注射用三磷酸腺苷二钠氯化镁工艺验证方案审核和批准目录1、概述..................................................................................................................................................................41.1产品简介..........................................................................................................................................................41.2验证原因..........................................................................................................................................................41.3验证类型..........................................................................................................................................................41.4验证范围..........................................................................................................................................................41.5计划验证时间..................................................................................................................................................42、验证依据..........................................................................................................................................................43、验证人员及职责...............................................................................................................................................54、验证条件..........................................................................................................................................................65、生产工艺与设备...............................................................................................................................................75.1生产工艺处方...................................................................................................................................................75.2生产工艺流程图..............................................................................................................................................95.3生产操作过程及工艺条件.............................................................................................................................105.4主要设备一览表............................................................................................................................................135.5产品质量标准................................................................................................................................................156、工艺验证过程.................................................................................................................................................166.1配液工序........................................................................................................................................................176.2灌装工序........................................................................................................................................................226.3冻干工序........................................................................................................................................................257、成品检验情况.................................................................................................................................................278、稳定性考察...
