纯蒸汽灭菌验证方案

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1、针剂车间CG-0.6型纯蒸汽灭菌柜再验证方案编定人审核人批准人药业有限公司目录1.概述··········································································································································32.再验证目的··················································································

2、········································33.引用标准·······························································································································34.验证组织职责························································································

3、·····························45.进度计划·······························································································································56.验证实施的步骤和要求·······························································································

4、56.1预确认···································································································································56.2运行确认·····························································································································

5、·56.3性能确认······························································································································57.异常情况处理程序·········································································································58.拟定验证周期···········

6、··········································································································69.结果与评定··························································································································61、概述针剂车间CG-0.6型纯蒸汽灭菌柜是一种全自动的灭菌器。选用

7、先进的微机可编程序控制器进行全程自动控制，密封门的开关锁紧实电动操作。是我公司注射剂车间的器具灭菌专用设备。该灭菌器于2004年安装，2005年通过GMP认证并于2010年通过了GMP再认证，现根据验证要求进行再验证。2、验证目的：2.1确认本设备能够正常运行符合安装要求，各项性能指标符合生产工艺要求。2.2提供必要的文件以证实本设备操作与所预期的完全一致。2.3确认本方案所制定的操作程序及验证方案,能有效地使本设备处于确认状态下,并能稳定地、恒常地达成其所预期的功能。3、引用标准：《药品生产质量管理规范》国家药品监督管理局2010年《

8、药品生产验证指南》国家食品药品监督管理局2003版《验证管理规程》《CG-0.6型纯蒸汽灭菌柜标准操作规程》《CG-0.6型纯蒸汽灭菌柜维护保养标准操作规程》4、验证组织职责4.1.验证领导小组：4.1.1