Committee for Human Medicinal Products (CHMP)Guideline on manufacture of the finished dosage form 制剂成品生产指南 This guideline replaces the “Note for Guidance on Manufacture of the Finishe d Dosag e Form”(CPMP/QWP/486/95)原创：2017-09-19 翻译组 GMP办公室 翻译：王世华 校对：Owen Execu...
This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are propos...
Committee for Human Medicinal Products (CHMP)Guideline on manufacture of the finished dosage form 制剂成品生产指南 This guideline replaces the “Note for Guidance on Manufacture of the Finishe d Dosag e Form”(CPMP/QWP/486/95)原创：2017-09-19 翻译组 GMP办公室 翻译：王世华 校对：Owen Execu...
ControlsofCriticalStepsandIntermediates关键步骤和中间产品的掌握Allcriticalstepsandintermediatesidentifiedduringthemanufactureofthefinishedproductshouldbelistedinthissectionincludinganyin-processcontrols,appliedtestmethodsandacceptancecriteria.全部的关键步骤和中间产品检验在本节中成品生产过程要确认,包括任何的过程掌握、应用...
Only product specific aspects of manufacture need to be described and included in the MA dossier; general elements of Good Manufacturing Practice (GMP), (ref. 3) should not be included. 只有生产的产品特性方面的描述需要包括在MA的文档中,常规的GMP的要素不需要包括进去。 4.1. Manufacturer(s) 生产...
ema制剂成品生产指南-2017(中英文)完整版.doc,EMA 制剂成品生产指南-2017 4 JJuly 2017 EMA/CHMP/QWP/245074/2015 Committee for Human Medicinal Products (CHMP) Guideline on manufacture of the finished dosage form 制剂成品生产指南 This guideline replaces the “N
Only product specific aspects of manufacture need to be described and included in the MA dossier; general elements of Good Manufacturing Practice (GMP), (ref. 3) should not be included. 只有生产的产品特性方面的描述需要包括在MA的文档中,常规的GMP的要素不需要包括进去。
DosageForm”8 (CPMP/QWP/486/95)9 Commentsshouldbeprovidedusingthistemplate.Thecompletedcommentsformshouldbesent toQWP@ema.europa.eu 10 KeywordsManufacture,drugproduct Guidelineonmanufactureofthefinisheddosageform EMA/CHMP/QWP/245074/2015Page2/13 Guidelineonmanufactureofthefinisheddosageform11 Tableof...
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+44-171) 418 84 00 Fax: (+44-171) 418 84 47EMEA/CVMP/126/95 FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE:MANUFACTURE OF THE FINISHED DOSAGE FORM FINAL APPROVAL BY THE CVMP DECEMBER 1995 DATE ...
CVMP/VICH/502/99杂质指南：残留溶剂 附录 Annex I: specifications for class 1 and class 2 residual solvents in active substances 附录I：活性物质中1类和2类残留溶剂质量标准 Annex II: residues of solvents used in the manufacture of finished products 附录II：制剂生产中使用的溶剂残留 Discussion at ...