2010版新版GMP规范附录.pdf

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1、《药品生产质量管理规范（2010修订）》附录2011-02-25目录无菌药品.........................................................3第一章范围....................................................3第二章原则....................................................3第三章洁净度级别及监测................................

2、........3第四章隔离操作技术............................................7第五章吹灌封技术..............................................8第六章人员....................................................8第七章厂房....................................................9第八章设备................

3、...................................11第九章消毒...................................................11第十章生产管理...............................................12第十一章灭菌工艺.............................................14第十二章灭菌方法.........................................

4、....15第十三章无菌药品的最终处理...................................18第十四章质量控制.............................................18第十五章术语.................................................19第八十一条下列术语含义是：....................................19原料药.................................

5、......................20第一章范围....................................................20第二章厂房与设施..............................................20第三章设备....................................................20第四章物料...................................................2

6、1第五章验证....................................................22第六章文件....................................................24第七章生产管理................................................25第八章不合格中间产品或原料药的处理............................28第九章质量管理.........................

7、.......................29第十章采用传统发酵工艺生产原料药的特殊要求....................30第十一章术语..................................................321生物制品..........................................................34第一章范围...................................................34第二章原则.

8、..................................................34第三章人员...................................................35第四章厂房与设备.............................................35第五章动物房及相关事项.......................................