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本册共收载了15个附录，其中包括多个重要的GMP规范，如新版的WHO GMP、血液制品GMP、无菌药品GMP、非无菌制剂HVAC等。制作有附录的书签，便于查看。
附录目录：
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 vi 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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发表于 2013-1-7 21:43:15
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