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利巴韦林工艺验证.docx

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产品工艺验证利巴韦林注射液（1ml：100mg）

第1页共42页

长治市三宝生化药业有限公司编号SBB2.8.5.6

利巴韦林注射液生产工艺验证方案

长治市三宝生化药业有限公司

第2页共42页

方案制订

签名

日期

方案会签

签名

生产技术部签名

验证小组签名

日期

方案批准

质量保证部

日期

第3页共42页

1.概述`````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````4`1.1.产品简述``````````````````````````````````````````````````````````````````````````````````````````````````````````````41.2.处方及依据``````````````````````````````````````````````````````````````````````````````````````````````````````````4

1.3.生产工艺流``````````````````````````````````````````````````````````````````````````````````````````````````````````5`2.验证目的````````````````````````````````````````````````````````````````````````````````````````````````````````````````````53.验证的范围```````````````````````````````````````````````````````````````````````````````````````````````````````````````64.验证各部门职责及组织结构```````````````````````````````````````````````````````````````````````````````65.验证准备````````````````````````````````````````````````````````````````````````````````````````````````````````````````````76.验证内容及实施``````````````````````````````````````````````````````````````````````````````````````````````````````8`6.1.洗瓶工序````````````````````````````````````````````````````````````````````````````````````````````````````````````8

6.2.配制工序```````````````````````````````````````````````````````````````````````````````````````````````````````````126.3.灌封工序```````````````````````````````````````````````````````````````````````````````````````````````````````````156.4.灭菌工序```````````````````````````````````````````````````````````````````````````````````````````````````````````206.5.灯检工序``````````````````````````````````````````````````````````````````````````````````````````````````````