隧道烘箱验证方案2012.doc

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1、针剂车间SZA920/75型杀菌干燥机再验证方案编定人审核人批准人XXXX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、·································35.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······························································································································67.异常情况处理程序·········································································································88.拟定验证周期··········

6、···········································································································89.结果与评定··························································································································91、概述针剂车间SZA920/75杀菌干燥机是一种干热灭菌设备，是我

7、公司注射剂车间的瓶子灭菌专用设备。瓶子随输送带的输送依次进入隧道灭菌烘箱的预热区、高温灭菌区和低温冷却区，整个过程始终处于百级层流保护之下。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

8、监督管理局2010年《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》《SZA920/75杀菌干燥机标准操作规程》《SZA920/75杀菌干燥机维护保养标准操作规程》4、验证