文档介绍:欧洲药品生产质量管理规范目录第一章质量管理原则...........................................................................2质量保证.......................................................................2药品生产质量管理规范(GMP)......................................................2质量控制(QC)...................................................................3产品质量审核...................................................................3第二章人员原则...........................................................................4通则...........................................................................4关键人员.......................................................................4培训...........................................................................5人员卫生.......................................................................5第三章厂房和设备原则...........................................................................6通则...........................................................................6生产区.........................................................................6贮存区.........................................................................7质量控制区.....................................................................7辅助区.........................................................................7设备...........................................................................7第四章文件原则...........................................................................8通则...........................................................................8文件要求.......................................................................8第五章生产原则..........................................................................12通则..........................................................................12生产过程中交叉污染的预防......................................................12验证..........................................................................13原料..........................................................................13生产操作:中间产品和待包装产品.............................