工艺验证草案--产品工艺验证-中美史克

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1、工艺验证草案ProcessValidationProtocolA片剂100mg制造工艺验证ProcessvalidationofVermox100mgTablets目录CONTENTTABLE目录CONTENTTABLE........................................................................................................................21.背景介绍INTRODUCTION.............................................

2、.............................................41.1验证产品基本信息BASICINFORMATIONOFVALIATIONEDPRODUCT..................41.2背景Background.........................................................................................................................41.3目的Purpose.................................

3、...............................................................................................41.4范围Scope....................................................................................................................................52.责任RESPONSIBILITY.....................................

4、...........................................................73.方法APPROACH............................................................................................................83.1工艺验证与验证批释放Processvalidationandreleaseofthevalidationbatch...................83.2Comparisontobiobatch..........

5、...................................................................................................83.3稳定性研究Stabilitystudytothisprocessvalidation..............................................................83.4与工艺验证相关的清洁验证Cleaningvalidationrelatedtothisprocessvalidation............93.5分析方法与IP

6、C/释放标准AnalyticalmethodoverviewincludingIPC/releasespecifications......................................................................................................................................................93.6结果记录与评估的方法Methodsforrecording&evalustingresults.............................

7、.......94.工艺介绍PROCESS.....................................................................................................114.1产品处方ProductFormulation.......................................................................................