中国药物评价2023，Vol.40Issue(6)：537-540,4.
《PIC/S生物技术检查备忘录》分析与探讨
The Analysis and Discussion on"PIC/S Aide Memoire Inspection of Biotechnology Manufactures"
颜若曦1
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心,北京 100076
- 折叠
摘要
Abstract
The National Medical Products Administration applied for the pre-application of the Pharmaceutical Inspection Cooperation Program(PIC/S)in 2021.The PIC/S inspection aide memoires as key reference documentsforinspectors,the application of them are lis-ted as a PIC/S evaluation indicator content for the institution applying for accession.Based on the analysis of the historical revision,main framework,and major content of the PIC/S Aide Memoire Inspection of Biotechnology Manufactures,it summarizes the key inspection is-sues and main concerns from the perspective of the six major systems of drug manufacture.On the basis of experience in biological products inspection,it discusses the application and weakness of PIC/S Aide Memoire Inspection of Biotechnology Manufactures and provides refer-ence for inspectors to better understand the aide memoire and improve inspection practice.关键词
药品检查/生物制品/药品生产质量管理规范Key words
Drug inspection/Biological products/Good Manufacturing Practice(GMP)分类
医药卫生引用本文复制引用
颜若曦..《PIC/S生物技术检查备忘录》分析与探讨[J].中国药物评价,2023,40(6):537-540,4.
