美国fda验证高级培训--验证2011.4

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1、美国FDA验证高级培训1目录TableOfContents1.验证定义2.CGMP对验证的要求3.验证历史与期望4.验证综述5.验证主方案与规划6.实施验证的方法7.验证的技术内容要求8.执行验证方案9.工作流程10.改变控制11.再验证12.总结PartOne:WhatisValidation?第一部分：验证定义3WhatisValidation?验证的含义？•ForthisSeminaritreferstotwothings:•1.TheUSAFDArequirementsthatmustbemetinordertosuccessfullyandc

2、ontinuallyselldrugproductsintheUSA•2.Activitiesthatwillcontributetothesuccessofthecompanyinthemanufactureofdrugproducts4Validation业内对验证的理解“Anythingwhichyoucannotunderstandisindistinguishablefrommagic.”•ArthurC.Clark“Validationmaynotbemagic!”•C.Edwards5ValidationIs.....FDA对验证的定义“

3、Documentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes.”6WhyDoWeValidate?验证的作用/目的ToConsistentlyProduceProductComplianceADesiredKnownProductConfirmDesignTestwithinSpecificat

4、ionEstablishOperatingBoundariesEstablishBaselines7DetailsWillHowDoWeValidate?FollowButThisistheGeneral验证流程图ModelIdentifyEquipmentAmendDevelopTestsSystemsTestConductTestsAmendWriteProtocolsProtocolCollectDataEvaluateDataResultsOK?NoReportResultsyesValidatedSystem现代中药制药论坛www.tcme.

5、cn（尚未开通）SystemModified?QQ群：1507458378FirstthreestepstoCGMPcompliance符合CGMP要求的头三步•document•document•document（尚未开通）9BoundariesofValidation验证的界限/范围DOCUMENTEDCOMMISSIONINGPROGRAMSTANDARDOPERATINGSTART-UPHIGHDEGREEOFPROCEDURESASSURANCETROUBLESHOOTINGMFGBATCHRECORDSCONSISTENTLYPERSONN

6、ELTRAININGTRIALRUNSMEETSCALIBRATIONPREDETERMINEDCYCLEDEVELOPMENTPREVENTATIVEMTCESPECIFICATIONSPROCESSDEVELOPMENTCHANGECONTROLENGINEERINGSTUDIESCOMPLIANCEVENDORAUDITSVENDORSERVICEREPORTSANNUALREVIEWSFACTORYACCEPTANCETESTCOMPLAINTS“AS-BUILT”DRAWINGSSAFETY10ValidationLifeCycleAppro

7、achNew/RevisedProcess/ProductProspective/ConcurrentDefineSpecifications验证生命周期:EquipmentProcessRequirements新的/修改过的工艺/产品ProceduresDesign/SpecifyDefineProcessEquipmentDevelopProcedureInstallSpec.EquipmentDataVerifyProcedureQualifyOneLotSpecificationsEquipmentConcurrentValidationRep

8、ortDevelopValidationProtocolAcceptanceObtainDat