第1页共48页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共48页优良的生产实践(GMP)...................................................................................................................1一．GMP历史.........................................................................................................................1二、GMP分类.........................................................................................................................3三、GMP三大目标要素.........................................................................................................4四、GMP的基本原则.............................................................................................................5药品生产质量管理规范（1998年修订）......................................................................................6第一章总则..........................................................................................................................6第二章机构与人员................................................................................................................6第三章厂房与设施................................................................................................................7第四章设备............................................................................................................................8第五章物料............................................................................................................................9第六章卫生......................................................................................................................10第七章验证........................................................................................................................10第八章文件.......................................................................................................................11第九章生产管理..................................................................................................................12第十章质量管理..................................................................................................................12第十一章产品销售与收回...................................................................................................13第十二章投诉与不良反应报告...........................................................................................13第十三章自检..................................................................................................................14第十四章附则..................................................................................................................14药品生产质量管理规范附录.................................................................................................14一、总则..............................................................................................................................14二、无菌药品........................................................................................................................16三、非无菌药品....................................................................................................................17四、原料药............................................................................................................................17...
