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发表于 2013-5-21 20:38:58
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这个已经过时了。
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 961 - Forty-fifth Report (Geneva, 18–22 October 2010)
(2011; 440 pages)
Abstract
Annex 1: Release procedure of International Chemical Reference Substances;
Annex 2: WHO good practices for pharmaceutical microbiology laboratories;
Annex 3: WHO good manufacturing practices: main principles for pharmaceutical Products;
Annex 4: WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization);
Annex 5: WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms;
Annex 6: WHO good manufacturing practices for sterile pharmaceutical products;
Annex 7: WHO guidelines on transfer of technology in pharmaceutical manufacturing;
Annex 8: Good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO);
Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization);
Annex 10: Procedure for prequalification of pharmaceutical products;
Annex 11: Guidelines on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities;
Annex 12: Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies;
Annex 13: WHO guidelines for preparing a laboratory information file;
Annex 14: WHO guidelines for drafting a site master file;
Annex 15: Guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format
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