PROJECT REPORT ON

TOTAL QUALITY MANAGEMENT IN PRODUCTION AT NESTOR PHARMACEUTICAL LTD."

Submitted in partial fulfillment for the degree of MASTER OF BUSINESS ADMINISTRATION (PHARMACEUTICAL MANAGEMENT)

Submitted By: PREETI (Enrollment no.-2012-542-025)

Under Guidance of: DR.RAVICHANDRAN HEAD OF THE DEPARTMENT SESSION 2012-2014

DEPARTMENT OF MANAGEMENT FMIT JAMIA HAMDARD NEW DELHI-110062

CERTIFICATE
This is to certify that Preeti, a Student of M.B.A. (Pharmaceutical Management), 2012-14 Batch, Jamia Hamdard has completed her Summer Internship Project titled Total Quality Management in Production at Nestor Pharmaceuticals in the given 45 days to the utmost satisfaction. She has always been dedicated and focused towards the fulfillment of the objectives of the project and its partial implementation, during her training tenure in the organization. She has always been regular in the reporting with the project related updates to us. She has submitted a satisfactory report of the same.

FACULTY SUPERVISOR: DR. RAVICHANDRAN (HEAD OF THE DEPARTMENT, FMIT) JAMIA HAMDARD

DECLARATION
I, undersigned declare that I, student of MBA (Pharmaceutical management) have undergone summer training on the topic quality management system in production is a bonafide work prepared in partial fulfillment for award of MBA (Pharmaceutical Management) degree under the supervision and guidance of Mr. Bharat Ram Kaushik, General Manager, Nestor Pharmaceuticals Ltd. I declare that prior to this I have not submitted this project to any Institution or University for any purpose.

Date: Sign: Place: MBA (Pharmaceutical Management)

Name: Preeti

ACKNOWLEDGMENT
This Project Report is the fruit of my intense hard work and dedication during my project work. I wish to express my sincere gratitude to my project supervisor

Mr. Bharat Ram Kaushik, General Manager, Nestor Pharmaceuticals Ltd. for his esteemed guidance during the course of project work. I am grateful to him for giving me an insight into the realm of topic of our project, invaluable guidance, thought provoking suggestions and excellent support throughout the course of our study, right from the selection of the topic and the study process. In spite of his busy schedule, he was always available whenever I required him. I would also like to thank my Faculty Supervisor, Dr. Ravichandran, Head of Department, FMIT, Jamia Hamdard for his constant support and valuable guidance during the tenure of this project. He has been a constant source of encouragement and was available I required his help.

PREETI M.B.A. (PHARMA MANAGEMENT) ENROLLNMENT NO.-2012-542-025 SESSION- 2012-14 SUMMER INTERN, NESTOR PHARMACEUTICALS LTD.

EXECUTIVE SUMMARY
Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Total Quality management is a crusade in Indian pharmaceutical industry and is one such approach along with government regulatory requirements that seeks to improve quality and performance in Pharmaceuticals which will meet or exceed customer expectations. An effective quality assurance policy with defined mission and objectives is the most important goal of pharmaceutical industry. Quality assurance and quality control together develops towards assuring the quality, safety and efficacy of pharmaceutical products. They should strive to achieve perfection by continuously improving the business and production processes. Thus, quality is critically important ingredient to organizational success, which can be achieved by total quality management TQM. It is an approach that arching goal, aimed at the prevention of defects rather than detection of defects.

1.INTRODUCTION
In five years, the world pharmaceutical market alone is poised to grow at a CAGR of 8% with business opportunities of over a trillion USD! USA, Japan and the European countries led by Germany shall remain the dominant markets controlling over 80% trade opportunities. Asian countries like South Korea, Taiwan and India are expected to have growth rates ranging from 12 to 15% annually. Advantage India needs to leverage its inherent strengths to its collective advantage. Areas would include productivity in drug discovery, production in terms of API and formulations besides becoming referral laboratories to identify questionable drug molecules. Cost competitive manufacturing base with a high number of internationally approved facilities World class skills in chemistry and process development Rapidly improving skill sets in biotechnology and drug discovery and development research Access to a large base of high calibre scientists and trained technical manpower Large number of providers of R&D, manufacturing and clinical trials outsourcing services India has roughly 7,000 pharma units, 35% of which (2,400) are registered manufacturers with Drug Controller General, India Ratio of API: Formulation units are 20:80. Only 300 units of these 7,000 are API units controlling 70% of Indias production facilities. Of these 300, only 80 units have the required US FDA approval albeit the highest outside the USA. Of these 80 units, only 10 units control 37% of the total Indian market ; 8 being Indian manufacturers. Since 1971, MNC share of Indian domestic trade has reduced to 35% while local players have progressively increased their presence to 65%. Indias export market is growing at a rate of 23%. Infrastructure in high-end manufacturing and testing facilities. Focused training per International standards and protocols for effective global presence.

The underlying opportunity lies in the fact that though Indian companies control 8% of the global volume (4th by world ranking) of business, it is merely 1% (13th by world ranking) in value terms.

Globalization and increasing domestic competition have brought a sense of urgency in inducting highly successful total quality management techniques in Indian pharmaceutical organizations. In the period before the 1950s, the onus of buying a good quality product was on the buyer himself, though this shifted towards a system of product warranty in sixties, when the manufacturers started taking, at least, limited responsibility for their products. This also started the advent of the statistical quality controls concept. In the 1970s quality became the cornerstone of Japan to make its industry competitive and it started producing high quality products. Later, by employing quality principles in controlling process waste, it was realized that quality could not be restricted any longer to a designated quality department, but it was to spread across the company, giving birth to the concept called "Total Quality Management" or TQM. TQM marks the beginning of new era, in which managers will focus on customer values, crossfunctional systems and continuous improvements. This report presents the basic ideas and components of TQM. The managerial skills required in the new environment and various techniques like benchmarking and business process re-engineering are also outlined.

2.REVIEW OF LITERATURE
Quality is never an accident. It is always the result of high intentions, sincere efforts, intelligent direction and skillful execution. It is an attribute or characteristic whose dictionary meaning is the degree of goodness or worth of a person, place or thing. In determining the quality of a product, the customer's expectations about the product will be given the top most priority. In the present scenario, customer delight is the need of the hour in order to survive the cutthroat competition. There are different approaches through which the concept of quality can be under stood. According to the product-based approach, quality is an attribute, which can be measured quantitatively. The manufacturing based approach on the other hand, uses universal definition of conformance to requirements. The value-based approach says that the consumer purchase decision is based on consistent quality at an affordable price.

2.1Definition of Quality
W. Edwards Deming defines quality as: "Pride in Workmanship" Dr. J. Juran defines quality as: "those product features which meet the needs of customers and thereby provide product satisfaction." or "freedom from deficiencies." Kaoru Ishikawa defines quality as: "total quality control, Japanese style, is a thought revolution in management." Gary Griffith, in his book "The Quality Technician's Handbook," defines quality as: "the totality of features and characteristics of a product or service that bear on its ability to satisfy given needs." Total Quality Management (TQM) Total Quality Management is a management approach that originated in the 1950's and has steadily become more popular since the early 1980's. Total Quality is a description of the culture, attitude and organization of a company that strives to provide customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company's operations, with processes being done right the first time and defects and waste eradicated from operations. Total Quality Management, TQM, is a method by which management and employees can become involved in the continuous improvement of the production of goods and services. It is a combination of quality and management tools aimed at increasing business and reducing losses

due to wasteful practices. Some of the companies, which have implemented TQM, include Ford Motor Company, Phillips Semiconductor, SGL Carbon, Motorola and Toyota Motor Company.

2.2 The TQM Concept

In this age of liberalization, the quality of products has become a major concern for pharma industries. To be competitive, an industry needs to provide a product/service, into which quality is designed, built, marketed and maintained at the most economical cost, which brings in customer "delight" instead of customer satisfaction. These competitive edges made the pharma industries think of approaching quality management efforts in their total form, known as Total Quality Management. The job of quality management is not just advising a sampling plan for the acceptance/ rejection of the incoming materials or products and controlling manufacturing process conditions. It is in fact a job at every stage of the company's activities. Quality Management is a companywide activity, involving the combined efforts of various departments such as R & D, engineering, purchase, production, Quality Control, Quality Assurance, Human Resources, Marketing, Distribution, Warehouse, etc in different phases with a view to achieve the desired quality of the end product. Quality awareness must begin at the very conception of the product and continue through various stages of development and manufacture & even during its use to get feedback from the users, which is essential for continuous product improvement.

2.3 TQM Defined

TQM is a management philosophy that seeks to integrate all organizational functions (marketing, finance, design, and engineering, and production, customer service) to focus on meeting customer needs and organizational objectives. TQM views an organization as a collection of processes. It maintains that organizations must strive to continuously improve these processes by incorporating the knowledge and experiences of workers. The simple objective of TQM is "Do the right things, right the first time, every time". TQM is infinitely variable and adaptable. Earlier, it was applied to manufacturing operations, and for a number of years were used only used in that area.

Now, TQM is becoming recognized as a generic management tool, just as applicable in service and public sector organization. Different sectors created different or their own versions from the common ancestor. TQM is the foundation for activities, which include: Commitment by senior management and all employees Meeting customer requirements Reducing development cycle times Just In Time/Demand Flow Manufacturing Improvement teams Reducing product and service costs Systems to facilitate improvement Line Management ownership Employee involvement and empowerment Recognition and celebration Challenging quantified goals and benchmarking Focus on processes / improvement plans Specific incorporation in strategic planning This shows that TQM must be practiced in all activities, by all personnel, in Manufacturing, Marketing, Engineering, R&D, Sales, Purchasing, HR, etc. TQM is a philosophy, which aims at managing a set of business practices that emphasizes continuous improvement in all phases of operations. It focuses of giving 100 percent accuracy in performing activities, involvement and empowerment of employees at all levels, team based work design, benchmarking and fully satisfying customer expectations. Quality improvement processes have now become a globally pervasive part of the fabric of implementing strategies keyed to defect-free manufacture, superior product quality, superior customer service, and total customer satisfaction. TQM entails creating a tool quality culture bent on continuously improving the performance of every task and value chain activity. In any TQM philosophy, aligning business processes to fulfill business objectives is the major exercise.

Functions/activities are performed to achieve business objectives. Departmental objectives are derived from business objectives. Activities are performed in the department to achieve departmental objectives. For each activity there is immediate internal or external customer and

supplier. It is necessary for every process owner to think about My Customers and What I provide to them and about My Suppliers and What They provide to me. It is necessary to identify major business process in the organization and measurement of process performance. TQM plays major role in successfully implementing business strategy. When TQM is not a part of wider scale effort to improve strategy execution and business performance, they deteriorate into strategy-blind efforts to manage better.

2.4 Principles of TQM

The key principles of TQM are as following: Management Commitment

1. Plan (drive, direct) 2. Do (deploy, support, and participate) 3. Check (review) 4. Act (recognizes, communicate, revise)

Employee Empowerment

1. Training 2. Suggestion scheme 3. Measurement and recognition 4. Excellence teams

Fact Based Decision Making

1. SPC (Statistical Process Control) 2. DOE (Design of Experiments), FMEA (Failure Modes and Effects analysis) 3. The 7 statistical tools 4. TOPS (FORD 8D - Team Oriented Problem Solving)

Continuous Improvement

1. Systematic measurement and focus on Cost of Non Quality (CONQ) 2. Excellence teams 3. Cross-functional process management

4. Attain, maintain, and improve standards Customer Focus

1. Supplier partnership 2. Service relationship with internal customers 3. Never compromise quality 4. Customer driven standards

2.5 What is the Philosophy of TQM?

Although no two businesses use TQM in exactly the same way, its theory rests on two basic tenets. The first and most important is that customers are vital to the operation of the organization. Without customers, there is no business, and without business, there is no organization. Consequently, it should be the primary aim of any group to keep customers satisfied by providing them with quality products (Deming 1986). These ideas are not foreign to most organizations. What makes TQM unique is its call for a restructuring of management methods to create that quality. TQM proponents urge organizations to turn nearsighted, top-down management "on its head" by involving both customers and employees in decisions. This second tenet, that management needs to listen to nontraditional sources of information in order to institute quality, is based on the belief that people want to do quality work and that they would do it if managers would listen to them and create a workplace based on their ideas (Deming). Managers, in the TQM view, need to become leaders who "not only work in the system but also on the system" (Rocheleau 1991). A company will see continuous improvement in products only when managers realize all systems consist of interdependent parts and work to aim all those parts toward a vision of quality. This type of leadership is needed to ensure that product quality improves constantly and forever and truly satisfies the customers (Deming).

2.6 The Concept of Continuous Improvement by TQM

TQM is mainly concerned with continuous improvement in all work, from high level strategic planning and decision-making, to detailed execution of work elements on the shop floor. It stems from the belief that mistakes can be avoided and defects can be prevented. It leads to continuously improving results, in all aspects of work, as a result of continuously improving

capabilities, people, processes, and technology and machine capabilities. Continuous improvement must deal not only with improving results, but also more importantly with improving capabilities to produce better results in the future. The five major areas of focus for capability improvement are demand generation, supply generation, technology, operations and people capability A central principle of TQM is that people may make mistakes, but most of them are caused, or at least permitted, by faulty systems and processes. This means that the root cause of such mistakes can be identified and eliminated, and repetition can be prevented by changing the process. There are three major mechanisms of prevention: 1. Preventing mistakes (defects) from occurring (Mistake - proofing or Poka-Yoke). 2. Where mistakes can't be absolutely prevented, detecting them early to prevent them being passed down the value added chain (Inspection at source or by the next operation). 3. Where mistakes recur, stopping production until the process can be corrected, to prevent the production of more defects. (Stop in time).

2.7 Implementation Principles and Processes

A preliminary step in TQM implementation is to assess the organization's current reality. Relevant preconditions have to do with the organization's history; its current needs, precipitating events leading to TQM, and the existing employee quality of working life. If the current reality does not include important preconditions, TQM implementation should be delayed until the organization is in a state in which TQM is likely to succeed. If an organization has a track record of effective responsiveness to the environment, and if it has been able to successfully change the way it operates when needed, TQM will be easier to implement. If an organization has been historically reactive and has no skill at improving its operating systems, there will be both employee skepticism and a lack of skilled change agents in that organization. If this condition prevails, a comprehensive program of management and leadership development should be instituted. A management audit is a good assessment tool to identify current levels of organizational functioning and areas in need of change. An organization should be basically healthy before beginning TQM. If it has significant problems such as a very unstable funding base, weak administrative systems, lack of managerial skill, or poor employee morale, TQM would not be appropriate.

However, a certain level of stress is probably desirable to initiate TQM. People need to feel a need for a change. Kanter (1983) addresses this phenomenon by describing building blocks, which are present in effective organizational change. These forces include departures from tradition, a crisis or galvanizing event, strategic decisions, individual "prime movers," and action vehicles. Departures from tradition are activities, usually at lower levels of the organization, which occur when entrepreneurs move outside the normal ways of operating to solve a problem. A crisis, if it is not too disabling, can also help create a sense of urgency, and can mobilize people to act. In the case of TQM, this may be a funding cut or threat, or demands from consumers or other stakeholders for improved quality of service. After a crisis, a leader may intervene strategically by articulating a new vision of the future to help the organization deal with it. A plan to implement TQM may be such a strategic decision. Such a leader may then become a prime mover, who takes charge in championing the new idea and showing others how it will help them get where they want to go. Finally, action vehicles are needed and mechanisms or structures to enable the change to occur and become institutionalized.

2.8Models of TQM
These models are presented in brief, because many of the concepts are already discussed above and these models have put different emphasis on some of these concepts. Only where some new point is brought in the model, it is discussed in details.

2.8.1. Seven characteristics of total quality by Feigenbaum

(i) Systematic Process, extending throughout the company. (ii) Quality process in the organization must be correctly structured. Else Everybodys job is Nobodys Job. (iii) Total Quality improvement must take place from Marketing to After Sales Service covering all aspects of the business. (iv) Emphasis on what buyer wants. (v) Application of new Technologies. (vi) Participation of ALL not just Specialists. (vii) Company must establish clear Customer Oriented Quality Management System, which people should understand and want to be part of.

2.8.2. The Integrated model of TQM

Figure: The Integrated Model of TQM In this model the Continuous Improvement is considered as the central mission of TQM.

4. Oaklands Model Figure: The Oakland Model on Total Quality Management

The Customer Supplier chains, both within and outside the organization are considered as central to TQM around which the other features are interwoven. Oaklands 13 states representing gradual progression towards implementation of TQM based culture: (i) Understanding Quality (ii) Commitment to Quality (iii) Policy on Quality (iv) Organization for Quality (v) Measuring Costs of Quality (vi) Planning for Quality (vii) Design for Quality (viii) System for Quality (ix) Capability for Quality (x) Control for Quality (xi) Team Work for Quality (xii) Training for Quality (xiii) Implementation of TQM

2.9 How does TQM Create an Environment that Promotes Quality?

TQM is more than just a philosophy. In addition to proposing new theories about the workplace, it advocates specific changes that managers need to make if they want to improve the system. These changes are best described in Deming's "14 Points," which are condensed under the four categories below: Customer Relationships: Customers can be either internal or external to an organization. Just as a customer is the person buying a product in a store, an employee is the customer of management. Managers need to realize that quality work will not be done unless they provide employees with quality products to work with (Blankstein 1992). Employee Empowerment: TQM starts at the top but should permeate the workplace the fact is that it will fail without employee involvement. Since workers know more about their jobs than management does, their input is vital to improving the system. It is a manager's responsibility to continuously train employees in the methods of TQM, involve them in

management decisions, listen to their suggestions for system changes, and work towards implementing those changes (Schmoker 1992). Continual Gathering and Use of Statistical Data: Most companies monitor the quality of their products by doing mass inspections that determine how many low-quality items are being produced, but Deming calls for monitoring of the production process by continually gathering statistical data so that problems can be identified as they are happening instead of when it is too late to solve them. When problems are identified, they should be the focus of discussion, and the groups discussing them should rely on the data to institute change instead of randomly assigning blame to individuals or departments (Deming). Create an Environment that Promotes Unity and Change: People need to feel comfortable discussing problems and suggesting solutions. Managers need to work at breaking down barriers between departments so that interactive discussion can take place. Fear must be eliminated. Also, managers are urged to do away with slogans, quotas, goals, and objectives since they encourage competition between workers and put the focus on individual results rather than process (Deming).

2.10 The TQM Vision

The quality cycle begins and ends with the user. It starts when the user's need is analyzed to design a product. During the development & manufacture of that product, various departments and sections of the company make their contributions in building quality into it. The cycle ends with the user because the final proof of the product quality comes during its use by the user, whose "delight" is the ultimate aim of this concept. Quality is no longer the exclusive domain of the inspectors, manufacturers and pharmacists. Even Sales personnel have their role to play in the achievement of the primary objective of quality. Quality Management, as does any management process, has three main components: 1. Quality Planning - Designing the desired & deliverable quality standards. 2. Quality Implementation. 3. Quality Monitoring & control. It is imperative that TQM efforts should be properly organized to co-ordinate the various contributing aspects of quality. As such we need to know the basic ideas behind TQM. Organizations are made up of a complex system of customers and suppliers. People pay attention

to who supplies them; with what they need to do their job and who the customer is for what they produce. When everybody becomes concerned about meeting their customers' requirements, quality will be there, without doubt. In meeting customer expectations the focus must be on the process, not just on the results. To improve a process it is important to look at the sociocultural issues of organization to create a healthy, open atmosphere in which people are willing to open up and do some introspection on their processes. And this is something the management must be able to facilitate. In contrast to traditionally managed organization, TQ managed organizations believe that, though there is no complaint from the customers, there is always scope for improvement. Everybody in the organization is trained to plan & participate in groups. Meetings & Brain storming sessions become primary vehicles for planning & creative problem solving. Each member in the team is recognized & rewarded. Errors and problems are viewed as opportunities for learning rather than blunders to be punished. In the recent past, TQM got its formal recognition by way of ISO 9000. In order that organizations may successfully compete with world-class leaders, it is imperative to look at and be prepared for quality way beyond the popular ISO 9000. In the context of the Indian organization, the common perception held is that quality improvement is uneconomical since it increases cost and investment, thereby decreasing productivity. Traditional Indian managers are not prepared for intense global competition where quality, cost, and sticking to the deadlines and customer satisfaction are of paramount importance. They are not prepared to shed the belief that they can get business by cornering licences, influencing the bureaucrats. Domestic managers are unaware of the momentous changes taking place. Ironically even today most Indian managers rely more on market gossip and collecting random data than paying an accredited agency for factual information. Indian companies should wake up to the realities and try to build up an organization where information flows freely; employees are empowered with decision-making and problem solving, where teamwork is awarded and encouraged. Our executives have to learn how to become successful quality managers, so that they can become global managers and this primarily means change in their mindset.

2.11 The key word here is "professionalism".

Many managers have trouble fully trusting their employees. It is not surprising that many new managers want to keep control firmly in their own hands, but TQ managers see their employees as a work group and believe that their team wants to do a good job. The manager must learn skills of collaboration. He is to make certain his team has had the correct training in the use of data and statistical tools. Management by fact is the main characteristic of TQ manager. He should also reward the deserving team or individual for their support of the TQM philosophy. Recognition and reward are his key tools and he has to know how to use them in order to support TQM. He should help employees to gain insights from their personal experiences and how to improve on them thereupon. Many companies in India are realizing this and are now focusing their efforts on team building and teamwork. Hindustan Lever Limited, a Unilever group company operating in India, started implementing quality assurance in place of Quality Control. Looking at the success of quality assurance, the company started TQM in 1990; mainly to focus on intensified broad based training at all levels, institutionalizing quality improvement programmes, vendor development & certification.

2.12 TQM Techniques Benchmarking: For many companies benchmarking has become a component of their TQM
Programme. In most developing countries like India, until recently almost all the industries had a few number of products and services, which differed markedly in their utilitarian characteristics. However, such a situation is hardly sustainable with increasing competition from foreign goods and services. In such a situation, competing firms have to continuously improve. The benchmarking approach not only provides a comparative profile, but also helps the management to identify innovative products and services. "Benchmarking is a continuous process of measuring one's products, services & practices against toughest competitors". It will search for the best practices in the industry, which will lead to superior quality goods. With the growing emphasis on quality, it has got great significance in the present competitive world. If best practices are followed, customer requirements can easily be met, leading to increasing profitability of the company. But the employees resist change in the beginning because they are habituated to old processes. Efforts to change mindset of employees must vigorously continue till desired effect is achieved.

Business Process Reengineering:

Business Process Reengineering generally redesigns processes & the organization that performs them in order to reduce the number of boundaries crossed. Each time a process crosses an organizational boundary, opportunities for errors arise. Business Process Reengineering is the fundamental rethinking and radical redesign of Business Processes to achieve dramatic improvements in critical contemporary measures of performance, such as cost, quality, service and speed.

Precautions:
Wherever the responsibility of quality management is to be delegated to different departments, it should be done with many precautionary measures, thereby ensuring monitoring & control is in the hands of quality management people. The hierarchy structure of quality management should be kept to as few levels as possible and the span of control should be as broad as possible. As the traditional organizations are unable to meet the present challenges, there is every need for new techniques & philosophies with which organizations can survive and thrive under grueling competition. To retain their competitive edge, company should change their traditional ways of working, to read their customer's mind. No organization can afford to overlook customer, competition & change, the three vital forces of today's competitive environment. TQM is an important milestone in the ongoing evolution of the field of management.

3 .OBJECTIVES OF THE STUDY

1. To study the Quality Control Procedures as adopted by Nestor pharmaceutical ltd. in India. 2. What are the quality tools and techniques at Nestor Pharmaceutical ltd?

3.1 RATIONALE FOR CHOOSING THE TOPIC

The area of study of this project is Total Quality Management. What has been done in this direction and how? It is proposed to be a study of Quality Control Process at Nestor Pharmaceutical ltd. It is not supposed to be a definite study of every facet of quality management but to try and trace how important it is in pharmaceutical industry and for that matter any field. One of the reasons for selecting this subject was to link theory with productivity and quality as implemented in industry. Managers of today in any industry or organizations are facing enormous challenges. To be a success in todays world it becomes mandatory for an organization to be competitive in every aspect of business. This can be achieved through excellence in design, manufacturing, marketing and after sales service. The keys to this excellence for any organization are its people and their productivity. The ever-changing business environment and its stringent requirements as regards quality, cost and delivery are putting undue pressure on the organizations to perform par excellence. This competition induced stress has to be borne by the people of the organization, who as depicted as the most vital resource in this philosophy, most abundant yet scarce. Managers in order to excel, managers enhance their effectiveness and usefulness to the organization. They are in constant search of solutions, which can help them in the continuous quest for excellence of theirs and their team members.

4. RESEARCH METHODOLOGY
The project being undertaken is exploratory research. Where in all these approaches of exploratory research like:

4.1 DATA COLLECTION APPROACH

The base on which a study rests is the information that is embedded in it. The data for this study will be obtained as a blend of both Secondary and Primary sources.

4.1.1 Secondary Data

Already published data will form the starting point for the study. This includes: Official Reports on related matters. Literature of quality management available at Nestor pharmaceuticals Limited. Books and Journals on quality process of Pharmaceutical Companies. Books on Quality, and Operation Management

4.1.2 Primary Data

Data will be collected specifically for the research needs at hand. The sources include: Interviews of 4 Managers at Nestor Pharmaceutical ltd. Questionnaires: A structured, non-disguised questionnaire is prepared. This is then presented to concerned people at Nestor Pharmaceutical Ltd. 10 employees from middle and Senior Management are contacted for the purpose of getting the required information.

5. FINDINGS AND ANALYSIS 5.1.THE QUALITY MANAGEMENT SYSTEM OF THE FIRM RESPONSIBLE FOR MANUFACTURE.
On receipt of any raw materials or packaging material etc., outer covering like jute bag or any particle shedding outer covering is removed. The consignment is checked for any damage to the supplies during transit. The Q.C. wing is intimated of the receipt of the goods. Authorized person from Q.C.D. comes to the store & verifies the information given on the container with regard to Product Name, Batch No., Mfg., Exp., Mfd. By, No. of containers & tallies it with the concerning documents. Leakage or damage (if any) is ruled out. Any gross deviation is brought to the notice of the Q.C. Manager, if deemed fit sampling from the various containers is done by Q. C. Person by the standard procedure sample from each

container& the testing is commenced as per the specified pharmacopoeia or in house specification. Yellow slips are pasted on the consignment ,when found O.K. green slips signed & dated by Q.C. in charged are pasted on the containers & if not so red slips. Rejected slips are pasted on the containers. They segregated to rejected material store & returned to the supplier at the earliest. Q.C. department personnel are authorized to draw samples from various stages of manufacture & ascertain whether the specified methods have been followed in full.

Sample of finished goods is drawn from various stages of production & the goods analyzed as per specified procedures & specifications. Intimation of its results is sent in writing & any material in doubt is withheld till confirmation of its result & release by Q.C.D. Any tests for which facilities do not exist are carried out by the approved testing laboratories & the coordination is done by the Q.C. Dept. The Q.C. Dept. is also responsible for process validation, preparation of various documents related to manufacture & calibration of various equipment. Release of finally tested product takes place in the following way: 1 - As soon as the product is finally tested, analyst prepares the analytical report as per Quality Control Monograph. 2 -Product which is passing in all respects is approved. 3 -Analyst signs the report with date

4 -Quality Assurance Manager signs the report or authorizes an approved analyst to sign on his behalf. 5 -Analyst releases the Release Order & Stamps each corr. box `QUALITY APPROVED and Packaging stickers are fixed on the individual containers indicating Name of the Product, Batch No., Mfg. Date, Exp. Date, Qty. 6- Attach copy of the analytical report together with in-process controls to the Batch Manufacturing Record. 7 -Analyst signs the Batch Manufacturing Record with the date of completion of analysis. Quality Assurance Manager finally signs the Batch Manufacturing Record and keeps it in safe custody. 8- Prior to packaging of the product, production supervisor requests for the Master Batch record along with Packaging portion of the Master Batch Record. 9 -In case, the product is not passing as per Quality Control Specifications, the production is rejected and the matter is investigated along with Production Manager. Results of investigation are intimated to Director Production for further action. Much emphasis is given to training which covers operational training & exposure to GMP & GLP. The S.O.P. is available for different operations. Products are manufactured as per procedures given in Master Formulation Record. The assessment of effectiveness of Quality Management System is done by periodic Self inspection.

TRAINING REPORT
INTERNEE: Preeti Enrolment no.-2012/542/025

R.

AREA

OBSERVATIONS

O. 1 STORE

I R.M.STORE

Separate Receiving bay is for the receiving of the RM. Material documents are firstly verified at security gate, and then proceed for store for complete verification. Register for received material in Nestor internal software.

Industrial vacuum cleaner is there for the de dusting with the ID no allotted Separate area for the Approved RM & Under Test with the Green & Yellow Band Indication Gowning procedure for the receiving of the RM from the Receiving Bay. The checklist is followed at the time of receiving of the RM. There is separate area for the cold storage RM.

SAMPLING

There is Separate Sampling area for the API & Excepeint. Sampling has been performed under LAF and surrounding area is Class D The gowning is followed for the Sampling.

 II P.M.STORE

The RLAF is on before-30min for the sampling. WFI and storage the same with proper status label The Verification of the weighing balance are done on the daily basis.

DISPENSING

The Dispensing is done in the separate Area for the API , Excepient. Dispensing has been performed under LAF and surrounding area is Class D Separate washing area to clean the dispensing equipments with WFI The RLAF is on before-30min for the Dispensing. The cleaned Dispensing Accessories are used for the dispensing. Pressured Differential and the Temp & RH for the Area is recorded.

The RM to be dispensed is pass through a separate static pass box. The Verification of the weighing balance are done on the daily basis.

The PM store has separate area for the Approved and under test PM. The sampling for the PM is done as per the AQL and the Sampling Procedure (n+1). The PM is issued as per the Code mentioned in the work Order. There is separate dispensing as well sampling room for PM in packing Material store. The Pre printed material is stored in the Lock & Key. The Labels are counted before issuing to the Production. The PM issued in the Cage System. The Code is matched with the Work order of the BPR. If the Excess material is required the EMRN is given to the Store. The MRN is done after the batch completion and the same is counter checked by the QA

Handling of Printed Packing Materials

The Pre-printed Packing material is stored in the Separate lock and Key in the separate area. The Dispensed PM is cross verified by the QA Person

NAME OF UNIT: Nestor pharmaceuticals ltd.(Faridabad) DATE OF VISIT : 15.05.2013

5.2 THE OUTLINE OF ARRANGEMENT FOR IN SERVICE TRAINING AND HOW RECORDS ARE MAINTAINED. TRAINING PROGRAMME: Outline of arrangements for basic and in service training
and how records are maintained. The Organization has fixed a programme for training for the staff as follows: Induction Training 1 At the time of joining once / each level Periodic 2 Technical Supervisors Quarterly 3 Maintenance Supervisors Monthly 4 Cleaning Personnel Monthly 5 Workers Quarterly _ They are briefed about GMP practices during training. _ Newcomers are also getting training regarding their duties as well as GMP Practices _ Staff / Supervisors ability is also assessed during self inspection (Audit). _ Supervisors are getting training for concepts for quality assurance, quality of the drugs and its understanding and implementation. _ Company Policy is not to allow newcomers / visitors normally to the production area. In case newcomers / visitors are allowed to enter they are escorted by the senior personnel.

5.2.1 HEALTH REQUIREMENT FOR THE PERSONNEL ENGAGED IN PRODUCTION:

All personnels engaged in production are examined regarding their health and physical fitness by the authorized Doctor at the time of joining and at intervals of one year. Personnel engaged in visual inspection work are examined periodically for eyes by Ophthalmologist. Personnels are trained for personal hygiene like hair cutting, nail cutting, moustaches/beard cutting, bindies, bangles, nail polish etc. Personnel should not be suffering from any chronic / infectious diseases.

5.2.2 PERSONNEL HYGEINE REQUIREMENTS, INCLUDING CLOTHING:

The Company is providing to the Staff / Workers Change Room, Toilet, Wash-Basin for hand wash (separately for Ladies & Gents). The Company has also provided pigeon cabinets for individuals with locking facility. To avoid direct contact with drug the personnel are provided uniforms such as hand Gloves, Caps, Coats & Foot wears, Masks etc. The Company also provides soap, hand drier for drying hands.

BETA BLOCK
STERILE AREA DIMENSION (in meter)

Washing and sterilization area Manufacturing room area

5.827 X 7.079) (1.840 X 2.837)

TABLET

Granulation area

6.971 X 5.737

Compression area

3.041 X 2.709 X 2.00

Coating area

7.581 X 2.709

Quality Control Lab

25.031 X 5.878

5.3 AVAILABILITY OF WRITTEN SPECIFICATIONS & PROCEDURES FOR CLEANING OF MANUFACTURING AREA & EQUIPMENT Standard operating procedures are available for daily, weekly & monthly cleaning/maintenance of manufacturing areas & equipment. Near each major equipment the washing procedures are displayed in local language (Hindi) understandable by the operators. One set of such instructions in a file are available in addition with production head & quality control head. The operators are instructed to de-dust the working area & equipment in the beginning & at the end of the shift. Instructions are there to wipe / clean all surfaces once or more often daily as required. Floors are cleaned first with dry mop & then with wet cloth dipped in water containing deodorants like phenyl or detergents. Likewise the additional instructions are available for cleaning walls, electrical appliances, window panes etc.

5.4 THE PLANNED PREVENTIVE MAINTENANCE PROGRAMME FOR EQUIPMENT AND RECORDING SYSTEM DAILY:
1. Every machine is cleaned after every operation/change over through dry/ moist means. 2. Every machine is greased and oiled every day. 3. Change parts, is cleaned adequately with materials like Liquid soap / detergent & raw water.

4. Finally mopped with cotton cloth and then dry the part.

QUARTERLY: (Perform the activity if in approach or get serviced from suitable agency)
5. Dismantled the change parts or outer devices attached and cleaned with kerosene oil, petrol or other suitable cleaning agent. Then greased or oiled. If required, change the part which is likely to go out of order in near future.

ANNUAL: (Perform the activity if in approach or get serviced from suitable agency)

5.5 PURPOSE FOR SANITATION 5.5.1 AVAILABILITY OF WRITTEN SPECIFICATION AND PROCEDURES FOR CLEANING OF MANUFACTURING AREAS AND EQUIPMENTS.
Purpose of equipment cleaning is removal of product residues of previous product /batch and to clean & sanitize the equipment for the next batch. Detachable parts of large equipment & small equipment are taken out to cleaning area assigned for the purpose and washed properly with suitable detergents and plenty of water. Written cleaning procedure / SOP are provided for all equipment, manufacturing area & laboratory. Whenever, there is a product change final rinse water should be tested for presence of traces of active ingredient/s of the last batch processed. Equipment should be tagged with words like To be Cleaned or Ready for Use. Purpose of cleaning the area is to remove dust particles, powder or particles of drug/s of previous batch. Phenyl, Savlon, Dettol etc. is used for final mopping of the area after removal of dust particles from floor, doors, and windows of the premises. Written cleaning procedures for different areas are provided.

5.6 THE ARRANGEMENTS FOR THE PREPERATION, REVISION AND DISTRIBUTION OF NECESSARY DOCUMENTS FOR MANUFACTURE.
Preparation of documents, its revision & distribution as required is co-ordinated by the head of Quality Control Department. With the help of information & data obtained from the production wing. The Quality Control Department has the responsibility to ensure that all information required as per provisions of Schedule U of Drug and Cosmetics Rules 1945 is available on concerned documents & the procedures are as per requirement of Good Manufacturing Practices. While preparing process sheet, in-process sheet etc. It should be ensured that following information is available. 1. Name & Address of the firm 2. S. No. 3. Master Formula Ref. No. 4. Product Name generic & patent (if any) 5. Batch No., Mfg. & Exp. 6. Date of Commencement 7. Date of Completion 8. Name Quantity Required Overages, Qty. used of all ingredients. 9. Sign of person doing the operation. 10. Name of persons performing various vital operations for that batch. 11. Date, time & equipment used for various operations. 12. Weigh / Volume at different stages. 13. Recording of in-process controls carried out, its time & conducted by. Likewise QC has to prepare & approve all stationery used like under test, rejected, approved quarantine, clean, to be cleaned. 14. Requisition slip for raw & packing materials, identity slips etc 15. Calculations for the required batch size as per master formula has to be confirmed by Q.C.D. & necessary process sheets with assigned batch Nos issued to production wing. 16. Q.C. has to validate various parameters during production & in order to change any previous specifications, it has to cross check & authenticate new parameters & assure its workability.

After manufacturing operations, Q.C. has to verify the production records & sign them to certify that the batch in question is of standard quality & proper precautions & in-process controls have been carried out. 17. Q.C. has to maintain these records & the control samples for the specified period + extra period say 3 months after the expiry date. Q.C. has to periodically examine these samples & carry out stability studies (shelf life) of selected batches of each product & modify its shelf life /overages to be used based on the information obtained from these tests.

STUDY OF PRODUCTION OPERATIONS

R M RECEIPT ANALYSIS AND APPROVAL BY Q.C. WEIGHING FOR REEQUIRED BATCH

R.M.RECEIP

ANALYSIS OF MIXED MATERIAL

MIXING

SCREENING

INSPECTION

POLISHING

STRIP BLISTER PACKING

DESPATCH TO STORES

FINAL TESTING FROM Q.C.

CARTON

5.7 RAW MATERIALS HANDLING PROCEDURE

1. On receipt of any raw materials a) Check the following on the containers & compare with the concerned documents. 1. Name of the material. 2. Batch no., Mfg. Exp. Dates 3. Manufacturers name. 4. Supplier name (if any) 5. Quantity Gross weight, Nett Weight, total quantity received any discrepancy should be brought to the notice of the Q.C. Manager & the concerned supplier. b) Check the condition of the consignment e.g. labels, damage to the containers, spillage, leakage deterioration etc. On receipt, if found satisfactory, the Q.C. department may be intimated to check & take samples for analysis & if found not satisfactory it may be returned to supplier forth with or segregated, to be returned at the earliest. Ensure availability of proper clean, dry scoops, sampling rods or pipes preferably of stainless steel. Prevent cross contamination. c) Before keeping the consignment in quarantine (under test area) & before sampling, the outer jute covering (if any) or any other packing which might cause contamination should be removed. De-dust the containers & keep them in UNDER TEST area with relevant information marked on red slips & pasted near the original label. After sampling using standard procedure by Q.C., properly place caps/lids etc & store till release. d) On receipt of written release order or test report, goods should be removed to approved (O.K.) area after removing under test slip at the earliest & affixing tested or quality approved green slips. e) Thermo labile & sensitive materials should be stored in air conditioned areas or dehumidified areas as required. f) Immediately after receipt all incoming materials should be entered with all details in-Incoming register and in official register. .g) A goods receipt note in Duplicate should be made:- First to A/c Department. - Second copy retained with stores in-charge.

h) First in First out (FIFO) principle should be observed for all materials (except in special cases where material of some specific grade or quality is to be issued). Storage should be such as will, facilitate observation of this principle. i) Similar procedure should be adopted for the packing materials etc. j) Raw materials should not be placed direct on the floor. They should be stored on raised platforms or almirah, racks etc. k) During sampling, storage, dispensing, effort should be made to prevent contamination of one ingredient with another. l) Raw Materials with 3 years or lesser life should be retested every six months after receipt if it remains unconsumed or one year for materials having life more than 3 years. m) Inspect the materials in store, at regular intervals say every month or so, to ensure proper maintenance of containers. n) Issue of raw materials should be against written requisition only & proper records maintained in this regard. The weighing & measuring equipment should be of appropriate capacity e.g. too small a quantity should not be weighed on huge balance & vice-versa. o) All materials should be placed at the proper place after use. Materials should be so placed in systematic manner that locating any material is easy. Goods in jute bags etc. should preferably be stored separately. p) Records on suppliers performance should be maintained & vendor rating should be done so as to procure material from the ideal source every time.

5.8 THE QUALITY CONTROL SYSTEM AND ACTIVITIES OF THE Q.C.DEPARTMENT PROCEDURE FOR THE RELEASE OF FINSHED PRODUCT
For Quality Management, the firm has a quality control unit which has the responsibility & authority to approve or reject all the components, drug product containers closures, in process materials, packing materials, labeling & drug product & the authority to review production records to assure that no errors have occurred and that they have been fully investigated. The quality control unit is responsible for approving or rejecting drug products manufactured, processed, packed or held under contract by another company.

Adequate laboratory facilities for testing & approval or rejection of the components, drug product containers, closures, packing materials, in-process materials & drug products are available with the quality control unit. Most of the operations carried out in production & quality control wing are as per the specified written procedures. The head of quality control wing is independent of the head of production wing.

On receipt of any raw materials or packaging material etc., outer covering like jute bag or any particle shedding outer covering is removed. The consignment is checked for any damage to the supplies during transit.

The Q.C. Wing is intimated of the receipt of the goods. Authorized person from Q.C.D. comes to the store & verifies the information given on the container with regard to product name, batch no., mfg., exp., and mfd. By, no. of containers & tallies it with the concerning documents. Leakage or damage (if any) is ruled out. Any gross deviation is brought to the notice of the Q.C. Manager & if deemed fit the consignment is rejected & returned forth with.

If found O.K. sampling from various containers is done by the Q.C. person by the standard procedure as per route N+1 formula & the testing is commenced as per the specified pharmacopoeia or in house specification.

Red coloured under test slips are pasted on the consignment and when found O.K. Green, approved slips signed and dated by Q.C. In-charge are pasted on the containers and if not complies to specification, Yellow rejected slips are pasted on the containers. They are segregated to rejected material store & returned to the supplier at the earliest. Q.C. Department. Personnel are authorized to draw samples from various stages of manufacture & ascertain whether the specified methods have been followed in full.

Sample of finished goods is drawn from various stages of production & the goods analyzed as per specified procedures and specifications. Intimation of its results is sent in writing and any material in doubt is withheld till confirmation of its result.

5.9 RELEASE
Release of finally tested product takes place in the following way: 1. As soon as the product is finally tested, analyst prepares the analytical report as per Quality Control Monograph. 2. Product which is passing in all respects is approved. 3. Analyst signs the report with date. 4. Quality Assurance Manager signs the report or authorizes an approved analyst to sign on his behalf. 5. Analyst affix Quality Approved Stamp assures that these are fixed on the individual container. 6. Attach copy of the analytical report together with in-process controls to the Master Batch Record. 7. Analyst signs the Master Batch Record with the date of completion of analysis. Quality Assurance Manager finally signs the Master Batch Record and keeps it in safe custody. 8. Prior to packaging of the product, production supervisor requests for the Master Batch record along with Packaging portion of the Master Batch Record. 9. In case, the product is not passing as per Quality Control Monograph, the production is rejected and the matter is investigated along with Production Manager. Results of investigation are intimated to Production Director for further action.

5.10 TO STUDY OF THE WAY IN WHICH THE GMP COMPLIANCE OF THE CONTRACT ACCEPTER IS ASSESSED:
The organization has no such type of contract activity so far in manufacturing currently for analysis, Samples of products / materials sent to approved testing laboratories by Q.C. Deptt., for which the facilities are not available and such contract analysis is co-ordinated by the Q.C. Deptt. Only. The facilities, equipments, protocols etc. required for such tests are first inspected, checked by Q.C. head to satisfy himself and then only the samples for such tests provided. In this case the product/material is released only after receiving the part analysis report also from approved testing labs and the reference of such test, report no. etc. is provided in the final test report of the material/products.

5.12 TO STUDY THE DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL 5.12.1 ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION.
The organization has 50 distributors; they send their orders to head office. This in turn sends it to the Factory. Store person feed the orders in computer so that they get an invoice with batch no. etc. It works on FIFO (first in first out basis) for product as well as orders. Invoice is checked by store in-charge for goods stock position (if required to make cartons & strap them etc.) then send to the dispatch Dept. Copy of invoice is sent to the head office for further action. A record of distribution of final product of particular batch is maintained in kept in the B.P.R.

5.12.2 ARRANGEMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALLS.

1. Stock of product which may be returned to stores for any reason should be accounted for and dealt in consultation with Q.C. Manager. 2. Returned goods must be isolated on receipt, clearly identified and recorded indicating the details of the consignment and the reasons for return. 3. The Q.C. Manager should promptly examine the returned goods to determine whether such goods should be reprocessed or destroyed or even released for distribution. 4. Further disposal of examined goods should be authorized by the Quality Control Manager. If destruction of the goods has been recommended, this should be done under supervision, of Q.C. Manager and details of such destruction must be recorded. 5. Reprocessing of returned goods should be done in accordance with the instructions given by the Q.C. Manager. 6. In case of reprocessing, re-distribution of returned materials, information for such returned should be sent to Central Excise Deptt also.

5.12.5 PRODUCT RECALL

1. All the product complaints are to be dealt according to SOP. 2. If the action requires a product withdrawal completely or partially the Q.A. Manager should inform the General Manager / Director regarding the results of the investigation and advice to recall the product or a particular batch completely or partially with the approval of the above. 3. Q.A. Manager should withdraw the Bin card of those particular batch/es of the product from F.G. store and issue necessary instruction to sales distribution to recall the above batch/es of the product from the market. 4. On recalling Q.A. Manager should ensure that all the materials that are recalled are accounted for. 5. As soon as the complete stock is reconciled, the Q.A. Manager should initiate necessary action to rework or destroy the stocks in consultation with the General Manager / Director. 6. The destruction of the recalled batch/es should be carried out in the presence of Q.A. Manager and the Production Manager.

5.13 TO STUDY OF THE SELF-INSPECTION SYSTEM:

Self inspection is an independent review and evaluation of entire manufacturing operations which cover Current Good Manufacturing Practices (CGMPs) adopted during manufacturing, testing and packing operations of the plant. It also verifies the effectiveness of Quality Assurance Programme and its compliance with the regulatory affairs. This programme will provide: a) Overall view of the operational strengths and weaknesses. b) Opportunity to correct the defects in the system. c) Assure product Quality.

5.13.1 FREQUENCY OF SELF INSPECTION:

a) Self inspection is conducted once in an year by plant personnel from Production, Quality Control and Management.

5.13.2 INSPECTION TEAM:

a) Self Inspection:

Self Inspection is conducted by two or more experts from plant consisting of manufacturing experts and Q.A. experts.

5.13.2 INSPECTION PROGRAMME:

1. The inspection is to be carried out as per a definite programme and schedule. 2. Identify areas and systems to be inspected and should be completed as per the schedule. time bound

5.13.3 TECHNIQUES OF SELF INSPECTION:

In self inspection one is critically examining the activities of a department by interviewing and try to gather as much information as possible through their co-operation. Compare the master batch record with the original product file. Examine the records, documents, procedures etc. Check them for the adherence to SOPs. All critical and major defects should be immediately investigated and action plan with time bound schedule is to be finalized. Compliment any good points observed. Discuss the points observed in the section and come to an agreed action plan with time bound for any critical, major or minor points observed during inspection.

5.13.4 WHAT TO BE SELF INSPECTED:

Self Inspection will cover all line and support observations and departments that directly or indirectly affect the quality of the product. 1. Line operations: Ware housing, dispensing, manufacturing, packaging and distribution. 2. Support functions: Quality control and assurance, vendor development, engineering. 3. Vendors, contract manufacturing. 4. Key systems in all departments. The above points are elaborated as follows: a) Spend 30% of the total inspection time physically inspecting the facilities, manufacturing operations, support systems etc. b) Balance 70% of the time should be spent to check the adequacy of cleaning, calibrating and conditions of the equipments used for manufacturing.

c) Choose a process or procedure of manufacturing, challenge its completeness, verify the entire process and check the degree of adherence. d) Pick up any product and check the entire system i.e. from raw material receipt, test reports, manufacturing procedure, SOPs, packaging, distribution, etc. Critically examine all the records, log books, test reports, raw data to trace a product from raw material to distribution stage. e) Check the output of process for average yield. f) Check the physical appearance of the products from the finished packs.

5.13.5 SELF INSPECTION REPORT:

At the conclusion of the self inspection a comprehensive report should be prepared within 10 days giving the self inspection finding and corrective actions required and should be submitted to the management. Any defect observed should be classified as critical, major, and minor and also record if possible the root cause. Agreed action plan with time bound schedule should also be included in the report.

5.14 SELF INSPECTION COMPLIANCE AND FOLLOW UP:

The defects or deficiencies should be reviewed as per the action plan and compliance report is submitted to the management. This report should form the basis of the next inspection. Examples of critical, major and minor deficiencies: Critical, defects: a. Cross contamination of raw materials during storage. b. Product manufactured without batch record or in-process data or unauthorized changes. c. Product mix-ups. d. Incorrect labels. e. Results out of specifications, but still released. f. Product released without Q.C. approval. Major defects: a. Rejected materials not segregated. b. Balances not calibrated. c. No SOP for equipment, operation cleaning etc. not recorded. d. Batch processes not documented as per shape.

e. Analytical data or raw data not available. f. Reference Standards, normalitys not available from raw data. g. Process: Weight variation usually going out of specification but still manufacturing is going on. Minor defects: a. Areas not cleaned regularly. b. Approved/released stickers missing in containers. c. Cleaning SOP not signed. d. Temperature not recorded in products.

1. Has Nestor Pharmaceutical Limited implemented a Pharmaceutical Production approved Quality Program?

Interpretation: As per the survey, 88% of the respondents said that Nestor Pharmaceutical Limited has implemented Pharmaceutical Production approved quality programs and according to 12% of them the firm has partially implemented Pharmaceutical Production approved quality programs.

2. At which level do the Quality activities take place in the company?

Interpretation: The results show that 83% of respondents are performing the quality activities at all levels. Only a small percentage of companies perform the activities at management or, operational or, quality department or shop floor levels. This proves that quality implementation should involve the whole company and all employees. 3. Which Quality Tools or Techniques are being used at Management Level?

Interpretation: As per the graph that 40% of responses reveals that they use Benchmarking, 31% of them using Affinity diagram and 2% of them Quality Function Deployment as the quality tools at the management level. There are 10% of respondents who selected the answer Other. These companies are using either in house system or other tools and such as tools and techniques, Brainstorming, Constant Monitoring SPC, even they dont use any tools and techniques at the management level.

4. Which Quality Tools or Techniques does your company use for Problem Solving?

Interpretation: From the data, it was found that 55% of responses cause and effect and fault tree analysis as the most useful tool and technique for problem solving. The answer to this question is the same as the answer that was expected. This is because CE helps user to discover the possible root cause of defects and then helps user understand the failure mechanisms involved. Fault tree analysis is another tool that can help users detects the failure modes. There are 4% that responded that dont use quality tools and techniques for problem solving.

5. Which Quality Tools or Techniques, Philosophy does your company use for Process Improvement?

Interpretation: There are 65% and 9% of respondents that concentrate on using two quality techniques, SPC and Cause & Effect respectively for Process Improvement. This is because SPC and Cause & Effect can find a different phase to the process and prevent the problems which occur during the process. In the results, there are 2% of them said that they dont implement any tools or techniques for process improvement. 6. Which Quality Tools or Techniques does your company use for Data Collection analysis and display?

Interpretation: Figure that 90% of the responses use three quality tools and technique for data collection. There is high usage of sampling because it is a tool for collecting data that is cheaper than other tools or techniques and saves time. Process sampling is a part of SPC, thats why the percentage of respondents that use SPC is high for data collection. There are 4% of respondents that use other tools and techniques, such as customer correct action analysis.

7. Which Quality Tools or Techniques does your company use to monitor quality in different processes and company used to minimize the defects?

Interpretation: Figure shows the percentage of SPC that has been used to monitor quality in different processes. It was found the SPC is mostly used in the Manufacturing Process and Measurements sector, whereas it has not applied very much in the Material Selection and process selection.

Most of the responses recommended DOE to be used in the Material Selection and Manufacturing Process.

The use of DOE to monitor quality in different process

25% 15%
25%

35%

Material Selection Mould Design

Product Design Manufacturing Process

FMEA is used for Product Design, Manufacturing Process and Mould Design, but it is seldom used for Machine Maintenance. This is because FMEA is a powerful aid to undertaking

The use of FMEA to monitor quality in different processes

12%
35% 8%

28%

17%

Material Selection Mould Design Assembly

Product Design Manufacturing Process

advanced quality planning of new products and services, since it assists in the development of

robust and reliable production and delivery methods. The percentage of FMEA that has been used to monitor quality in different processes in shown in Figure. The graph shows very clear which Quality Tools or Techniques are recommended to use to minimize those different defects. The results show that SPC is usually used to minimize the Bowing defects. DOE is mostly used to reduce defects of Warpage, Non-fill and Sink Marks. There is high percentage shows that Poka-Yoke is mostly used to minimize the Bowing defect.

8. Has the company benefited from the application of Quality Tools and Techniques?

Interpretations: Nestor Pharmaceutical Limited that have benefited, 93% of the responses benefited by tangible results, such as productivity, money and 5% of them said they are getting benefits partially such as reputation of the company, increasing of market share, etc

6. SUMMARY AND CONCLUSION

Quality of management remains a key factor for all credit ratings. Lack of a seasoned management team in areas like R&D, regulatory affairs, business development, and manufacturing can significantly increase the business risks of a pharmaceutical company. The industry is also seeing several acquisitions, driven by the need for inorganic growth. Besides a strong balance sheet, depth in management is a prerequisite for the successful handling of integration related issues that acquisitions throw up almost invariably. Going forward, there would be increasing competition for the trained-manpower available, especially in critical areas like R&D and business development. Therefore, professional management structure and focus on human resources would be of crucial importance for the industry. Due to increasing competitive market pressures, more and more pharmaceutical companies are adopting process improvement strategies that are established in other industries such as Six Sigma, lean manufacturing. Issues driving these needs include the necessity to improve cycle time, marketing and packaging efficiencies to monitor supply chain and streamline manufacturing processes to maintain profitability and remain competitive in todays global market. In the past few years, a few pharmaceutical companies started adopting Six Sigma mainly to reduce cycle time and cost. New products drive revenue growth In general, revenue growth of a pharmaceutical producer depends on new product introductions, which fulfill unmet therapeutic needs. Hence, a producer's ability to innovate and develop new products is critical to its success.

7. SUGGESTIONS
1. Starting materials purported to be used as a pharmaceutical starting material must meet all of the quality criteria suitable for the intended pharmaceutical use. 2. Starting materials designated to be of pharmacopoeial quality should meet the respective requirements before the material can be labeled and accepted for the intended pharmaceutical use. 3. Starting materials should be manufactured, handled and distributed according to GMP from the moment they are designated for pharmaceutical purposes. 4. National and regional legislation on medicinal products should be extended to cover starting materials. 5. National and regional legislation on medicinal products, including starting materials, should be extended to free ports. 6. Key parties in the chain producers, traders, forwarders, tenderers, brokers must be authorized for their activities by the competent health authority of the country in which each activity occurs. Authorization should be appropriate for each key activity in the chain, in accordance with the risk assessment of the activities. Such authorization requires adequate inspection. Failure to follow the requirements of the authorization must have appropriate legal consequences. There should be free and open exchange of information on such cases between governments. 7. GMP/GDP observance should be monitored by GMP/GDP inspection. 8. All pharmaceutical manufacturers must have access to suitably equipped analytical testing laboratories in order to control incoming materials and final products. 9. While low-cost manufacturing capability is a key strength for Indian pharmaceutical

companies, it is also critical for those targeting exports to regulated markets to maintain systems and processes that ensure product quality. ICRA, therefore, assesses the systems followed by the company during manufacturing, its testing facilities, the quality of its trained manpower, and the quality of its documentation during manufacturing. Backward integration may be crucial in sustaining cost advantages in exports, as that usually provides for greater value addition. For instance, some Indian manufacturers have been able to sustain profitability even after over 90% price erosion on generics, through effective cost control.

10. Upgrading and maintaining a manufacturing facility that meets the standards of the regulated markets call for significant financial commitments. Also, inspection and approvals being a timeconsuming process, companies with existing facility approvals from agencies like US FDA4, UK MHRA5, and ANVISA6 can have a crucial time advantage over others. Besides, companies with quality manufacturing facilities can also cash in on potential opportunities in the field of contract manufacturing and custom synthesis.

8. LIMITATIONS
It is a conclusive research & in order to find the exact reasons for the responses received there is a need to conduct in depth analysis and interpretation. Subjectivity is the main limitation of the study. It is very difficult to verify the research results. Some of the areas were disinterested in giving the responses and some were unable to come out with appropriate responses. Visiting various places for the study consumed lot of time. Some important aspect like master formula record, batch production is extremely sensitive which a production unit does not share with management trainees. Confidentiality is maintained.

9. REFERENCES
Bhaskar Mazumder, Sanjib Bhattacharyaand & Abhishek Yadav, Total Quality Management in Pharmaceuticals: A Review, International Journal of PharmTech Research. Page: 367 Yong,J,Wilkinson,A(1999),The state of total quality management: a review, The International Journal of Human Resource Management 10(1), 137-161. S.poongothai,R.Havarasan,L. Karthikeyan, S.Arul,Total Quality Management:The path for continuous Quality enhancement in pharmaceutical sector,Asian Journal of Biochemical and Pharmaceutical Researchissue 2(vol.1)2011. Total quality management: a continuous improvement process. PHCC education foundation.1996 Goetsch,L.David Jersey,1995 Juran, J.M.1951, Quality control Handbook, New York: McGraw-Hill. McAdam,Rodney and Barron, Nigel, 2002. The Role Quality Management in Pharmaceutical Development: Clinical Trails Analysis. International Journal of Health Care Quality Assurance, 15(3): 106-123 Enders JE. Quality assurance and control. In: Gennaro AR. (Ed.). Remington: The Scirnce and Practice of Pharmacy, 20th Ed., Vol.1. Lippincott Williams & Wilkins, New York. Bank J.Total Quality Management. 6th Ed..,Prentice Hall Private Limited,New Delhi. Choda SR. ISO:9000 Quality management system in pharmaceutical sector. Pharma Times 2003;35 (1):7-11. and S. David.,Implmenting Total Quality/Prentice-Hall, New

ANNEXURE 1Nestor Product A. 1. 2. B. 1. 2. Cardiac Glycosides Injection Digoxin Injection BP 0.25mg Digoxin Injection USP 0.25mg Beta Blockers Tablets Propranolol Tablets BP 10mg/40mg/80mg/160mg Propranolol Hydrochloride Tablets USP 10mg/40mg/80mg/160mg

Injection 1. 2. C. 1. 2. 3. 4. 5. D. 1. 2. 3. 4. E. 1. Propranolol Injection BP 1mg Propranolol Hydrochloride USP 1mg Antiarrhythmic drugs Injection Lignocaine Injection BP 0.5% w/v/1% w/v/2% w/v Lidocaine Hydrochloride Injection USP 0.5% w/v/1% w/v/2% w/v Lignocaine and Adrenaline Injection BP 20mg LIGNORIN (Lignocaine and Adrenaline Injection BP) 20mg + 0.01mg Procainamide Injection BP 100mg Anti-Hypertensives Methyldopa Tablets BP 125mg/ 250mg/ 500mg Methyldopa Tablets USP 125mg/ 250mg/ 500mg Reserpine Tablets BP (80) 0.1mg/ 0.25mg/ 0.5mg/ 1mg Reserpine Tablets USP 0.1mg/ 0.25mg/ 0.5mg/ 1mg Diuretics Acetazolamide Tablets BP 250mg

2. 3. 4. 5. 6. 7. 8. F. 1. 2. 3. 4. G. 1. 2. 3.

Chlorthalidone Tablets BP 50mg/100mg Chlorthalidone Tablets USP 50mg/ 100mg Frusemide Tablets BP 20mg/ 40mg Furosemide Tablets USP 20mg/ 40mg NESIX Tablets (Furosemide Tablets BP) 10mg Hydrochlorothiazide Tablets BP 25mg/ 50mg Hydrochlorothiazide Tablets USP 25mg/5 0mg Antiplatelet drugs Aspirin Tablets BP /USP 75mg/ 450mg/ 150mg/ 500mg/ 300mg/ 600mg Soluble Aspirin Tablets BP 75mg/ 300mg/ 500mg Dispersible Aspirin Tablets BP 75mg/ 300mg/ 500mg PANSPRIN Tablets (Aspirin Tablets BP) 300mg Vasopressors Injection Dopamine Hydrochloride Injection USP 40mg Phenylephrine Injection BP 10mg Phenylephrine Hydrochloride Injection USP 10mg

ANNEXURE-2
QUESTIONNAIRE Q1. Has Nestor Pharmaceutical Limited implemented a Pharmaceutical Production approved Quality Program? Q2. At which level do the Quality activities take place in the company? Q3. Which Quality Tools or Techniques are being used at Management Level? Q4. Which Quality Tools or Techniques does your company use for Problem Solving? Q5. Which Quality Tools or Techniques, Philosophy does your company use for Process Improvement? Q6. Which Quality Tools or Techniques does your company use for Data Collection analysis and display? Q7. Which Quality Tools or Techniques does your company use to monitor quality in different processes? Which Quality Tools or Techniques does your company used to minimize the defects? Q8. Has the company benefited from the application of Quality Tools and Techniques?