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利巴韦林注射液生产工艺验证方案.doc

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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方案制订签名日期方案会签签名日期生产技术部签名日期验证小组签名日期方案批准质量保证部日期目录 1.概述`````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````4` 1.1.产品简述``````````````````````````````````````````````````````````````````````````````````````````````````````````````4 1.2.处方及依据``````````````````````````````````````````````````````````````````````````````````````````````````````````4 1.3.生产工艺流``````````````````````````````````````````````````````````````````````````````````````````````````````````5` 2.验证目的````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5 3.验证的范围```````````````````````````````````````````````````````````````````````````````````````````````````````````````6 4.验证各部门职责及组织结构```````````````````````````````````````````````````````````````````````````````6 5.验证准备````````````````````````````````````````````````````````````````````````````````````````````````````````````````````7 6.验证内容及实施``````````````````````````````````````````````````````````````````````````````````````````````````````8` 6.1.洗瓶工序````````````````````````````````````````````````````````````````````````````````````````````````````````````8 6.2.配制工序```````````````````````````````````````````````````````````````````````````````````````````````````````````12 6.3.灌封工序```````````````````````````````````````````````````````````````````````````````````````````````````````````15 6.4.灭菌工序```````````````````````````````````````````````````````````````````````````````````````````````````````````20 6.5.灯检工序````````````````````````````````````````````````````````````````````````````