药业公司天麻素注射液工艺验证方案.docx

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1、药业公司天麻素注射液工艺验证方案12020年4月19日文档仅供参考安徽宏业药业有限公司验证方案(初案)名称:天麻素注射液(2ml:0.2g)工艺验证方案部门职务签字日期验证方案起草人验证方案审核人验证方案批准人12020年4月19日文档仅供参考目录1.验证小组成员及职责···································32.产品概述·············································43.验证目的·············································4

2、4.验证范围·············································45.小容量注射剂车间天麻素注射液验证的培训··············46.验证时间和安排·······································57.工艺描述··············································58.验证前确认及准备································22020年4月19日文档仅供参考·····79.验证内容··············

3、·······························1210.生产线环境检测······································3511.成品检验············································4312.持续稳定性考察······································4413.再验证周期··········································4414.结果分析与评价···························

4、···········4415.验证结果············································4516.验证合格证32020年4月19日文档仅供参考书········································461.验证小组的成员及职责姓名部门资质职责42020年4月19日