(第一部)
PIC/S:Guide to Good Manufacturing Practice for Medicinal Products
(Part I)
二氯丙醇
导针PE009-13 (1 January 2017) © PIC/S January 2017
第一部(Part I)
目錄
第一章製藥品質系統(PHARMACEUTICAL QUALITY SYSTEM) (3)
第二章組織與人事(PERSONNEL) (18)
干湿巾
第三章廠房設施與設備(PREMISES AND EQUIPMENT) (27) 第四章文件(DOCUMENTATION) (35)
第五章生產(PRODUCTION) (52)
第六章品質管制(QUALITY CONTROL) (65)
绝缘法兰第七章委外活動(OUTSOURCED ACTIVITIES) (80)
第八章申訴與產品回收(COMPLAINTS AND PRODUCT RECALL) (86) 气体膜分离第九章自我查核(SELF INSPECTION) (89)
第一章製藥品質系統(PHARMACEUTICAL QUALITY SYSTEM)