Basic Principles of GMP

Quality Management

Part One

Module 2 Slide 1 of 26 WHO - EDM

 Quality Management
Objectives
 To understand key issues in quality
assurance/quality control.
 To understand specific requirements on
organization, procedures, processes and
resources.
 To develop actions to resolve your current
problems.

Module 2 Slide 2 of 26 WHO - EDM

 Quality Management
Quality Management
 Terminology may differ
 “Quality System” is said to be rarely used in drug
manufacturing
 The concepts of 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 Part One

Module 2 Slide 3 of 26 WHO - EDM

 Quality Management
Principles of Quality Assurance
 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
Part One 1.1
outside the scope of this module

Module 2 Slide 4 of 26 WHO - EDM

 Quality Management
Requirements for QA Systems – I
1. Ensure products are developed correctly
2. Identify managerial responsibilities
3. Provide SOPs for production and control
4. Organize supply and use of correct starting
materials
5. Define controls for all stages of manufacture and
packaging
Part One 1.2 a-j

Module 2 Slide 5 of 26 WHO - EDM

 Quality Management
Requirements for QA Systems – II
6. Ensure finished product correctly processed and
checked before release
7. Ensure products are released after review by
authorized person
8. Provide storage and distribution
9. Organize self-inspection

Part One 1.2 a-j

Module 2 Slide 6 of 26 WHO - EDM

 Quality Management
GMP
 Ensure that products are consistently produced
and controlled
 Diminishes risks that cannot be controlled by
testing of product
 Cross-contamination
 Mix-ups

Part One 2.1 a-j

Module 2 Slide 7 of 26 WHO - EDM

 Quality Management
Basic Requirements for GMP – I
1. Clearly defined and systematically reviewed
processes
2. Critical steps validated
3. Appropriate resources: personnel, buildings,
equipment, materials
4. Clearly written procedures
5. Trained operators
Part One 2.1 a-j

Module 2 Slide 8 of 26 WHO - EDM

 Quality Management
Basic Requirements for GMP – II
6. Complete records, failure investigations
7. Proper storage and distribution
8. Recall system
9. Complaint handling

Part One 2.1 a-j

Module 2 Slide 9 of 26 WHO - EDM

 Quality Management
Group session - I
 How many GMP deficiencies can you find in the
photographs in the handout?

Module 2 Slide 10 of 26 WHO - EDM

 Quality Management
Quality relationships

Quality Management

Quality Assurance

GMP

Part One 1, 2 and 3

Quality Control
Module 2 Slide 11 of 26 WHO - EDM
 Quality Management
Quality Control (QC)

 QC is part of GMP

Module 2 Slide 12 of 26 WHO - EDM

 Quality Management
Quality Control (QC) Department
 Each holder of a manufacturing authorization
should have a QC Department
 Independence from production and other
departments is considered to be fundamental
 Under the authority of an appropriately qualified
and experienced person with one or several
control laboratories at his or her disposal.
Part One 3.2

Module 2 Slide 13 of 26 WHO - EDM

 Quality Management
Basic Requirements for Quality Control

Resources
 Adequate facilities
 Trained personnel
 Approved procedures

Part One 3.2

Module 2 Slide 14 of 26 WHO - EDM

 Quality Management
Basic Requirements for Quality Control
Tasks
 Sampling
 Inspecting
 Testing
 Monitoring
 Releasing/rejecting
Part One 3.2

Module 2 Slide 15 of 26 WHO - EDM

 Quality Management
Basic Requirements for Quality Control - I
Objects
 Starting materials
 Packaging materials
 Intermediates
 Bulk products
 Finished products
 Environmental conditions Part One 3.2

Module 2 Slide 16 of 26 WHO - EDM

 Quality Management
Basic Requirements for Quality Control – II
1. Sampling approved by QC department
2. Validated test methods
3. Records
4. Review and evaluation of production
documentation
5. Failure investigations for all deviations
6. Ingredients comply with the marketing Part One 3.2 b – e
authorization

Module 2 Slide 17 of 26 WHO - EDM

 Quality Management
Basic Requirements for Quality Control – III
7. Ingredients are of the required purity
8. Proper containers
9. Correct labelling
10. Release of batches by the authorized person
11. Retained samples of starting materials and
products

Part One 3.2 e – h

Module 2 Slide 18 of 26 WHO - EDM

 Quality Management
Other Duties of the Quality Control
Department
1. Establish QC procedures
2. Reference standards
3. Correct labelling
4. Stability testing
5. Complaint investigations
6. Environmental monitoring
Part One 3.3

Module 2 Slide 19 of 26 WHO - EDM

 Quality Management
Assessment of Finished Products
Should embrace all relevant factors. For example:
 production conditions
 in-process test results
 manufacturing documentation
 compliance with finished product specification
 examination of the finished pack

Part One 3.4

Module 2 Slide 20 of 26 WHO - EDM

 Quality Management
QC Access
 QC Personnel MUST have access to production
areas for sampling and investigation
 As appropriate!

Part One 3.5

Module 2 Slide 21 of 26 WHO - EDM

 Quality Management
Quality Control - summary
 QC is part of GMP - refer to the handout
 authorization
 sampling  definition of product quality
 specifications  laboratory operations
 testing  release decisions
 release procedures  investigation and reporting
 recalls and complaints
 decision-making in all
quality matters
Part One 3.1, 3.2

Module 2 Slide 22 of 26 WHO - EDM

 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 impact on a company’s quality management
programme.
 Describe the action to be taken in each case

Module 2 Slide 23 of 26 WHO - EDM

 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 24 of 26 WHO - EDM

 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 25 of 26 WHO - EDM