a system can decrease the time for making decisions in quality processes and closely monitor quality of the suppliers. Such an efficient system of monitoring quality component at source reduces internal re-testing of the raw materials, which saves time as well as cost for the organization. Managing quality issues and taking corrective actions Under the Pfizer procurement guidelines, suppliers keep track of components that are not conforming to the specific quality standards. This information is immediately made available to the manufacturing department of the supplier, where it is reviewed and a root cause is identified. Accordingly action is taken. Also measures are taken to prevent recurrence of such non-conformance. This helps Pfizer to address and handle significant quality problems. These records are regularly checked by the Pfizer inspection team when they revisit the supplier factory. Audits of suppliers Supplier audits are an integral part of supplier management for Pfizer. Suppliers of Pfizer are regularly audit to improve quality control of raw materials received under supplier certification or certificate of compliance with specifications. Pfizer believes that audits are done to achieve continuous improvement. Postaudit activities are closely planned and discussed with the supplier in order to achieve meaningful results after the audits are completed. The results and issues arising from the audits are discussed with the suppliers. In case the supplier fails to meet the company norms the supplier is given warning and in worst conditions blacklisted. Measuring supplier performance Pfizer uses a supplier quality management system which enables manufacturers to differentiate top-performing suppliers from those that are under performing. This helps the organization to identify and choose the best supplier it wants to work with. The system helps to detect the number of defects, responsiveness, performance, quality of investigation, quality deviation etc of a particular supplier. In this manner Pfizer ensures to introduce discipline into the business by managing its quality in an effective manner.

DATA QUALITY MANAGEMENT IN PFIZER Quality management plays a very important role in Pfizer. Pfizer completely understands the value for life; hence, it ensures that drugs, medicines and injections are completely safe and effective when people consume them. Since

it is a matter of health and life, Pfizer does not compromise on the quality standards of the various drugs and other health related products that it develops and manufactures. To ensure that products are safe and effective, manufacturing processes are subject to strict legal conditions. National and international authorities constantly check and monitor whether the manufacturers are strictly adhering to quality regulations. This helps the company follow quality requirements and meet standards in development of its products as well as in maintaining mixers and packing lines. There are many software applications that can enable easy and convenient flow of information among various departments in a company, like production, sales and marketing, finance and accounting. But this does not always fulfill the quality requirements in terms of quality assurance and materials management. Hence Pfizer uses a software application known as Pharma Navigator, which is based on mySAP.com. This software application helps the organization to manage its key business processes by meeting specific quality requirements and standards. With the help of this software application, every product of Pfizer is taken through different stages of the quality control process. All the base materials are subjected to detailed laboratory analysis. Various tests are done at each production stage through to the final checks and verifications. These tests and checks help to check that the content of the drugs and injections conform to the manufacturing specifications. All manufacturing, research and development processes like logistics management, production and quality control are tracked with the help of MySAP.com. Pfizer ensures all its products right from the production to the shipment are completely transparent and with accordance with the FDA guidelines. When the company receives orders, it becomes easy to check the batches available, also their quantities and quality required. This industry solution helps Pfizer analyze and manage the quality of its products. The system ensures total quality control in the production of medications and sample materials like injections, vaccines, tablets and capsules. Pharma Navigator also helps in fast processing of faulty batches and residual stocks, which in turn provides useful information on recyclable residual stocks to the production controller. This helps reduce the amount of waste materials and unwanted inventory stocks. During the recent years, we have seen that Pfizer has significantly improved in its quality control system. The company has to done a significant development in getting all the mandatory and the quality control system to get update with the latest trend of the changing regulations and licenses by the pharmaceutical authorities such as Food and Drug Administration (FDA). Some of the technologies, certifications and quality system adopted are as follows: ISO 9000 series Process Analytical Technology (PAT) Applications of ISO 13485

 Risk assessment and Hazard Analysis Critical Control Point systems ISO 14000 for environmental control ISO 14971 for quality system Pharmaceutical current Good Manufacturing Practices (cGMP)for 21st centaury Use of design for Six Sigma in reducing risk and improving quality OSHAS for Occupational Health and Safety award The aim was to comply with all the regulations of pharmaceutical quality for veterinary and human drugs and human biological products such as vaccines. As part of CGMP guidelines, pharmaceutical as well as the chemistry, manufacturing, and controls (CMC) programs were successfully implemented with the following objectives: Encourage the early adoption of new technological advances by the company. Facilitate industry application of modern quality of management techniques, including implementation of quality systems. Encourage implementation of risk-based approaches that focus both industry and company attention on critical areas. Ensure that regulatory review, compliance, and inspection policies are based on FDA and pharmaceutical guidelines. Enhance the consistency and coordination of Pfizer drug quality control programs by further integrating enhanced quality systems approaches into the business processes and implementing policies related to inspection activities. To achieve this, a number of working groups were formed by the company, comprising FDA experts from various areas of scientific and regulatory practice. These working groups have shaped the company to meet the challenges in the new arena of the pharmaceutical industry by competing successfully with the competitors and to provide satisfaction to the customers by giving the best at affordable price. Thus the current good manufacturing practice (CGMP) has let Pfizer to achieve new goals and targets which earlier seems to be very challenging to achieve. As a result of the diligent work of these groups, Pfizer has completed its assessment of the existing CGMP programs. Now the company follows current practices as well as available new tools of enhancing manufacturing science. It has helped the company to create a new framework for manufacturing quality that is based on quality systems and risk management approaches. This has lead to the following achievements: Risk-based orientation: As the company has a huge network and is in every field of pharmaceutical sciences whether manufacturing APIs, clinical trials, adaptation of CGMP has lead to develop a better calculated method to minimize risk taken in new ventures and techniques in the field of pharmaceutical sciences. Efficient risk management has lead to the best use of scientific data, developing

quality standards, and using efficient systems and practices that provide clear and consistent decisions and communications for the public and regulated industry. Thus Pfizer was able to identify risk as a part of the CGMP program. The company now possesses highly educated and well-trained and integrated team of individuals who use risk-based and standard science-based approaches for making decisions in the entire life-cycle of a product. The company is able to create a framework that will allow to use their valuable resources in a more efficient manner and to minimize the risks to the public health associated with pharmaceutical product manufacturing. Science-Based Regulation of Product Quality One of the main areas of concern in the company after the certification was awarded was to comply with the strict standards mentioned in them. The guidelines were directed towards the decision making staff of the company which by using a statistical thinking approach were able to achieve essential improvements in Pfizer products, services, processes and environment matters. The company was successfully able to follow the Kaizen approach, a Japanese concept of approach to continuous improvement. Kaizen means on going improvement involving everyone right from the top management, to the managers and the workers. As pharmaceutical manufacturing evolves from an art to a science and engineering based activity, application of these components of total quality management has enhanced science and engineering knowledge of Pfizer in decision-making, establishment of specifications, efficiency and effectiveness for evaluation of manufacturing processes, policies and standards. Because the public is the ultimate customer of pharmaceutical manufacturing and is often unable to judge the quality of a product so by following Kaizen, the product quality was improved significantly and the patients do not have to worry about the quality of their medicines. Following the new TQM tools in the system has encourage the implementation of new technologies, such as process analytical technology (PAT), and facilitate continuous manufacturing improvements by implementation of an effective quality system. Thus Pfizer was able to control Data Analysis for manufacturing of its products such as tablets, capsules and other dosage forms and aseptic Processing Guidance for manufacturing of its parenterals (injections and other sterile medicines) and able to follow the strict guidelines mentioned in the certifications. Quality and productivity improvement has lead the company to increase its production by understanding better applications through manufacturing thus reducing the variation during manufacturing. Reducing variability provides a win-win opportunity from both public health and industry perspectives by facilitating improvements provide opportunities for both sectors of the pharmaceutical industry and meeting the challenges for the 21st century.

International Collaborations: In the pharmaceutical field a big company is not a superior company in all quality aspects. Pfizer was able to understand the need of mergers and collaborations. As a result a significant percentage of their manufacturing is licensed by third party. Under the strict guidelines of Pfizer, these companies manufacture Pfizer drugs with same quality and standards as Pfizer. The company is able to build an integrated quality system within and outside its departments. As a result the company showed steep rise in its recognition in the international environment and gained strong public health protection. They are committed with their partners to identify, develop and commercialize products that will not only bring key values for the company but also will the standards of life of the needy one across the world. Pfizer has been very successful in attracting and developing partnerships as core business activities and expects licensed products to contribute to their aggressive growth targets. Pfizer has increased its collaboration with international health and regulatory partners like OSHAS, FDA etc. Working together with international regulatory authorities have continued to harmonize activities related to health and research, especially in quality areas and has increased the sharing of information for the discovery of new medicines in the field of clinical trials in which the new combinations of medicines are tested for better result with synergistic effect and low side effects. Sharing and harmonizing scientific standards and assessments of drug product quality have lead to the new product innovation, enhancing public health safety and protection. Implementing the Future of Pharmaceutical Manufacturing Techniques: Pfizer is successfully able to regulate pharmaceutical manufacturing to ensure efficient drug supply in different parts of the world of high quality. In the past, as a result of the many uncertainties in drug manufacturing, Pfizer by adopting the ISO, OSHAS and CGMP exercised extensive control over virtually every aspect of the manufacturing process. Pfizer is seeking membership in the Pharmaceutical Inspection Cooperation Scheme (PICS), a cooperative arrangement among health authorities like FDA whose purpose is to provide platform for international development, implementation, and maintenance of harmonized CGMP standards and quality in all the plants of Pfizer situated world-wide. JIT Adoption: Among the component of TQM is the Just-in- time tool for quality management. It was seen earlier that the company was often reluctant to change their manufacturing processes and equipment because standard operating procedures made by them but in recent years, significant advances in manufacturing science, quality management systems, and risk management have taken place, yielding modern manufacturing tools that has helped to ensure manufacturing quality. The JIT concept followed by the company has lead to a strong interrelationship between the employers and the employees

 Empowerment Cross-training Training support Such new components of TQM has enable Pfizer to detect, analyze, correct, and prevent problems not only in its manufacturing processes but in matters related to procurement and packaging by making use of the modern tools, to facilitate the implementation of robust manufacturing processes to produce pharmaceuticals of high quality within a short period of time and to achieve economies of scale in its manufacturing processes. Processing Guidance Pfizer by implementing PAT for sterile dosage forms are products that are free from any bacterial or virus contaminations and controlled processing guidelines are followed to develop these products. These include various vaccines and drugs that are implanted on the body such as insulin patches. Thus by following the strict quality into products in equipments used, process, and system design for sterile drug manufacture. There are basically two requirements under this for parenterals (sterile medicines): Ensure robust product protection through adequate design and control of equipment and facilities. Ensure that all the raw materials are passed through adequate quality control and quality assurance tests. One of the main component which has lead Pfizer to increase its hold on quality is the SPC- Statistical Process Control or the 6 sigma control, aims in finding data from the industrial processes followed by Pfizer. Various SPC committees were set up by Pfizer which target sampling process capability and target processes that lead to continual improvement and eliminating waste which is the main objective of a pharmaceutical company. Through this guidance Pfizer is able to facilitate the application of good science and modern technology, and have reduced avoidable risks from aseptic operations. Thus the adoption of better contamination prevention practices reduces the incidence of sterile drug manufacturing problems. The guidance also encourages use of modern microbiological testing methods that are more accurate and precise. Personnel safety, environmental control, better drug designing can be carried out during manufacturing operation. Innovation in manufacturing Continuous improvement is an essential element in a modern quality system. Many new technologies are currently available to the company that provide information on physical, chemical, (micro) biological drugs to improve process understanding and to measure, control, and to have a proactive approach and predict quality and performance. The guidance facilitates the introduction of such new technologies to improve efficiency and effectiveness of manufacturing process design and control and quality assurance.

By improving the efficiency by optimizing a process and eliminating wasted efforts in production, has put a check on negative externalities. Thus without changing the fundamental design of a manufacturing process variability in a process and product quality was achieved by the company. Manufacturing based on Innovation and Continuous Improvement in Pharmaceutical Product Development has lead to the following achievements by the company. Preventing rejects, scrap, and re-processing Reducing operation time Increasing automation to improve operator safety and reduce human errors Improving energy and material use and increasing capacity Facilitating continuous processing to improve efficiency and better management Develop additional guidance on quality systems for pharmaceutical manufacturing to enhance and modernize pharmaceutical manufacturing and product quality is met. Correct implementation of CGMPs and meet internal and international goals. Continuous effective communication and compliance with FDA requirements.

BENCHMARKING
It has become a important component of TQM to strive in a world becoming more competitive and striving for world-class performance. Good enough is not enough. Pfizer is no doubt a leading Pharmaceutical company in the world. However, it is still struggling in many areas such as clinical trials and generation of further safety by its new products. The most primary requirement of a drug for the user is its safety and cost. ISO 9000 series is no doubt has played a major role in late nineties to improve quality to the company but now the new 2000 series and ISO 13485 should be taken into major considerations in framing future strategies of the company. Pfizer is having a major competition in neuroleptics (drugs curing nervous system) from big companies like Glaxo Smith Kline, Cipla and Novartis and Ranbaxy. These companies are able to capture a significant market in developing countries like India and in Asian sub-continent. The next decade is very challenging for the company. As the number of companies have increase in USA, Europe and Asia it will be tough for Pfizer to maintain its leadership image in the pharmaceutical market. INO Therapeutics is a multinational pharmaceutical company specializing in development of late-stage drugs and quality management system processes. The company's INOmax is the only pharmaceutical vasodilator approved by the FDA for treatment of persistent pulmonary hypertension in the newborn a disease in which there is irregular blood flow to the lungs and heart. Cipla, another pharmaceutical giant is continuously growing at a rapid rate and is a major treat to Pfizer. Today in this world the most dreadful disease is the

HIV/AIDS and Cipla and Glaxo SmithKline are the companies whose medicines are approved under the United Nations guidelines. Pfizer need to build up a strong R & D team in order to enter the huge market of AIDS and to remain at competition with the existing leaders. Pfizer should share best practices and benchmark strategies for better risk management with their counterparts and other major organizations such as Eli Lilly, Novartis and Biolex. Total Quality Management by Pfizer has lead to attain new heights within a short time to learn new methodologies for clinical trials and analysis from experts and industry leaders. It has developed standards for product quality initiatives that can stand in the competitive environment in capsules and tablets as they constitute the bulk manufacturing products of the company. Follow the cGMPs and all the necessary certifications and guidelines to maintain full compliance with the Pharmaceutical regulating authorities regulatory. Initiate workshop training and scholarship programes to the university students who are working in the field of curing diseases like cancer, HIV and bird flue. One of the recommendations highly suggested is to provide Job training to Ensure Manufacturing Quality, Product quality and the accuracy during manufacturing highly depends upon the employees of the manufacturing department and the batches in process are at risk when employees are inadequately prepared for their work and duties. Employees need skills, knowledge, experience, and behaviors in order to meet high production demands. Interactive workshop will be able to share their experiences and best practices and learn how to: Build effective work instructions and documentation that support production Teach the knowledge and significance of the various quality systems. Design and deliver consistency in job training to ensures competence in work after the training is completed Evaluate employees against the standards during and after training is completed

CONCLUSION
Pfizer started with a single product in fine chemicals and due to its constant innovation and maintenance of quality standard today it ranks first among the endless list of pharmaceutical companies in the world. It is the strict control of quality and the guidelines which they followed that resulted in their market leadership. Today Pfizer is a role model company having nearly all the prestigious

competitive awards under its belt and a huge network of offices worldwide striving continuously to achieve targets and providing health care around the world. Due to constant innovation and R&D, Pfizer is able to explore new molecules in biomedical sciences and it not only discovers rare drugs but also maintains quality standards during their procurement, manufacturing and packaging process. By following the various TQM components Pfizer is able to standardize their products, no matter wherever they are produced and marketed in the world. They are able to follow all the stringent quality control measures as their mission highlights constant healthcare for community benefits. Their extensive R&D has made them the leader in carrying out clinical trials for discovering safe quality drugs. Pfizer is no doubt the number one company in the world but still there are certain areas that needs to be improved especially in neuroleptics (brain medicines) and in developing HIV drugs because other companies like Cipla is still the pioneer in this field which has a huge market potential.

Working together for a healthier world

Thanks & Regards ABHISHEK JAISWAL SEC-A

JAN 2011-13