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GMPs for Pharmaceutical Products - Main Principles

GMPs for Pharmaceutical Products - Main Principles

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Published by: melfer on Jul 19, 2009
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36
© World Health OrganizationWHO Technical Report Series, No. 908, 2003
Annex 4
Good Manufacturing Practices for pharmaceuticalproducts: main principles
Introduction
37
General considerations
39
Glossary
39
Quality management in the drug industry: philosophy and essentialelements
45
1.
Quality assurance
45
2.
Good manufacturing practices for pharmaceutical products (GMP)
47
3.
Sanitation and hygiene
48
4.
Quali
fication and validation
48
5.
Complaints
49
6.
Product recalls
50
7.
Contract production and analysis
51General51The contract giver51The contract accepter52The contract52
8.
Self-inspection and quality audits
53Items for self-inspection53Self-inspection team54Frequency of self-inspection54Self-inspection report54Follow-up action54Quality audit54Suppliers
audits and approval54
9.
Personnel
55General55Key personnel55
10.
Training
59
11.
Personal hygiene
59
12.
Premises
60General60Ancillary areas61
 
37
Storage areas61Weighing areas62Production areas62Quality control areas64
13.
Equipment
64
14.
Materials
65General65Starting materials66Packaging materials67Intermediate and bulk products68Finished products68Rejected, recovered, reprocessed and reworked materials68Recalled products68Returned goods69Reagents and culture media69Reference standards69Waste materials70Miscellaneous70
15.
Documentation
70General71Documents required72
16.
Good practices in production
79General80Prevention of cross-contamination and bacterial contaminationduring production80Processing operations81Packaging operations82
17.
Good practices in quality control
84Control of starting materials and intermediate, bulk and
nishedproducts85Test requirements86Batch record review87Stability studies88
References
88
Introduction
The
rst WHO draft text on good manufacturing practices (GMP)was prepared in 1967 by a group of consultants at the request of theTwentieth World Health Assembly (resolution WHA20.34). It wassubsequently submitted to the Twenty-
rst World Health Assemblyunder the title
Draft requirements for good manufacturing practicein the manufacture and quality control of drugs and pharmaceuticalspecialities
and was accepted.The revised text was discussed by the WHO Expert Committee onSpeci
cations for Pharmaceutical Preparations in 1968 and published
 
38
as an annex to its twenty-second report. The text was then reproduced(with some revisions) in 1971 in the Supplement to the second editionof 
The International Pharmacopoeia
.In 1969, when the World Health Assembly recommended the
rstversion of the WHO Certi
cation Scheme on the Quality of Pharma-ceutical Products Moving in International Commerce in resolutionWHA22.50, it accepted at the same time the GMP text as an integralpart of the Scheme. Revised versions of both the Certi
cation Schemeand the GMP text were adopted in 1975 by resolution WHA28.65.Since then, the Certi
cation Scheme has been extended to include thecerti
cation of:
veterinary products administered to food-producing animals;
starting materials for use in dosage forms, when they are subject tocontrol by legislation in both the exporting Member State and theimporting Member State;
information on safety and ef 
cacy (resolution WHA41.18, 1988).In 1992, the revised draft requirements for GMP were presented inthree parts, of which only Parts One and Two are reproduced in thisdocument (
1
).
Quality management in the drug industry: philosophy and essentialelements
, outlines the general concepts of quality assurance as wellas the principal components or subsystems of GMP, which are jointresponsibilities of top management and of production and qualitycontrol management. These include hygiene, validation, self-inspec-tion, personnel, premises, equipment, materials and documentation.
Good practices in production and quality control
, provides guid-ance on actions to be taken separately by production and by qualitycontrol personnel for the implementation of the general principles of quality assurance.These two parts were subsequently supplemented by further guide-lines which are integral parts of these good manufacturing practicesfor pharmaceutical products. All these texts are available on theweb page of the World Health Organization. (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html)Considerable developments in GMP have taken place in the interven-ing years, and important national and international documents, in-cluding new revisions, have appeared (
 2
,
 3
,
4
,
 5
). Thus the necessity torevise the main principles and incorporate the concept of validation.

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