Basic Principles of GMP
Quality Management
Section 1 and 2
Module 2
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Slide 1 of 19
January 2006
Quality Management
Objectives
Module 2
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To understand key issues in quality assurance/good manufacturing
practices/quality control.
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To understand specific requirements on quality management and
quality assurance including:
 Organization
 Procedures, processes and resources.

To develop actions to resolve your current problems.
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Slide 2 of 19
January 2006
Quality Management
Quality relationships
Quality Management
Quality Assurance
GMP
Section 1 and 2
Production and Quality Control
Module 2
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Slide 3 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
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Slide 4 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
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Slide 5 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
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Slide 6 of 19
January 2006
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
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Slide 7 of 19
January 2006
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
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Slide 8 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
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Slide 9 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
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Regular evaluation of product quality to verify consistency and
continued improvement
1.1 i - l
Module 2
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Slide 10 of 19
January 2006
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
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Slide 11 of 19
January 2006
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
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Slide 12 of 19
January 2006
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
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Slide 13 of 19
January 2006
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
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Slide 14 of 19
January 2006
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
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Slide 15 of 19
January 2006
Quality Management
Group session – I
 How many GMP deficiencies can you find in the
photographs in the handout?
Module 2
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Slide 16 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
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Slide 17 of 19
January 2006
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
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Slide 18 of 19
January 2006
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
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Slide 19 of 19
January 2006