Module 2 | Slide 1 of 19 January 2006

Quality Management

Basic Principles of GMP

Section 1 and 2

Module 2 | Slide 2 of 19 January 2006

Quality Management

Objectives

To understand key issues in quality assurance/good manufacturing practices/quality control.

To understand specific requirements on quality management and quality assurance including:

Organization Procedures, processes and resources.

To develop actions to resolve your current problems.

Module 2 | Slide 3 of 19 January 2006

Section 1 and 2

Quality Management

Quality relationships

Quality Management

Quality Assurance

GMP

Production and Quality Control

Module 2 | Slide 4 of 19 January 2006

Quality Management

Quality management, – defining the overall policy of the organization towards quality, is over everything

else.

Next comes Quality assurance, – which is the concept that ensures the policy is achieved.

GMP is part of quality assurance. – It deals with the risks that cannot be tested. It builds quality into the product.

Quality control is a part of GMP. – It is that part of GMP that is focused on testing of the environment and facilities,

as well as the testing of the materials, components and product in accordance with the standard.

Module 2 | Slide 5 of 19 January 2006

Quality Management

Philosophy and essential elements

What is Quality Management?

The aspect of management function that determines and implements the “quality policy”

The overall intention and direction regarding quality, as formally expressed and authorized by top management

Module 2 | Slide 6 of 19 January 2006

Quality Management

Philosophy and essential elements

The quality policy is a statement by the top management of the company of its overall intentions and direction relating to quality,

formally expressed as a corporate policy.

The top management of a company usually includes the board of directors or general manager of the

company, the plant or factory managers together with the senior managers.

Module 2 | Slide 7 of 19 January 2006

Quality Management

Quality Management

The basic elements are:

An appropriate infrastructure or “quality system” encompassing the organization structure, procedures, processes and resources

The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality”

The totality of these actions is termed “Quality Assurance”

Module 2 | Slide 8 of 19 January 2006

Quality Management

Quality Management

Quality assurance is a management tool

In contractual situations, it also serves to generate confidence in a supplier

QA, GMP and Quality Control are interrelated aspects of Quality Management

They are described on the following slides in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products

Module 2 | Slide 9 of 19 January 2006

1.1

Quality Management

Principles of Quality Assurance (QA)

Wide-ranging concept covers all matters that individually or collectively influence the

quality of a product

Totality of the arrangements to ensure that the drug is of the right quality for the intended use

Quality Assurance incorporates GMP and also product design and development which is outside the

scope of this module

Module 2 | Slide 10 of 19 January 2006

1.1 a- d

Quality Management

QA System should ensure (1):

Products are designed and developed correctly Complying with, e.g. GMP, GCP, GLP

Production and control operations are defined

Managerial responsibilities are defined In job descriptions

The manufacture, supply and use of correct starting and packaging materials

Module 2 | Slide 11 of 19 January 2006

Quality Management

QA System should ensure (2):

Controls are performed, including intermediates, bulk, calibration and validation

Correct processing and checking of the finished product

Products are sold/supplied only after review by the authorized person Complying with marketing authorization, production and QC

requirements

Proper storage, distribution and handling 1.1 e - h

Module 2 | Slide 12 of 19 January 2006

Quality Management

QA System should ensure (3):

Procedures for self-inspection and/or quality audits

Reporting, investigation and recording of deviations

System for change control/approval

Regular evaluation of product quality to verify consistency and continued improvement

1.1 i - l

Module 2 | Slide 13 of 19 January 2006

Quality Management

QA System should ensure (3): There is a self-inspection process: available and implemented, leading

to a programme of critical self-evaluation and continuous improvement.

– A very important part of the management of the manufacturing operation is the means of auditing the operation for its compliance with all the GMP requirements.

– The auditing is done at several levels within the company.

– There should be an internal audit function within departments (self-inspection).

– This is backed up by quality audit, an independent internal organization, charged with looking at all departments and assessing the application of the quality system within a company.

Module 2 | Slide 14 of 19 January 2006

Quality Management

QA System should ensure (3): There is a self-inspection process: available and implemented,

leading to a programme of critical self-evaluation and continuous improvement.

– The ultimate auditing organization is the external auditing organization. This is normally the drug regulatory authority inspection or audit.

– Duties and responsibilities for the individual tasks need to be clearly defined and assigned to departments and individuals.

This should be done in writing. Again, this is all part of the SOP process. Every department involved in quality assurance should have SOPs that

describe its activities and who is responsible for carrying out those activities.

Module 2 | Slide 15 of 19 January 2006

1.3

Quality Management

Quality Assurance

Manufacturer is responsible for the quality of the product Fit for intended use Comply with marketing authorization Safety, efficacy and quality

Senior management and commitment of all staff

Module 2 | Slide 16 of 19 January 2006

1.3

Quality Management

Quality Assurance

Requires a comprehensively designed and well implemented QA system

Fully documented, and effectiveness monitored

Competent personnel, sufficient premises, equipment and facilities

Module 2 | Slide 17 of 19 January 2006

2.1

Quality Management

Good Manufacturing Practices (GMP)

That part of QA that ensures that products are consistently produced and controlled Quality standards Marketing authorization

Aim: Diminishing risks that cannot be controlled by testing of product Contamination and cross-contamination Mix-ups (confusion)

Module 2 | Slide 18 of 19 January 2006

Quality Management

Good Manufacturing Practices (GMP)

These risks can best be controlled by having a properly managed system of working that takes them into account. This means that:

There must be good design, sound operation, and planned maintenance of facilities.

It also means that the quality checking system must be designed with these risks in mind and set out to find whether any errors have occurred.

Let us look at this problem in another way. If we do not know what sort of cross contamination we have, then

the work of the analyst is very difficult. The analyst should ideally know what to test for before commencing testing.

In other words, if we do not know what the likely cross-contaminant is then we cannot analyse for it.

Module 2 | Slide 19 of 19 January 2006

2.1 a - c

Quality Management

Basic Requirements for GMP (1)

Clearly defined and systematically reviewed processes

Qualification and validation is performed

Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transportLaboratories and in-process control

Module 2 | Slide 20 of 19 January 2006

2.1 d - j

Quality Management

Basic Requirements for GMP (2)

Clear, written instructions and procedures

Trained operators

Records of actions, deviations and investigations

Records for manufacture and distribution

Proper storage and distribution

Systems for complaints and recalls

Module 2 | Slide 21 of 19 January 2006

Quality Management

Group session – I

How many GMP deficiencies can you find in the photographs in the handout?

Module 2 | Slide 22 of 19 January 2006

Quality Management

Group session II

Imagine you are inspecting a pharmaceutical company for compliance with GMP

Consider the situations in the next slides which may have impact on a company’s quality management programme

Describe the action to be taken in each case

Module 2 | Slide 23 of 19 January 2006

Issues – I

Quality Management manual not established in writing Limited human resources

Lack of qualified people

Processes not properly validated Poor SOPs or standard batch documentation

More consideration to cost than quality

Family members in key positions of authority

Quality Management

Module 2 | Slide 24 of 19 January 2006

Issues – II

Substandard materials deliberately purchased

Technical staff not involved in purchasing

Inability to re-export substandard materials

Owner insists on selling rejects

Corruption

No commitment to training

Quality Management