关键词: font-size:medium, ">药品检查；生物制品；药品生产质量管理规范

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 listed 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 issues 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 reference for inspectors to better understand the aide memoire and improve inspection practice.

Key words: Drug inspection, Biological products, Good Manufacturing Practice（GMP）