Quality management system & pharmaceuticals

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:

1) On what system(s) should a quality system be based?

2) How will the quality system’s data be managed?

3) How will the quality system’s documentation be managed?

4) What will be the KPIs (key performance indicators) of the quality system?

5) 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

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

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.

7. What is QMS

8. To define QMS and types of QMS, like ISO 9001 and DEMING ,BALRIDGE ,GMP

9. Defining the clauses of ISO series

10. To identify Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7

11. To identify how Pharmaceutical get benefit from QMS

12. 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

The table below shows how methodology

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.

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.

These days global marketplace the demands of customers are for ever increasing as they want improved quality of the products and services. In some markets there is an increasing supply of competitively priced products and services from low labour cost countries such as China, Vietnam and India. The main threats companies faces up these days are continuous improvement in total business activities with focus on the customer throughout the entire organization and an emphasis on flexibility and quality.

This why many companies are using quality management and continuous improvement as their tools to have edge over their rivals in increasingly aggressive markets. The companies that do not manage this change will fail.

Feigenbaum and Feigenbaum (1999) point out that:

Total Quality is a major factor in the business quality revolution creators of sales and revenue growth, genuinely good new jobs, and soundly based and sustainable business expansion.

Today in many markets quality still narrowly defined as the reliability of product and service quality. It is now expected an entry-level characteristic to the marketplace.

What is Quality?

Dale (2004) describes a number of different definitions of the word quality and show how it is often loosely used. For example, when case is put for funding or resources, just count the number of times the word quality is used in the argument or presentation.

While many people speak of quality and they say that they know what meaning of quality. They frequently fail to give an appropriate definition that would allow its measurement and assessment. In fact it is difficult for many people to understand the concept and definition of the quality.

“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)).”

The definition of quality is often unclear, but it is always used to indicate that one organization is better than another. Because of this the definition used at anytime should meet the following points.

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

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

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

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

5 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

The standard document 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:

There are many slogans which are used to attract the customers and buyers to buy the products 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.

For television and radio commentators use word quality like quality player, quality performance and quality goal. 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 are many high street shops which trades under the name of ‘quality seconds’. A van was recently spotted with the advertising slogan ‘Quality Part-Worn Tyres’ on its side.”

Quantitative

Quantitative definitions are required to manage quality effectively. 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).”

Some times an AQL is imposed by a customer on its supplier in relation to a particular contract. In this situation customer will inspect the batch according to the sampling scheme. If there are more number of defective items than allowed numbers, the entire batch will be returned. Some companies used AQL under the mistaken concept that trying to eliminate all the defects is too costly.

Dale (2004) describes the benefits and disadvantages of setting AQL.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.

Any company or organization will be benefit by implementation of an effective quality management system(QMS). The basic concept is customer and supplier working together for their mutual benefits. Due to this 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 “.

While studying the each one activities in the system will not help to understand the system as whole. The main purpose of the 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 requirements are met:

1 The customer requirements – confidence in the ability of the organisation to deliver the desired product and service consistently meeting their needs and expectations.

2 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 given, 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 transaction 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)

There are many models used to define and assess the performance of a company or organization, For example CMM, EFQM, Baldrige, ISO. They have many features in common and some differences. In this section I describe QMS and ISO approved.

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 basically built over the business processes, with strong focus on improvement and meeting the needs of customers. After every six years these standards are reviewed and adaptable to all kind of organizations.

ISO 9001 and ISO 9004 are designed to be used together but can also be used independently. The ISO 9002 and ISO 9003 are to be discontinued.

The ISO series make the form 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 internati