Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Close this folderStability of drug dosage forms1
View the document1. Introduction
View the document2. General considerations
Open this folder and view contents3. Responsibility of parties involved in the assurance of drug stability
View the document4. Use of terms
View the document5. Less stable drug substances
View the documentReferences
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Open this folder and view contentsMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

References

1. WORLD HEALTH ORGANIZATION. The rational use of drugs. Report of the conference of experts, Nairobi. 25-29 November 1985. Geneva, 1987.

2. WHO Technical Report Series, No. 790, 1990 (Thirty-first report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations), Annex 5.

3. WHO Technical Report Series. No. 645,1980 (Twenty-seventh report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations), p. 27.

4. WHO Official Records, No. 226. 1975, Annex 12, Part 1.

5. WHO Technical Report Series, No. 567, 1975 (Twenty-fifth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations).

6. WORLD HEALTH ORGANIZATION. Basic tests for pharmaceutical substances. Geneva, 1986.

7. DÖRNER, G. ET AL. Management of drug purchasing, storage and distribution. Manual for developing countries, 2nd rev. ed. 1985 (available from Fédération internationale pharmaceutique (FIP), Alexanderstraat 11, 2514 JL The Hague; and from International Federation of Pharmaceutical Manufacturers Associations (IFPMA), 67 rue de St Jean, 1201 Geneva).

8. BATTERSBY, A. How to look after a health centre store. London, Appropriate Health Resources and Technologies Action Group, 1983.

9. Managing drug supply. Boston, MA, Management Sciences for Health, 1982.

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