Setting specifications for drug substances and drug products

Drugs Made in Germany

Volumn 39, Issue 2, 1996, Pages 45-50

  Blume, Henning H ^a   Cartwright, Anthony C ^b   Möller, Helga ^c  

^a ABDA Bundesvereinigung Deutscher Apothekerverbande   (Germany)

^b Medicinal Control Agency   (United Kingdom)

^c SANOFI   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; DRUG ANALYSIS; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG PURITY; GOOD MANUFACTURING PRACTICE; QUALITY CONTROL; SYMPOSIUM;

EID: 0029938289     PISSN: 00126683     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (8)

1. Möller, H., Kirrstetter, R., Worm, M., Pharm. Ind. 56, 780 (1994)
2. European Pharmacopoeia Commission. Memorandum to the licensing authorities. PA/PH/SG (94) 109, July 1994
3. ICH Guidelines "Impurities in New Drug Substances" (Final) (1995)
4. ICH Guidelines "Impurities in New Drug Products" (Step 2) (1995)
5. EC-Guideline for "Specifications and Control Test on the Finished Product" (1993)
6. FIP Guidelines for "Dissolution Testing of Solid Oral Products" (Draft) Pharm. Ind. 57, 362 (1995)
7. USP 23, United States Pharmacopeial Convention, Inc. (1995)
8. EC-Guideline for "Quality of prolonged release oral solid dosage forms" (1991)