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
Determines and implements the quality policy
The basic elements are:
an appropriate infrastructure or quality system
encompassing the 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
Part One

Module 2 Slide 3 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 4 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
Part One 1.1
and also product design and development
which is outside the scope of this module
Module 2 Slide 5 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 6 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 7 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 8 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 9 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 10 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 11 of 26 WHO - EDM

 Quality Management
Quality relationships

Quality Management

Quality Assurance

GMP

Part One 1, 2 and 3

Quality Control
Module 2 Slide 12 of 26 WHO - EDM
 Quality Management
Quality Control (QC)

QC is part of GMP

Module 2 Slide 13 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 14 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 15 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 16 of 26 WHO - EDM

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

Module 2 Slide 17 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 18 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 19 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 20 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 21 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 22 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 23 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 companys quality
management programme.
Describe the action to be taken in each
case

Module 2 Slide 24 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 25 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 26 of 26 WHO - EDM