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
Open this folder and view contentsStability of drug dosage forms1
Close this folderGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
View the documentGeneral
View the documentDefinitions
View the document1. Stability testing
View the document2. Intended market
View the document3. Design of stability studies
View the document4. Analytical methods
View the document5. Stability report
View the document6. Shelf-life and recommended storage conditions
View the documentReferences
View the documentOfficial, international and national guidelines
View the documentAppendix 1. Survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs: answer sheet
View the documentAppendix 2. Stability testing: summary sheet
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

Official, international and national guidelines

Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.

Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. Richtlinie und Kommentar [Guidelines and commentary]. Pharmazeutische Industrie, 1985, 47(6):627-632.

European Community

Stability test on active ingredients and finished products. Note for guidance concerning the application of Part 1, Section F. Annex to Directive 75/318. In: The rules governing medicinal products in the European Community Vol. 1, the rules governing medicinal products for human use in the European Community (III/3574/92). Brussels, EEC Office for Official Publications of the European Community, 1991:50.

European Organization for Quality Control

Cartwright AC. The design of stability trials (memorandum and conclusions). London, European Organization for Quality Control, Section for Pharmaceutical and Cosmetic Industries, 1986.

Food and Drug Administration, USA

Guidelines for stability studies for human drugs and biologics. Rockville, MD, Center for Drugs and Biologics, Office of Drug Standards, Food and Drug Administration, 1987.

Expiration dating and stability testing for human drug products. Inspection technical guide. Rockville, MD, Food and Drug Administration, 1985, No. 41.

Former German Democratic Republic

Testing of medicaments. International digest of health legislation, 1987, 38(2):309-316. (For original reference, see: First regulations of 1 December 1986 for the implementation of the Medicaments Law. Testing, authorization, and labelling of medicaments intended for use in human medicine. Gesetzblatt der Deutschen Demokratischen Republik, Part 1, 10 December 1986, 37:479-483.)

Pharmacopoeia of the German Democratic Republic, English version. Berlin, 1988:99 (AB DDR 85).

International Conference on Harmonisation

Stability testing of new drug substances and products. Harmonised tripartite guideline. 1993 (available from ICH Secretariat, c/o IFPMA, 30 rue de St-Jean, 1211 Geneva, Switzerland).


Draft policy to deal with stability data required in applying for approval to manufacture (import) drugs and draft guidelines for stability studies. Tokyo, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 1990.

Pharmaceutical Inspection Convention

Stability of pharmaceutical products: collected papers given at a seminar, Salzburg, 9-11 June 1976 (available from the Secretariat to the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products, c/o EFTA Secretariat, 9-11 rue de Varembé, 1202 Geneva, Switzerland).

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