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...............................................................................................................

3、..........41.3目的Purpose................................................................................................................................41.4范围Scope........................................................................................................

4、............................52.责任RESPONSIBILITY................................................................................................73.方法APPROACH............................................................................................................83

5、.1工艺验证与验证批释放Processvalidationandreleaseofthevalidationbatch...................83.2Comparisontobiobatch.............................................................................................................83.3稳定性研究Stabilitystudytothisprocessvalidation.........

6、.....................................................83.4与工艺验证相关的清洁验证Cleaningvalidationrelatedtothisprocessvalidation............93.5分析方法与IPC/释放标准AnalyticalmethodoverviewincludingIPC/releasespecifications..............................................................

7、........................................................................................93.6结果记录与评估的方法Methodsforrecording&evalustingresults....................................94.工艺介绍PROCESS.............................................................................

8、........................114.1产品处方ProductFormulation.......................................................................................