Basic Principles of GMP

Quality
Management
Section 1 and 2

Module 2

Slide 1 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.

Module 2

To develop actions to resolve your current problems.

Slide 2 of 19

January 2006

Quality Management
Quality relationships
Quality Management

Quality Assurance

GMP

Production and Quality Control

Module 2

Slide 3 of 19

January 2006

Section 1 and 2

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 4 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 5 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 6 of 19

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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 7 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 8 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
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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
1.1 a- d
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Slide 10 of 19

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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

Module 2

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January 2006

1.1 e - h

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

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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 (selfinspection).
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 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.

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.
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Slide 14 of 19

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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

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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

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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

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Slide 17 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.
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Slide 18 of 19

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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, transport
Laboratories and in-process control
Module 2

Slide 19 of 19

January 2006

2.1 a - c

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
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Slide 20 of 19

January 2006

2.1 d - j

Quality Management

Group session I

How many GMP deficiencies can you find in the

photographs in the handout?

Module 2

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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 companys quality management programme
Describe the action to be taken in each case

Module 2

Slide 22 of 19

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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

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Slide 23 of 19

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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
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Slide 24 of 19

January 2006