QUALITY ASSURANCE OF

PHARMACEUTICAL PRODUCTS
PST 05207
 Introduction to Good
Manufacturing Practices
SESSION 01
 RELATIONSHIP BETWEEN QA, GMP AND QC.

QA-Quality assurance
QA
GMP-Good
manufacturing
practices GMP
QC-Quality Control

QC
 Learning Tasks
By the end of this session students are
expected to be able to:
• Give the overview of Good Manufacturing
Practice
• Define GMP
• List principles of Good Manufacturing Practice
• Explain the importance of Good
Manufacturing Practice in pharmaceutical
Manufacturing
Overview of Good Manufacturing Practice

• The first World health organization (WHO) drafts

text on good manufacturing practices (GMP) was
prepared in 1967 by a group of consultants at
the request of the Twentieth World Health
Assembly.
• In 1969, when the World Health Assembly
recommended the first version of the WHO
Certification Scheme on the Quality of
Pharmaceutical Products Moving in International
Commerce, it accepted at the same time the
GMP text as an integral part of the Scheme.
• The guide to GMP shall be used as a standard to
justify GMP status, which constitutes one of the
elements of the WHO Certification Scheme on the
Quality of Pharmaceutical Products Moving in
International Commerce, through the assessment
of applications for manufacturing authorizations
and as a basis for the inspection of manufacturing
facilities.
• It may also be used as training material for
government drug inspectors, as well as for
production, quality control and quality assurance
personnel in the industry.
 Definition of Good Manufacturing
Practices
Good Manufacturing Practices
• Good Manufacturing Practice is that part of
Quality Assurance which ensures that
pharmaceutical products are consistently
produced and controlled to the quality
standards appropriate to their intended use
and as required by the marketing
authorization or product specification.
 Principles of GMP
The following are the Principles of Good Manufacturing Practices: GMP is concerned
with both production and quality control. The basic principles /essential elements are:

• Quality assurance
• Good manufacturing practices • Premises
for pharmaceutical products
• Sanitation and hygiene • Equipment
• Qualification and validation • Materials
• Complaints and Product • Documentation
recalls
• Good practices in
• Contract production and
analysis
production
• Self-inspection and quality • Good practices in
audits quality control
• Personnel, Training and
Personal hygiene
 GENERAL GMP CONSIDERATIONS
• Manufacture of pharmaceutical products involve
operations of
purchase of materials production  quality
control release  storage  shipment of
finished products and the related controls.
• Such operations need to be carried out according to
Good Manufacturing Practices (GMP) that forms an
important part of a comprehensive system of
quality assurance.
• Adherence to GMP ensures that pharmaceutical
products are manufactured to meet quality
standards required for their intended use.
• Good manufacturing practice is that part of
quality assurance which ensures that products
are consistently produced and controlled to
the quality standards appropriate to their
intended use and as required by the marketing
authorization.
• GMP is aimed primarily at diminishing the
RISKS inherent in any pharmaceutical
production.
 RISKS IN PRODUCTION PROCESS
Such risks are essentially of two
types:
1. Cross-contamination (in particular
of unexpected contaminants) and
2. Mix-ups (confusion) caused by, for
example, false labels being put on
containers
 HOW TO MINIMIZE RISKS IN PRODUCTION PROCESS

1. All manufacturing processes are clearly defined,

systematically reviewed in the light of experience, and
shown to be capable of consistently manufacturing
pharmaceutical products of the required quality that comply
with their specifications;
2. Qualification and validation are performed.
3. All necessary resources are provided, including ,
– Appropriately qualified and trained personnel.
– Adequate premises and space.
– Suitable equipment and services.
– Appropriate materials, containers and labels
– Approved procedures and instructions.
– Suitable storage and transport.
1. Instructions and procedures are written in clear and
unambiguous language specifically applicable to the
facilities provided.
2. Operators are trained to carry out procedures correctly.
3. Records covering manufacture and distribution, which
enable the complete history of a batch to be traced, are
retained in a comprehensible and accessible form.
4. The proper storage and distribution of the products
minimizes any risk to their quality.
5. A system is available to recall any batch of product from
sale or supply.
6. Complaints about marketed products are examined; the
causes of quality defects investigated, and appropriate
measures taken in respect of the defective products to
prevent recurrence.
 IMPORTANCE OF GMP/WHY IS GMP IMPORTANT?

Poor quality medicines are not only a health

hazard, but a waste of money for both
governments and individual consumers.
Poor quality medicines can damage health
A poor quality medicine may contain toxic
substances that have been unintentionally
added.
A medicine that contains little or none of the
claimed ingredient will not have the intended
therapeutic effect.
GMP helps boost pharmaceutical export
opportunities:
Most countries will only accept import and sale of
medicines that have been manufactured to
internationally recognized GMP.
Governments seeking to promote their countries'
export of pharmaceuticals can do so by making
GMP mandatory for all pharmaceutical
production and by training their inspectors in GMP
requirement
END