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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 概述··········································································································································3 再验证目的··························································································································3 引用标准·······························································································································3 验证组织职责·····················································································································3 进度计划·······························································································································5 验证实施的步骤和要求·······························································································5 6.1 预确认···································································································································5 6.2 运行确认······························································································································5 6.3 性能确认······························································································································6 7. 异常情况处理程序·········································································································8 8. 拟定验证周期·····················································································································8 9. 结果与评定··························································································································9 1、概述 针剂车间SZA920/75杀菌干燥机是一种干热灭菌设备，是我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。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, 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 《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
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