WHO GMP for pharmaceutical products: main principles WHO 药品 GMP: 总则 Dr Estevão Cordeiro and Dr Van Zyl updated ECSPP members on progress in revising theWHO good manufacturing practices for pharmaceutical products: main principles(11). The existing guideline described the main principles of qua...
GOOD MANUFACTURING PRACTICES (GMP) FOR PHARMACEUTICAL EXCIPIENTS 热度: 1 GoodManufacturingPracticeforPharmaceuticalProducts(GMP) 药品生产质量管理规范药品生产质量管理规范药品生产质量管理规范药品生产质量管理规范 (Amendedin1998)SDAOrder#9(1998年修订) Chapter1:GeneralProvisions总则总则总则总则 ...
1969年第22届世界卫生大会WHO建议各成员国的药品生产采用GMP制度,以确保药品质量和参加“国际贸易药品质量签证体制” (Certificate-ion Scheme On the Quality Of Pharmaceutical Products Moving in International Commerce,简称签证体制)。
[1] Immel B K. A brief history of the GMPs for pharmaceuticals[J]. Pharmaceutical technology, 2001, 25(7): 44-53. [2]https://www.theatlantic.com/technology/archive/2018/01/the-accidental-poison-that-founded-the-...
Manufacturing Practices for pharmaceutical products: main principles (WHO TRS 908, 2003). Recently WHO TRS 961 has published the updated contents on GMP in Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products (WHO TRS 961, 2011). 2. Importance of GMP In...
No. The CGMP regulations neither approve nor prohibit specific equipment for use in manufacturing of pharmaceutical products (with the exception of asbestos and fiber-releasing filters, see 21 CFR 211.72).? We do not maintain a list of appr...
filled in areas used for the processing of other pharmaceutical products; however, vaccines consisting of dead organisms or of bacterial extracts may be dispensed into containers, after validated inactivation and validated cleaning procedures, in the same premises as other sterile pharmaceutical products....
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Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philosophy and essential elements 制药企业的质量管理:GMP 理念和基本元素 1. Pharmaceutical quality...
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