工艺验证草案--产品工艺验证-中美史克

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..........................................................................................41.1验证产品基本信息BASICINFORMATIONOFVALIATIONEDPRODUCT..................41.2背景Background.........................................................................................................................41.3目的Purpose................................................................................................................................41.4范围Scope....................................................................................................................................52.责任RESPONSIBILITY................................................................................................73.方法APPROACH............................................................................................................83.1工艺验证与验证批释放Processvalidationandreleaseofthevalidationbatch...................83.2Comparisontobiobatch.............................................................................................................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IPC/释放标准AnalyticalmethodoverviewincludingIPC/releasespecifications......................................................................................................................................................93.6结果记录与评估的方法Methodsforrecording&evalustingresults....................................94.工艺介绍PROCESS.....................................................................................................114.1产品处方ProductFormulation...............................................................................................114.1.1处方Formulation............................................................................................................114.1.2原材料合格供户清单QualifiedsuppliersListofrawmaterials.................................124.2接触容器Immediatecontainers...............................................................................................134.3生产设备和设施ManufacturingEquipmentandFacility....................................................134.4工艺流程图ProcessFlowDiagram.........................................................................................144.5关键工艺参数与变量CriticalProcessParametersandVariables.......................................155工艺验证过程PROCESSVALIDATION...........................................................................165.1粘合液制备Preparebindingsolution.....................................................................................165.2干混工序Dry-mixing(Pre-mixing).........................................................................................185.3湿法制粒和干燥工序WetGranulationandDrying..............................................................205.4整粒工序Breaking....................................................................................................................235.5不加硬脂酸镁的混合MixingwithoutMagnesiumstearate..................................................245.6加硬脂酸镁的混合MixingwithMagnesiumstearate............................................................265.7中间体桶料Indrums................................................................................................................305.8压片工序Thetabletingprocess...............................................................................................325.9贮存时间Holdingtimestudy...................................................................................................366验证中偏差/变更处理DEVIATIONANDCHANGEHANDLING.......................................387培训TRAINING...............................................................................................................388参考文献REFERENCE........................................................................错误!未定义书签。1.背景介绍INTRODUCTION1.1BASICINFORMATIONOFVALIATIONEDPRODUCT产品名称PRODUCTNAME:A片剂VermoxTablets物料编码MATERIALCODE:剂量STRENGTH:亚批次SUB-BATCHES标示重量NORMALWEIGHT批量BATCHSIZE:批记录编号BPRCODE变更控制编号CCN:本次验证工艺步骤PRODUCTIONSTEP:制粒/整粒/混合/压片Granulating/Breaking/Mixing/Compressing1.2Background生产的A100mg口服片剂的主要成分是BBBB，自1988年投放到生产后，先后进行了三次工艺验证，详细情况参见下表。次数No时间Time报告号Reportcode验证内容Content结果Results1合格Pass2合格Pass3合格Pass自2001年验证完成后，A的生产工艺和生产设备均没有发生变更，未出现与工艺相关的不符合事件。依据中国cGMP第七章/第58条、工艺验证管理程序SMP-VMP006有关周期性再验证的规定，在2001年成功实施工艺验证后在2006年需要对A100mg口服片剂的制造工艺再次进行全面的验证，确保现行的工艺流程可以继续稳定、持续的生产出合格的产品。1.3Purpose该方案的目的是Thepurposeofthisprotocolisto:确认所需验证的工艺能够有效并重复地生产出符合所有事先确定的质量标准与品质的中间产品，并且如果适用的话，确认在制造完成后至包装开始前的预先设定的中间品保留时间能够始终一致地保证中间产品的质量特性。提出一个工艺验证方案。该方案确定在实际操作条件下需要监控的关键工艺参数和变量，概括对中间品样品的取样与检测的要求，并规定工艺监控及产品检测的接受标准。更具体而言，本次工艺再验证工作的目的是用书面证据来证明当运行操作正确时，A100mg口服片剂的生产工艺过程能够始终一致地生产出符合已确定的接受标准的产品。1.4Scope本验证草案适用于A100mg片的制造工艺再验证，依据本次验证的目的，在本次验证中将要研究的工艺步骤