Basic Principles of GMP

Quality Management

Section 1 and 2

Module 2 | Slide 1 of 19 January 2006 STOP

 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 2 of 19 January 2006 STOP

 Quality Management
Quality relationships

Quality Management

Quality Assurance

GMP
Section 1 and 2

Production and Quality Control

Module 2 | Slide 3 of 19 January 2006 STOP

 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 4 of 19 January 2006 STOP

 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 5 of 19 January 2006 STOP

 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 6 of 19 January 2006 STOP

 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
1.1

Module 2 | Slide 7 of 19 January 2006 STOP

 Quality Management
QA System should ensure:

 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
1.1 a- d

Module 2 | Slide 8 of 19 January 2006 STOP

 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 9 of 19 January 2006 STOP

 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 10 of 19 January 2006 STOP

 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

1.3

Module 2 | Slide 11 of 19 January 2006 STOP

 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

1.3

Module 2 | Slide 12 of 19 January 2006 STOP

 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)
2.1

Module 2 | Slide 13 of 19 January 2006 STOP

 Quality Management
Basic Requirements for GMP – I

 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, transport
 Laboratories and in-process control
2.1 a - c

Module 2 | Slide 14 of 19 January 2006 STOP

 Quality Management
Basic Requirements for GMP – I

 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

2.1 d - j

Module 2 | Slide 15 of 19 January 2006 STOP

 Quality Management

Group session – I

 How many GMP deficiencies can you find in the

photographs in the handout?

Module 2 | Slide 16 of 19 January 2006 STOP

 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 17 of 19 January 2006 STOP

 Quality Management

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

Module 2 | Slide 18 of 19 January 2006 STOP

 Quality Management
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

Module 2 | Slide 19 of 19 January 2006 STOP