Sinomach Pharma Industry Validation-chinese and en

©SinomachTrainingModule4PharmaceuticalIndustryValidation制药工业的验证Presentedby-JonathanWoodburn,VicePresident,Compliance&Validation©SinomachTrainingModule4GoodManufacturingPractice(GMP)良好生产规范(GMP)Goodmanufacturingpracticeisthatpartofqualityassurancewhichensuresthatproductsareconsistentlyproducedandcontrolledtothequalitystandardsappropriatetotheirintendeduseandasrequiredbythemarketingauthorisation.GMP是质量保证的一部分，它保证产品按照其使用要求及管理部门规范，以适当的质量标准持续稳定地生产。©SinomachTrainingModule4TenCommandmentsofGMPGMP十诫IThoushaltwritethyprocedures!你必须编写规程IIThoushaltfollowthywrittenprocedures!你必须按照规程操作IIIThoushaltdocument(record)thywork!你必须将工作记录存档IVThoushaltvalidatethywork!你必须验证有关工作VThoushaltdesignandbuildproperfacilitiesandequipment!你必须设计建造正确的厂房和设备VIThoushaltmaintainthyfacilitiesandequipment!你必须维护好厂房和设备VIIThoushaltbecompetent(asaresultofeducation,trainingandexperience)!你必须胜任工作（源自教育，训练和经验积累）VIIIThoushaltbeclean!你必须洁净IXThoushaltcontrolforquality!你必须控制质量XThoushaltauditforcompliance!你必须考核审计GMP符合情况©SinomachTrainingModule4Definition-PharmaceuticalProcessValidation定义-制药工艺验证FDAValidationisestablishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspre-determinedspecificationsandqualityattributes.验证是指通过提供文件记录证明，切实保证某一特定工艺持续生产出符合其预定规格及质量特性的产品。©SinomachTrainingModule4Definition-PharmaceuticalProcessValidation定义-验证Simplystated,Validationisproofthat……..简而言之，验证将证明AProcessWorks!某一过程可正常进行©SinomachTrainingModule4ProcessValidation-WhyValidate?为何验证？TheneedforValidation验证的必要性Regulatoryrequirement(cGMP)规范的要求(cGMP)Improvedproductquality改进产品质量AQualityAssuranceapproach质量保证体系的环节Efficientmanufacturingprocesses确认生产过程有效性Goodbusinesspractice良好的行业规范©SinomachTrainingModule4ProcessValidation-WhyValidate?为何验证？15%ofproductioncostiswaste.有15%的产品为废品Lossesinmanufacturingprocessareunavoidable??生产过程中的损失是不可避免的Wasteiscreatedbecausepotentialsourcesoftroubleareunknown.因潜在问题原因不明，废品因而产生Adequatevalidationpreventsunpleasantandexpensivesurprisesarisingfromtheprocess.恰当的验证可避免过程中不愉快及昂贵的意外产生©SinomachTrainingModule4ProcessValidation-WhyValidate?为何验证？ValidationandcGMPs验证与cGMPProcessvalidationisrequired,inbothgeneralandspecificterms,bytheCurrentGoodManufacturingPracticeRegulationsforFinishedPharmaceuticals,21CFRParts210and211根据有关制剂的现行GMP规范及21CFR第210和211部分的要求，过程验证在原则上和具体实践中都是必须的WHOGoodmanufacturingpracticesforpharmaceuticalproductsdefinevalidationandprovidedetailsofprocessvalidation世界卫生组织的GMP对验证提出了明确定义及详细规定©SinomachTrainingModule4OrganisingforValidation组织验证PreliminaryConsiderations基本考虑Whendesigningandundertakingaprocessvalidationstudyallfactorsaffectingproductqualitymustbeconsidered在设计和实施验证时所有影响产品质量的因素都要考虑到Suchfactorsmayvaryamongstdifferentproductsandmanufacturingtechnologies根据产品及生产工艺不同这些因素有所不同Nosingleapproachtoprocessvalidationwillbeappropriateandcompleteinallcases没有一种途径能够应用于所有情形©SinomachTrainingModule4OrganisingforValidation组织验证PreliminaryConsiderations基本考虑Acceptablemeasurablerangesmustbespecifiedforeachproductcharacteristicthatimpactsontheperformance,reliabilityandstabilityoftheproduct影响产品性能，可靠性和稳定性的合格技术指标须明确Thevalidityofacceptancespecificationsshouldbeverifiedthroughtestingandchallengeoftheproductonasoundscientificbasisduringtheinitialdevelopmentandproductionphase技术指标的正确性须经实验测试Onceaspecificationisset,anychangestothemmustbemadeinaccordancewithdocumentedchangecontrol当规格确立后，任何更改必须符合文件管理控制要求©SinomachTrainingModule4APPROACHTOCOMMISSIONING&VALIDATION调试及验证的安排VALIDATIONOVERVIEWInstallation安装确认Equipment&Facilities设备和设施Construction&Installation施工和安装Design设计OperationalQualificationFunctionalTestingwithWaterLinksEquipmenttoMethodologyDemonstrationIntroductionofChemicalsLinksEquip/MethodwithMaterialsPerformanceQualificationMinimumofThreeConsecutiveBatchesValidatedRoutineManufacture©SinomachTrainingModule4OrganisingforValidation验证的组织ValidationSequence验证的顺序Splitoperationintologicalunits将整个过程分为各个单元Definetheparametersandacceptancecriteriaforeachunit将每个单元的参数和验收标准进行明确Defineandapprovethequalificationtests定义并批准确认测试Conductandrecordresults记录测试结果Reviewdataforeachunitandfortotaloperation对每一单元及整体做出考核评价Prepareandapprovethefinalreport准备并批准最终报告PLAN1UNIT2n1TESTS2n1RESULTS2n1REVIEW2nREPORT©SinomachTrainingModule4OrganisingforValidation验证的组织ValidationSequence验证的顺序ValidationMasterPlan验证大纲DetailedOverviewPlansandRationales详细的总体计划和理论依据QualificationProtocols验证方案TestResults测试结果DetailedSummaryReportsorReviewsofResults详细的报告总结或结果的评估FinalValidationReport最终验证报告PLAN1UNIT2n1TESTS2n1RESULTS2n1REVIEW2nREPORT©SinomachTrainingModule4OrganisingforValidation验证的组织VALIDATIONMASTERPLANVALIDATIONSUMMARYREPORTDQIQOQPQDQIQOQPQPROTOCOLSREPORTSDQIQOQPQDQIQOQPQPROTOCOLSREPORTSDQIQOQPQDQIQOQPQPROTOCOLSREPORTSTESTING©SinomachTrainingModule4OrganisingforValidation验证的组织ValidationDocumentation验证文件Ifitisnotdocumented...........如果不能记录存档...........Itisarumour!就是假的!©SinomachTrainingModule4OrganisingforValidation验证的组织ValidationTeam验证团队Customer业主ProjectManager项目经理QualityAssurance质量保证ValidationManager验证经理EngineeringSupport设计支持TechnicalSup