(1997; 248 pages) [French]
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.
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).