Life science companies experience

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CHAPTER 1

INTRODUCTION

Life science companies experience no lack of quality system ideas, quality system conversation, quality system arguments, quality system implementation methods, etc

After all, even the required systems of quality management such as the FDA's GMP, GCP and GLP regulations and guidelines are specified to a certain extent but still don't determine all of the whens, hows, whys and whats of in-house quality system management. As a result, life science companies are left with a few decisions to make:

  • On what system(s) should a quality system be based?
  • How will the quality system's data be managed?
  • How will the quality system's documentation be managed?
  • What will be the KPIs (key performance indicators) of the quality system?
  • How will a need for improvement be justified?

A truth is that big pharmaceutical companies never worried about cutting costs and improving efficiencies because the industry didn't have to. The cost-containment and process-improvement obsession of the rest of the manufacturing world was never a worry for the pharmaceutical industry, simply because it was too wealthy to worry about it

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Instead of cost restraints and improved efficiencies, the focus of pharma companies has always been on The Next Big Thing. It was only five years ago that pharma companies even started to become interested in managing front-end costs through methodologies like lean and Six Sigma.

The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality" is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents' performances.

ISO 9000 is a generic name given to a family of standards developed to provide framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.

Aim & Objectives

The overall aim of this project is to check the QUALITY MANAGMENT SYSTEMS (QMS). Does a QMS improve the quality of the systems, Do formal certifications like ISO 9001 and DEMING ,BALRIDGE ,EFQM support and encourage developers to use the QMS and by this increase the quality of their work? And also check QMS in Pharmaceutical industry and is it benefit form these QMS.

In order to meet the aim following objectives have been defined:

  1. What is QMS
  2. To define QMS and types of QMS, like ISO 9001 and DEMING ,BALRIDGE ,GMP
  3. Defining the clauses of ISO series
  4. To identify Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7
  5. To identify how Pharmaceutical get benefit from QMS
  6. To identify how pharmaceutical can be improved by QMS
  7. 1.1Project context

    This project represents some important theory on this subject. The basic concept behind this project is to check which Quality Management System is adopted in different pharmaceutical companies.

    1.2 Structure of this report

    Chapter 1 of this report emphasises the importance of the study in the current climate and objectives as well.

    Chapter 2 explains the methodology adopted and how this methodology helped to achieve aims and objectives.

    Chapter 3 reviews literature relating to Quality Management Systems in the pharmaceutical. Internet, library or e-journals were used as source of the literature.

    Chapter 4 analyses how survey has been done

    Chapter 5 represent the results

    Chapter 6 discuss the finding of the survey

    Chapter 7 making conclusion on survey findings

    Chapter 8 explains how can further study be done in this field.

    Chapter 2

    METHODOLOGY

    2.1 Introduction

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    This chapter elaborates how the research study was carried out .It also talks about the limitation of the research and methods used in this research.

    When the writer was studying the module of Quality Management Systems (QMS),writer developed his mind initially of doing the project in QMS. The writer discussed this with the supervisor and writer was encouraged by the supervisor. The writer started the research about different kind of quality systems specially about ISO 9000.

    2.1.1 Ideas

    The writer started the project as the studying different kind of quality management systems. During that study writer got many ideas but he was not much confident that what to do. So he went to supervisor and discussed the situation with him. Then writer decide to do the comparisons between the different kind of quality management systems.

    2.1.2 Choosing Specific Industry

    While going through the literature review, writer came to know that there are different QMS in different industries. The writer has to choose one industry to go in more details and in more specific. So writer initially decide to investigate about the electrical instrument manufacturing industry. The writer went to supervisor to talk about it. But during that discussion writer analysed the situation and feel that it is going to be very difficult to study about electrical manufacturing industry as writer have not background in that field and have not much knowledge about it. So the writer decides in pharmaceutical industry. As there is not much work done of QMS in that industry.

    In order to gain adequate knowledge and clear understanding of the topic, sufficient information was gathered through internet, books and journals.

    During that writer studied that pharmaceutical industry use ISO 9000 and Good Manufacturing Practice (GMP) quality systems. So the writer starts more research about these systems. Writer started learning more about the ISO 9000 clauses. The write also study that GMP as QMS. The writer also researched about the relationship between ISO 9000 and GMP.

    Having discussion with supervisor writer make 6 objectives for the project.

  8. What is QMS
  9. To define QMS and types of QMS, like ISO 9001 and DEMING ,BALRIDGE ,GMP
  10. Defining the clauses of ISO series
  11. To identify Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7
  12. To identify how Pharmaceutical get benefit from QMS
  13. To identify how pharmaceutical can be improved by QMS

2.1.3Questionnaire

As writer aims to find out that which kind of Quality Management Systems are used in pharmaceuticals and how these are used, writer decided to do a survey type of questionnaire. To do questionnaire survey writer searched the internet to find out the pharmaceutical companies which can be possible target. To do survey first the writer decided to do online survey but later he find out that it is going to be difficult as companies are less responsive to do that. So he decide to do postal survey. He developed a questionnaire with the help of supervisor.

The overall aim of the study was achieved under the six objectives under the following 2 methods

Necessary information was collected by doing literature review. Literature review was carried using past research papers, books, journals and articles about Quality Management Systems(QMS) in pharmaceutical.

Survey questionnaire helped to gather current and practical information. Prepared questionnaires were sent out to pharmaceutical companies in the UK. There response were analysed statistically

2.2 literature review

The literature review provides necessary knowledge base to build up the project. It starts with the information gathering to understand the background topic concerned. The main resources of the literature review were from books and journals of the library and from the internet. As for as the selected topic is concerned, internet is better choice for collecting information as it provide more updates information

Studying the literature provided various advantages.

Helped to understand the definitions, theories and past studies.

Helped to know about other studies on this topic and provided broader knowledge about topic.

Facilitated identifying the gap between the current study and the past study of the project.

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The review would represent the research carried out by the others

2.3 Survey Questionnaire

Questionnaire used as another technique for collecting information. Supervisor assisted to modify and amend the questionnaire prepared by the writer.

CHAPTER 3

THEORY

3.1 QUALITY IN GENERAL

From a long time, a lot of theories and definitions are written about the quality and methods involving quality. Many authors and scientists write about quality. B.G.Dale(B.G.Dale,"Developing, Introducing and Sustaining TQM", 2004) also write a book about total quality which is consider through out the world. The following chapter is mainly extract from the B.G.Dale book and my own views.

Quality has many meanings, ranging from luxury and merit to excellence, good value for money or convenience and even practicality. It is often defined simply as 'fitness for purpose'. Quality is a multi-faceted concept; different dimensions of quality will be important to different users.

In today's global competitive marketplace the demands of customers are for ever increasing as they require improved quality of products and services. Also, in some markets there is an increasing supply of competitively priced products and services from low labour cost countries such as those in the Far East, the former Eastern bloc, China, Vietnam and India. Continuous improvement in total business activities with a focus on the customer throughout the entire organization and an emphasis on flexibility and quality is one of the main means by which companies face up to these competitive threats.

This is why quality and its management and the associate continuous improvement are looked upon by many organizations as the means by which they can survive in increasingly aggressive markets and maintain a competitive edge over their rivals. The companies that do not manage this change will fail. As a result of the efforts made by organizations to respond to these marketplace demands the quality of products, services and processes has increased considerably during the last two decades. Feigenbaum and Feigenbaum (1999) point out that:

Total Quality is a major factor in the business quality revolution that has proven itself to be one of the 20th century's most powerful creators of sales and revenue growth, genuinely good new jobs, and soundly based and sustainable business expansion.

Having said this, it should be pointed out that in many markets today quality, narrowly defined as the reliability of product and service quality, is not the competitive weapon it once was. It is now expected as a given requirement and is considered an entry-level characteristic to the marketplace.

What is Quality?

'Quality' is now a familiar word. However, it has a variety of interpretations and uses, and there are many definitions. Today and in a variety of situations it is perhaps an over-used word. For example, when a case is being made for extra funding and resources, to prevent a reduction in funding, or to keep a unit in operation and in trying to emphasize excellence, just count the number of times the word 'quality' is used in the argument or presentation.

Many people say they know what is meant by quality, they typically claim 'I know it when I see it' (i.e. by feel, taste, instinct and/or smell). This simple statement and the interpretations of quality made by lay people mask the need to define quality and its attributes in an operational manner. In fact, quality as a concept is quite difficult for many people to grasp and understand, and much confusion and myth surround it.

In a linguistic sense, quality originates from the Latin word 'qualis' which means 'such as the thing really is'. There is an international definition of quality, the 'degree to which a set of inherent characteristics fulfils requirements' (BS EN ISO9000 (2000)).

In today's business world there is no single accepted definition of quality. However, irrespective of the context in which it is used, it is usually meant to distinguish one organization, event, product, service, process, person, result, action, or communication from another. For the word to have the desired effect as intended by the user and to prevent any form of misunderstanding in the communication, the following points need to be considered:

The person using the word must have a clear and full understanding of its meaning.

The people/audience to whom the communication is directed should have a similar understanding of quality to the person making the communication.

Within an organization, to prevent confusion and ensure that everyone in each department and function is focused on the same objectives, there should be an agreed definition of quality. For example, Betz Dearborn Ltd. Define quality as: 'That which gives complete customer satisfaction', and Rank Xerox (UK) as 'Providing our customers, internal and external, with products and services that fully satisfy their negotiated requirements'. North-West Water Ltd. uses the term 'business quality' and defines this as:

Understanding and then satisfying customer requirements in order to improve our business results.

Continuously improving our behaviour and attitudes as well as our processes, products and services.

Ensuring that a customer focus is visible in all that we do. There are a number of ways or senses in which quality may be defined, some being broader than others but they all can be boiled down to either meeting requirements and specifications or satisfying and delighting the customer. These different definitions are now examined.

Qualitative

When used in this way, it is usually in a non-technical situation. BS EN ISO9000 (2000) says that 'the term "quality" can be used with adjectives such as poor, good or excellent'. The following are some examples of this:

In advertising slogans to assist in building an image and persuade buyers that its production and services are the best: Esso - Quality at Work; Hayfield Textiles - Committed to Quality; Kenco - Superior Quality; Philips Whirlpool - Brings Quality to Life; Thompson Tour Operations - Thompson Quality Makes the World of Difference.

By television and radio commentators (a quality player, a quality goal, a quality try). By directors and managers (quality performance, quality of communications).By people, in general (quality product, top quality, high quality, original quality, quality time, quality of communications, quality person, loss of quality, German quality, 100 per cent quality).

It is frequently found that in such cases of 'quality speak' the context in which the word quality is used is highly subjective and in its strictest sense is being misused.

For example, there is more than one high street shop which trades under the name of 'Quality Seconds', and there is even a shop which advertises under the banner of 'Top Quality Seconds'. A van was recently spotted with the advertising slogan 'Quality Part-Worn Tyres' on its side.

Quantitative

The traditional quantitative term which is still used in some situations is acceptable quality level (AQL). This is defined in BS4778 (1991) as: 'When a continuing series of lots is considered, a quality level which for the purposes of sampling inspection is the limit of a satisfactory process'. This is when quality is paradoxically defined in terms of non-conforming parts per hundred (i.e. some defined degree of imperfection).

An AQL is often imposed by a customer on its supplier in relation to a particular contract. In this type of situation the customer will inspect the incoming batch according to the appropriate sampling scheme. If more than the allowed numbers of defects are found in the sample the entire batch is returned to the supplier or the supplier can, at the request of the customer, sort out the conforming from nonconforming product on the customer's site. The employment of an AQL is also used by some companies under the mistaken belief that trying to eliminate all defects is too costly.

The setting of an AQL by a company can work against a 'right first time' mentality in its people as it appears to condone the production and delivery of nonconforming parts or services, suggesting that errors are acceptable to the organization. It is tantamount to planning for failure. For example, take a final product which is made up of 3,000 parts: if the standard set is a 1 per cent AQL, this would mean that the product is planned to contain 30 non-conforming parts. In all reality there are likely to be many more because of the vagaries of the sampling used in the plan or scheme, whereby acceptance or rejection of the batch of product is decided.

3.2 QUALITY MANAGEMENT SYSTEMS(QMS)

A report was published from Department of trade and industry UK in 2007 which explain the basic concepts of Quality management systems (QMS).The following chapter is build on the points which is given in that report.

An organisation will be benefit from establishing an effective quality management systems(QMS).The basic concept is the customer and supplier working together for their mutual benefit. For this purpose the customer and supplier relation go beyond boundary.

A QMS can be defined as " A set of co-ordinate activities to direct and control an organisation in order to continually improve the effectiveness and efficiency of its performance ".

These activities interact and are affected by being in the systems ,so the isolation and study of each one in detail will not necessarily lead to an understanding of the systems as whole.The main thrust of a QMS is defining the processes ,which will result in the production of quality products and services ,rather than in detecting products or services after they have been produced.

The benefits of a QMS

QMS will ensure that these two requirement are met:

The customers' requirements - confidence in the ability of the organisation to deliver the desired product and service consistently meeting their needs and expectations.

The organisation's requirements - both internally and externally, and at an optimum cost with efficient use of the available resources - materials, human, technology and information.

These requirements can only be met if objective is provided ,in the form of information and data .to support the systems activities ,from the ultimate supplier to the ultimate customer .

An organisation having QMS can achieve the goals and objectives set out in its policy and strategy .This will provide consistency and satisfaction in terms of methods ,materials ,equipment and ending with their satisfaction ,at every transation interface

Quality management systems are needed in all areas of activity, whether large or small business,manufacturing ,service or public sector

A good QMS will

  • Set direction and meet customers' expectations
  • Improve process control
  • Reduce wastage
  • Lower costs
  • Increase market share
  • Facilitate training
  • Involve staff
  • Raise morale

In a survey conducted by the Defence Evaluation Research Agency (DERA), ca.96% of respondents said they believed their systems contributed to meeting the business goals. However, ca. 72% responded that their organisation did not measure this contribution.

3.2.1 QMS AND International Organization for Standardization (ISO)

ISO is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is carried out through ISO technical committees, in liaison with international organisations, governmental and non-governmental bodies. ISO's most recent family of standards for quality management systems are currently in their final draft (FDIS) form, and comprises:

  • ISO/FDIS 9000:2000 - Quality management systems - Fundamentals and vocabulary
  • ISO/FDIS 9001:2000 - Quality management systems - Requirements
  • ISO/FDIS 9004:2000 - Guidelines for performance improvement

They are built around business processes, with a strong emphasis on improvement and a focus on meeting the needs of customers. The new standards originated from a regular six year review and are intended to be generic and adaptable to all kinds of organisations.

The ISO 9002 and ISO 9003 are to be discontinued (but can still be used by those organisations certified against them during the three year transition period), and ISO 9001and ISO 9004 are designed to be used together, but can be used independently.

The ISO Series can form the means by which a holistic management system can be implemented, into which quality, health and safety and environmental responsibility can be integrated, with the audits carried out either separately or in combination.

3.2.2 ISO 9001

ISO 9001 specifies the requirements for QMS that may be used by organisations for internal application, certification or contractual purposes.

The approach is shown in the conceptual model from the ISO 9000 standard

The major clauses and sub-clause are:

  • Scope
  • Normative reference
  • Terms and definitions
  • Quality management system
  • General requirements

    Documentation requirements

  • Management responsibility
  • Management commitment
  • Customer focus
  • Quality policy
  • Planning
  • Responsibility, authority and communication
  • Management review
  • Resource management
  • Provision of resources
  • Human resources
  • Infrastructure
  • Work environment
  • Product realisation
  • Planning of product realisation
  • Customer-related processes
  • Design and/or development
  • Purchasing
  • Production and service operations
  • Control of measuring and monitoring devices
  • Measurement, analysis and improvement
  • General
  • Planning
  • Monitoring and measurement
  • Control of non-conforming product
  • Analysis of data
  • Improvement

The management system requirements under these clauses are specified in more detail in the ISO 9001 Standard.

Setting up a QMS

For organisations to function effectively, they have to identify and manage numerous interlinked, cross-functional processes, always ensuring customer satisfaction is the target that is achieved. The schematic illustrates this concept:

The adoption of a QMS needs to be a strategic decision of an organisation, and is influenced by varying needs, objectives, the products/services provided, the processes employed and the size and structure of the organisation. A QMS must ensure that the products/services conform to customer needs and expectations, and the objectives of the organisation. Issues to be considered when setting up a QMS include its:

  • Design
  • Build
  • Control
  • Deployment
  • Measurement
  • Review
  • Improvement

Taking each of these in turn:

Design and build includes the structure of the quality management system, the process and its implementation. It's design must be led by senior managers to suit the needs of the organisation, and this is ideally done using a framework to lead the thinking. Design of the QMS should come from determining the organisation's core processes and well-defined goals and strategies, and be linked to the needs of one or more stakeholders.

The process for designing and building the QMS must also be clear, with the quality function playing a key role, but involvement and buy-in to the system must also come from all other functions.

Deployment and implementation is best achieved using process packages, where each core process is broken down into sub-processes, and described by a combination of documentation, education, training, tools, systems and metrics. Electronic deployment via Intranets is increasingly being used.

Control of the QMS will depend on the size and complexity of the organisation. ISO is a site-based system, and local audits and reviews are essential even if these are supplemented by central reviews.

Local control, where possible, is effective, and good practice is found where key stakeholders are documented within the process and where the process owner is allowed to control all of the process. Ideally, process owners/operators are involved in writing procedures.

Measurement is carried out to determine the effectiveness and efficiency of each process towards attaining its objectives. It should include the contribution of the QMS to the organisation's goals; this could be achieved by measuring the following

  • Policy definition completeness
  • Coverage of business
  • Reflection of policies
  • Deployment
  • Usage
  • Whether staff find the QMS helpful in their work
  • Speed of change of the QMS
  • Relevance of QMS architecture to the job in hand

A form of scorecard deployed through the organisation down to individual objective level can be employed, and the setting of targets at all levels is vital.

Review of the effectiveness, efficiency and capability of a QMS is vital, and the outcome of these reviews should be communicated to all employees. Reviewing and monitoring should be conducted whether or not improvement activities have achieved their expected outcomes.

Improvement should follow as a result of the review process, with the aim of seeking internal best practice. It is part of the overall improvement activities and an integral part of managing change within the organisation.

ISO 9000 contains eight quality management principles, upon which to base an efficient, effective and adaptable QMS. They are applicable throughout industry, commerce and the service sectors:

  • Customer focus
  • Leadership
  • Involving people
  • Process approach
  • Systems approach
  • Continual improvement
  • Factual decision making
  • Mutually beneficial supplier relationships

Taking each one in turn, they are explained more fully as:

An effective QMS must ensure that the organisation has a strong Customer Focus. Customer needs and expectations must be determined and converted into product requirements.

Top management have to demonstrate Leadership. Providing unity of purpose through an appropriate quality policy, ensuring that measurable objectives are established, and demonstrating that they are fully committed to developing, sustaining and improving the QMS.

Managers must ensure that there is Involvement of People at all levels in the organisation. This includes ensuring that there is an awareness of the importance of meeting customer requirements and responsibilities in doing this, and people are competent, on the basis of appropriate training and experience.

An effective QMS must be a strategic tool designed to deliver business objectives, and must have, at its core, a Process Approach, with each process transforming one or more inputs to create an output of value to the customer. The key business processes may be supported by procedures and work instructions in those cases where it is judged necessary to rigidly define what rules are to be followed when undertaking a task. Most organisations will have core business processes that define those activities that directly add value to the product or service for the external customer, and supporting processes that are required to maintain the effectiveness of the core processes.

The understanding of the many interrelationships between these processes demands that a Systems Approach to management is adopted. System approach basically depend upon the different companies that which kind of QMS they are adopted in which how management approach certain things. The processes must be thoroughly understood and managed so that the most efficient use is made of available resources, to ensure that the needs of all the stakeholders - customers, employees, shareholders and the community - are met.

Customer satisfaction is a constantly moving entity depending on changes in technology and the market place, so an effective QMS must be in a state of Continuous Improvement. For this to be achieved, attention needs to be given to both the voice of the customer - through complaint analysis, opinion surveys and regular contacts - and the voice of the processes - through measurement, monitoring and analysis of both process and product data. This will result in Factual Decision Making.

Each organisation is itself only a link in the chain of a larger raw material process, and for the long term needs of the community and the organisation there needs to be Mutually Beneficial Supplier Relationships. Audits, reviews and assessments.

A good QMS will not function or improve without adequate audits and reviews.

Audits are carried out to ensure that actual methods are adhering to the documented procedures, whilst system reviews should be carried out periodically and systematically, to ensure the system achieves the required effect.

There should be a schedule for carrying out audits, with different activities possibly requiring different frequencies. An audit should not be conducted just with the aim of revealing defects or irregularities - they are for establishing the facts rather than finding faults. Audits do indicate necessary improvement and corrective actions, but must also determine if processes are effective and that responsibilities have been correctly assigned. The emphasis on process improvement and enhancing customer satisfaction in the revised standard will require a more thoughtful approach to auditing.

The generic steps involved in ISO 9000 are:

  • Initiation
  • Scope

    Frequency

  • Preparation
  • Review of documentation

    The Programme

    Working documents

  • Execution
  • Opening meeting

    Examination and evaluation

    Collecting evidence

    Observations

    Close the meeting with the auditee

  • Report
  • Preparation

    Content

    Distribution

  • Completion

Report

Submission

Retention

A quality management system review should take place, possibly once a year, which should cover:

  • Results of audits
  • Customer feedback
  • Process and product conformity
  • Status of preventative and corrective actions
  • Follow up actions from previous management reviews
  • Changes that could effect the QMS
  • Recommendations for improvements

Outputs should include:

  • Improvements to the QMS and processes
  • Improvements of a product related to customer requirements
  • Resource needs

In addition, the procedures for conducting audits and reviews and the results from them should be documented, and also be subject to review. Internal system audits and reviews should be positive and conducted as part of the preventative strategy, and not as a matter of expediency resulting from problems.

The assessment of a quality system against a standard or set of requirements by internal audit and review is known as a first-party assessment or approval scheme. If an external customer makes the assessment of a supplier, against either its own, or a national or international, standard, a second-party scheme is in operation. The assessment by an independent organisation, not connected with any contract between the customer and supplier, but acceptable to them both, is an independent third-party assessment scheme.

The latter usually results in some form of certification or registration by the assessment body.

For third-party certification schemes to be of value they need to be backed by accreditation. In the U.K., the United Kingdom Accreditation Service (UKAS) is recognised by the Government as the sole national accreditation body for this purpose. UKAS accredits certification bodies by evaluating their competence against international standards.

An advantage of third-party certification, when backed by accreditation, is the assurance that it provides to customers that obviates the requirements for their own detailed checks but in addition it enables the certified organization to use the renowned national accreditation mark to denote this assurance, thus improving its competitiveness. Companies using the accredited certification bodies can also be included in the Stationery Office's publication which lists quality assured companies, the QA Register.

All managers, not just the staff in the "quality department", need to be fully committed to operating an effective quality management system for all the people within the organisation. The system must be planned to be effective and achieve its objectives in an uncomplicated way. It should also not be static, but be flexible, to enable constant seeking of improvements.

3.2.3 The Deming Prize

The Deming Prize is Japan's national quality award for industry. It was established in 1951 by the Japanese Union of Scientists and engineers (JUSE) and it was named after W. Edwards Deming. He brought statistical quality control methodology to Japan after W.W.II. The Deming Prize is the world's oldest and most prestigious of such awards. Its principles are a national competition to seek out and commend those organizations making the greatest strides each year in quality, or more specifically, TQC. The prize has three award categories. They are Individual person, the Deming Application Prizes, and the Quality Control Award for factory. The Deming Application prizes are awarded to private or public organizations and are subdivided into small enterprises, divisions of large corporations, and overseas companies. There are 143 companies who won the prize. Among them, only once has the Deming Prize been awarded to a non-Japanese company: Florida Power and Light in 1989.

Sue Rohana and David Luthy(2001) published a report which explain the check list of Deming Award, Baldrige Award and comparison between Deming and Baldridge Award.

3.2.4 Baldrige Award

The Baldrige Award was established in 1987 to promote quality awareness, understand the requirements for quality excellence, and share information about successful quality strategies and benefits. There are three eligibility categories: manufacturing, services, and small firms. Unlike the Deming Prize, public or not-for-profit organizations are not qualified. Also, there is no category in which all applicants that satisfy a given level of performance receive a quality prize. Since its foundation, there are only five companies who received this prize. According to its principles, the role of quality data collection and analysis as the basis for managerial decisions is paramount. Furthermore, quality efforts should not concentrate only on the elimination of defects but also encompass creative activities that will influence customer satisfaction. Among Baldrige winners, there are no service companies.

3.3 ISO 9000 IN PHARMACEUTICAL

Increased safety in drug administration and continuous monitoring of the quality of clinical and research process is necessary in medical oncology, but to our knowledge no medical oncology unit in Europe has yet planned or achieved certification .In Europe the quality accretion systems is mainly provided through ISO 9001/2000 VISION.

Pharmaceutical manufacturers have the responsibility of developing safe production through the proper selection of ingredients, product formulation add safety substantiation. They are also responsible for the quality of the raw materials they purchase .In the current climate, understanding only raw material science will not be enough .Suppliers will need to integrate environment impact with the pharmaceutical industry in order to build the proper level of controls into their manufacturing and distribution practices

These trends become increasingly important as pharmaceutical companies require improved Good Manufacturing Practice (GMP) expectations from their suppliers due to greater regulatory demand for safe products throughout the entire supply chain. Price pressures from competition and cheap sources of material of questionable quality also need to be considered.

While going trough the literature the writer learn that in the drug manufacturing, there are 2 types on ingredients involve, One which is active and one which in non active. The active ingredients are those which are according to formula of the drug. The other which are non active are excipients.

The writer is going to use excipients as an example because it is a commodity market and also these are bought in from market as raw material.

The pharmaceutical industry is ever thirsty to satisfy patient's therapeutical needs and apart from active ingredients, inactive excipients play a major role in formulation development. Pharmaceutical excipients are substances other than the pharmacologically active drug or prodrug which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form.

In addition to transporting the active drug to the site in the body where the drug is intended to exert its action, excipients play an important part in the manufacturing process. They may also be important for keeping the drug from being released too early in the assimilation process in places where it could damage tender tissue and create gastric irritation or stomach upset

Lot of time and effort are still needed in field of excipients. However till then a formulation scientist is entrusted with the limited amount of excipients.

Pharmaceutical excipients(Pharmaceutical excipients are substances - other than the active pharmaceutical ingredient - that are used in the finished dosage form.) inactive ingredients that when combined with active pharmaceutical ingredients ,produce a drug dosage from typically make up about 99% of a finished drug product .These excipients are derived from various sources (natural ,biological and chemical etc) and can be targeted for use in variety of products intended for very diverse business .Their role in pharmaceutical products can be vary from non critical to highly sophisticated ,depending on the drug and dosage from design.

Today most countries worldwide have requirements for reviewing and approving pharmaceutical products, or are currently working to establish them in order to ensure product quality ,safety and traceability, however current legislation are targeted mainly at regulating compliance for APIs[3] and finished pharmaceutical products.

Currently, control of excipient manufacturing and distribution is not a key priority for regulatory authorities or pharmaceutical manufacturers, perhaps due to the fact that most of these excipients originated from the food industry and have Generally Recognised As Safe (GRAS) status .However, with the emergence of excipients and delivery systems, better control of these materials becomes increasingly important.

In general excipients have not been a major source of concern. However , even today examples exist where identified issues may been minimised or eliminated using better control of the essential elements of GMPs.

For example near 100 deaths resulted from cough syrup that was contaminated with diethylene glycol according to the World Health Organization WHO.

The current trend is to use risk management as foundation for defining the appropriate level of GMPS. Caution should be taken when using these tools since they involve a complete understanding of the end -use applications.

This situation becomes much more complex when distributors and brokers are involved.

Defining a standard that would be applicable universally to all types of excipients may be impossible . However an effort to assist the pharmaceutical manufacturers in developing a set of GMP guidelines targeted at excipients ,both the international PHARMCEUTICAL Excipients council and WHO have published GMP guidelines for bulk pharmaceutical excipients. These guidelines target understanding and implementing the key principles of GMPs such as

  • Documentation and traceability
  • Change control and customer notification
  • Contamination control

Addressing these needs in an affordable manner is just as important as delivering the critical principles noted .Thus, a balanced approach must be used when establishing key GMP rules.

Because of the diverse nature of excipients, it is expected the the foundation for the excipients industry would be based on International Organization for Standardization (ISO) quality standards.Although ISO standard guidelines provide a valuable framework for quality systems ,they focus mainly on the what rather than the how Quality improvements are seen in the excipients industry as way of life ,however those improvements may lead to changes that might have an impact on downstream products and delivery systems .Suppliers of raw materials and components of drug manufacturer would receive ,including a mechanism to notify pharmaceutical manufacturers of significant change .

3.4 Methods of developing ISO 9000 in pharmaceutical Or Integrating GMP into ISO

Because the pharmaceutical industry has traditionally focused upon the application of Good Manufacturing Practice (GMP), it has been slow to consider the potential benefits to be gained by implementing an EN ISO 9001 Quality Management System (QMS).

Over the last few years the global pharmaceutical market has undergone significant change, forcing pharmaceutical companies, more than ever before, to focus on customer needs and upon their own internal efficiency in order to continue to compete effectively.

With this in mind CEFIC commissioned a working group of experts drawn from several major Active Pharmaceutical Ingredients (API) producers to prepare a practical, user-friendly guidance document integrating current GMP requirements into the EN-ISO 9001 QMS framework. To achieve this the working group have taken relevant features from the August 1996 CEFIC/EFPIA publication "Good Manufacturing Practice for Active Ingredients Manufacturers" and combined these with the relevant complementary requirements of EN-ISO 9001 "Quality Systems: Model for quality assurance in design, development, production, installation and servicing". It is intended that these Guidelines are applicable to all APIs.

However, in the case of a sterile API , the Guidelines should be applied at least to the point at which the API enters a sterilising process.

To facilitate understanding of this composite guidance document it is important for the reader to be aware of the following points:

3.4.1 Difference Between ISO and GMP

  • EN-ISO 9001 is a generic, business focused, standard which supports the effective management of quality to an internationally recognised level of best practice. It is flexible in that it specifies what is to be achieved, but allows each company freedom to determine, and justify, how these requirements are achieved. In contrast, GMP is an industry-specific standard prescribing what must be done to ensure product safety and efficacy. Thus, EN-ISO 9001 benefits the business by ensuring the quality of the management system, while GMP ensures that regulatory requirements are met.
  • Although there is inevitably some overlap between the requirements of a QMS and GMP they are, in fact, highly complementary. This view is supported by a statement in the introduction to the PIC (International Inspection Convention) GMP Guideline which refers to "....... a correctly implemented system of Quality Assurance incorporating GMP .......", and by the wording of the introduction in ISO itself which points out that "....... this international standard is complementary - not alternative - to the technical (product) specified requirements".

To be effective the QMS should have the visible and ongoing support of top management.

To fully benefit the company the QMS should involve all staff whose activities influence quality, have a clear and unambiguous continuous improvement focus, and incorporate relevant, realistic performance measures with emphasis on reducing failure costs, and satisfying (internal and external) customer needs.

The quality manual occupies the highest level in the document hierarchy. It overviews and acts as a directory to the QMS, capturing the unique character of the company.

An effective QMS has a minimum of paperwork, and should constantly question the need for the existing documents. In contrast, a bureaucratic and inefficient QMS will arise if the Standard is misinterpreted, and incorrectly applied.

In document(EN-ISO 9001), the original EN-ISO 9001 subclauses have been addressed in twenty distinct chapters supplemented by four annexes in recognition of the importance of issues concerning hygiene; facilities and utilities; validation; and change control, to the API industry. Each chapter and each of the four annexes are structured in a way which summarises the appropriate QMS principle and philosophy as a preface to the main text which integrates relevant GMP requirements and QMS principles. The rationale/justification and business benefits of a combined QMS/GMP approach are considered Safety, health and environment are not specifically addressed. However, it is widely acknowledged that implementation of a robust QMS provides a sound basis for the future development of such an Integrated Management System.

"In EN-ISO 9001 the term "should" indicates requirements that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance."

Chapter 4

4.1 Previous Work of ISO 9000 in Pharmaceutical

Since people began working with formal routines and Quality Management Systems, there have been efforts trying to observe how these are used in the everyday work. One would believe that the widespread use of web based tools may have increased the usage of such systems, since information now is a lot more available in the work situation. One could also believe that the stronger competition for market shares in the pharmaceutical industry would lead to the need of formal routines to ensure the quality and effectiveness of the companies. This section will look at some of the previous work done in this field.

4.2 Formal Routines for Quality in Pharmaceutical

Before the start usage of ISO 9000 in pharmaceutical, most of the companies use the GMP (Good manufacturing practices).

The ICH Q10(International Conference on Harmonisation of Technical Requirement for Registration of Pharmaceuticals for Human use)document on Pharmaceutical Quality System was adopted at Step 4 at the ICH Steering Committee meeting in June 2008. The next stage is formal adoption in the EU.

By virtue of Art. 6 of Directive 2003/94/EC and Directive 91/412/EEC manufacturers in the EU are obliged to establish and implement an effective pharmaceutical quality assurance system in order to comply with Good Manufacturing Practice (GMP). Guidance is provided in the GMP Guide. ICH Q10 provides an example of a pharmaceutical quality system designed for the entire product lifecycle and therefore goes beyond current expectations. It should be noted that ICH Q10 is optional but its use should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

Work is currently underway to determine the most appropriate way to adopt ICH Q10 into the European regulatory system.

4.3 PHARMACEUTICAL QUALITY SYSTEM

This establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term "pharmaceutical quality system" refers to the ICH Q10 model.

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 "Pharmaceutical Development" and ICH Q9 "Quality Risk Management". ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

ICH Q10 demonstrates industry and regulatory authorities' support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological products, throughout the product lifecycle.

The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage.

For the purposes of this guideline, the product lifecycle includes the following technical activities for new and existing products:

  • Pharmaceutical Development
  • Drug substance development;

    Formulation development (including container/closure system);

    Manufacture of investigational products;

    Delivery system development (where relevant);

    Manufacturing process development and scale-up;

    Analytical method development

  • Technology Transfer
  • New product transfers during Development through Manufacturing;

    Transfers within or between manufacturing and testing sites for marketed products.

  • Commercial Manufacturing
  • Acquisition and control of materials;

    Provision of facilities, utilities, and equipment;

    Production (including packaging and labelling);

    Quality control and assurance;

    Release;

    Storage;

    Distribution (excluding wholesaler activities).

  • Product Discontinuation

Retention of documentation;

Sample retention;

Continued product assessment and reporting.

Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7

GMP requirements, the ICH Q7 Guideline, "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients", and ISO quality management system guidelines form the foundation for ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities. ICH Q10 provides a harmonised model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements.

The GMPs do not explicitly address all stages of the product lifecycle (e.g., Development). The quality system elements and management responsibilities described in this guideline are intended to encourage the use of science and risk based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle.

Relationship of ICH Q10 to Regulatory Approaches

Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site.

ICH Q10 Objectives

Implementation of the Q10 model should result in achievement of three main objectives which complement or enhance regional GMP requirements are given below

1Achieve Product Realisation

To establish, implement and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers.

2 Establish and Maintain a State of Control

To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems.

3 Facilitate Continual Improvement

To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil quality needs consistently. Quality risk management can be useful for identifying and prioritising areas for continual improvement.

This diagram illustrates the major features of the ICH Q10 Pharmaceutical Quality System (PQS) model. The PQS covers the entire lifecycle of a product including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation as illustrated by the upper portion of the diagram. The PQS augments regional GMPs as illustrated in the diagram. The diagram also illustrates that regional GMPs apply to the manufacture of investigational products. (ICHQ 10 2008)

The next horizontal bar illustrates the importance of management responsibilities to all stages of the product lifecycle. The following horizontal bar lists the PQS elements which serve as the major pillars under the PQS model. These elements should be applied appropriately and proportionally to each lifecycle stage recognising opportunities to identify areas for continual improvement.

The bottom set of horizontal bars illustrates the enablers: knowledge management and quality risk management, which are applicable throughout the lifecycle stages. These enablers support the PQS goals of achieving product realisation, establishing and maintaining a state of control, and facilitating continual improvement.

Enablers: Knowledge Management and Quality Risk Management

Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the objectives described

1Knowledge Management

Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.

2 Quality risk Management

Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

Design and Content Considerations

  • The design, organisation and documentation of the pharmaceutical quality system should be well structured and clear to facilitate common understanding and consistent application.
  • The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the different goals and knowledge available for each stage.
  • The size and complexity of the company's activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspects of the pharmaceutical quality system can be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level.
  • The pharmaceutical quality system should include appropriate processes, resources and responsibilities to provide assurance of the quality of outsourced activities and purchased materials.

Quality Manual

A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include:

  • The quality policy
  • The scope of the pharmaceutical quality system;
  • Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner.
  • Management responsibilities within the pharmaceutical quality system [4]

Chapter 5

Research plan

This chapter will elaborate how I wish to focus my empirical studies. I present the research questions which are the base of the studies. I then present how I intend to evaluate the answers.

5.1 Research Theory (Hypothesis)

Companies performing Pharmaceutical Development (PD) have, the last ten-fifteen years, investeda lot of resources, both financial and manpower to develop formal Quality ManagementSystems (QMS) to ensure quality of the developed Drugs.

Do developers in these companies react negatively and rely on their own judgment and experience? Is there a gap between how management and developers look at QMS? Does a QMS improve the quality of the systems, or is it just an obstacle for effective work progress? Is there any conflict between the informal formalised and the practical use part of the QMS mentioned ? Do formal certifications like ISO 9001 and DEMING ,BALRIDGE ,EFQM support and encourage developers to use the QMS. These questions are the foundation of my survey

5.1.1 Research method

The work in this project is performed as a qualitative survey which targeted a random sample of UK pharmaceutical companies with research development activity .The layout of the survey based on maturity grid which indicates the stages on the path to achieving TQM, ranging from uncertainty to certainty.

The aims of the study is as follows

  • To determine the quality methodology adopted in the pharmaceutical industry.
  • To determine the total time taken for the implementation of quality processes(i.e. two years ,five years or longer ) in order to obtain a figure for the resources directed to quality training and development
  • To obtain an estimate of the total costs involved in TQM implementation.
  • To determine the numbers of staff actually involved and different types of training programmes implemented.
  • To determine which of company wide or departmental implementation provides the greatest benefit.
  • To determine the effect of TQ to the organization climate, in terms of, for example, morale, quality, of work life.
  • To determine how staff is rewarded, and how good work is recognized.
  • To identify any practical recommendations that the quality managers recommend for implementing TQM.

5.2 Questions used in the Survey

Here I present the questions used during the survey. I focus more on the support the QMS gives to the work of the developers. My questions are developed to give answers to the research questions.

How the research questions are mapped to these questions is described when presenting the questions. In addition to the questions Q1-Q10, it is necessary with some general questions about the company and it's structure, size etc.

5.2.1 What kinds of routines exist?

This group of questions is mainly to get an idea of how well the employees know their own company, and how aware they are of what sorts of routines that exists. It also aims to find out how newly employed personnel are trained in the use of the QMS and if they see the training as useful and adequate. All these questions are pretty general, but also gives some important answers towards mapping the attitudes.

Q1. Is this company certified or assessed after any formal standards? ISO 9001

Q2. In this company if TQM is applied ,is that applied departmentally or corporately?

Q3. How many employees work in this company?

Q4. From how long TQM has been implementing in this company?

I categorize the companies into following categories based on Q1:

  • Not certified/acknowledged
  • ISO9001:2000 certified
  • GMP certified
  • GLP-acknowledged
  • Other certification or acknowledgement

These five categories covers the most frequently used formal assessments. This categorization says little about those companies that doesn't have a formal certification or acknowledgment, but may show something about how many of the companies today that finds this kind of formalization relevant. I also want to see what kind of technology or method that was being used to represent the QMS, and have made two categories for Q2:

  • Departmentally
  • Corporately