验证生命周期

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1、验证生命周期ValidationLifeCycle13/04/2006RefreshGMPtrainingforEngineering目录Content验证介绍ValidationIntroduction验证生命周期Validationlifecycle总结SummaryGarfieldWangRefreshGMPtrainingforEngineering03/03/20102目的Objective•了解验证过程Haveacommandofthevalidationactivities•学习过去经验LearnfrompastGarfieldWangRefreshGMPtraini

2、ngforEngineering03/03/20103关于验证的一些说法SomeQuotes...•那些负责验证的人员需要回答很多问题：“验证为什么会延迟？”，”为什么会出现这个问题？”，“为什么要花多余的钱？”“Thoseresponsible...(forvalidation)...havemuchtoanswerforintermsofconfusion,delaysandunnecessarycost”.•验证在很多方面已成为我们工厂负面的强制性任务“Validationisbecoming,inmanyways,anegativeforcewithinoursite”.•

3、验证更多的是带有官僚色彩，而非科学化的操作过程“Itisevolvingintoabureaucraticexerciseratherthanascientificone”GarfieldWangRefreshGMPtrainingforEngineering03/03/20104验证需要ValidationWILLinvolve…•时间People’stime•资源Resources•生产过程/产品放行时间延迟Possibledelaysinproduction/productrelease•文件Documentation•准备SOPAvailableSOPsGarfieldWa

4、ngRefreshGMPtrainingforEngineering03/03/20105为什么NERI3的验证过程没有价值-一切正常WhynovaluefortheNERI3sensorvalidation?－everythingisOK但是But：市场上收到投诉ComplaintsreceivedfromthemarketQA中控－不稳定QAinprocesscontrol-unstable为什么会这样AskWHY??GarfieldWangRefreshGMPtrainingforEngineering03/03/20106那么为什么要验证SoWhyValidate?畅所欲言

5、BrainstormingGarfieldWangRefreshGMPtrainingforEngineering03/03/20107定义Definitions-EU•是一种证明符合GMP规范要求，任何的操作规范，工艺，设备，物料，行为或系统都能达到其预期的结果的操作Actionofproving,inaccordancewiththeprinciplesofGMP,thatanyprocedure,process,equipment,material,activityorsystemactuallyleadstotheexpectedresultsGarfieldWangRef

6、reshGMPtrainingforEngineering03/03/20108定义Definitions-WHO•是积累和评估数据的过程，从工艺开发到常规的生产过程，保证整个生产过程－包括设备，建筑，人员和物料能够一致的、连续性的达到其预期的结果Thecollectionandevaluationofdata,beginningattheprocessdevelopmentstageandcontinuingthroughtheproductionphase,whichensuresthatthemanufacturingprocesses-includingequipment,

7、buildings,personnelandmaterials-arecapableofachievingtheintendedresultsonaconsistentandcontinuousbasis.验证是通过文件证明所需验证的系统达到预期的标准Validationistheestablishmentofdocumentedevidencethatasystemdoeswhatitissupposedtodo.GarfieldWangRefreshGMPtrai