工艺验证通用原则指南

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1、TheAlliancePharm(US),Inc.www.ephrma.com.cn美国洲际药业有限公司《美国FDA认证与申办指南》权威资讯系列《工艺验证的通用原则指南》GUIDELINEONGENERALPRINCIPLESOFPROCESSVALIDATION美国洲际药业有限公司网址：wwww.ephrma.com.cn电子邮件：ellen@AlliancePharmchina.com24Confidential&Proprietary美国FDA认证辅导权威资讯内部资料TheAlliancePharm(US),Inc.w

2、ww.ephrma.com.cn美国洲际药业有限公司GUIDELINEONGENERALPRINCIPLESOFPROCESSVALIDATION工艺验证的通用原则指南Preparedby:CenterforDrugEvaluationandResearch,CenterforBiologicsEvaluationandResearch,andCenterforDevicesandRadiologicalHealthFoodandDrugAdministrationMaintainedby:DivisionofManufac

3、turingandProductQuality(HFD-320)OfficeofComplianceCenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,Maryland20857ReprintedFebruary,1993byTheDivisionofFieldInvestigationsOfficeofRegionalOperationsOfficeofRegulatoryAffairsU.S.Foodand

4、DrugAdministration24Confidential&Proprietary美国FDA认证辅导权威资讯内部资料TheAlliancePharm(US),Inc.www.ephrma.com.cn美国洲际药业有限公司TABLEOFCONTENTS目录I.PURPOSE目的II.SCOPE范围III.INTRODUCTION简介IV.GENERALCONCEPTS通用概念V.CGMPREGULATIONSFORFINISHEDPHARMACEUTICALS关于最终药品的CGMP法规VI.GMPREGULATIONFO

5、RMEDICALDEVICES关于医疗器械的CGMP法规VII.PRELIMINARYCONSIDERATIONS预先考虑VIII.ELEMENTSOFPROCESSVALIDATION工艺验证的原理A.ProspectiveValidation预确认1.EquipmentandProcess设备和工艺a.Equipment:InstallationQualification设备：安装确认b.Process:PerformanceQualification工艺：性能确认c.Product:PerformanceQualifi

6、cation产品：性能确认2.SystemtoAssureTimelyRevalidation保证及时再验证的系统3.Documentation文件B.RetrospectiveProcessValidation回顾性工艺验证24Confidential&Proprietary美国FDA认证辅导权威资讯内部资料TheAlliancePharm(US),Inc.www.ephrma.com.cn美国洲际药业有限公司IX.ACCEPTABILITYOFPRODUCTTESTING产品检验的可接受性GuidelineonGener

7、alPrinciplesofProcessValidation工艺验证通用原则指南I.PURPOSE目的ThisguidelineoutlinesgeneralprinciplesthatFDAconsiderstobeacceptableelementsofprocessvalidationforthepreparationofhumanandanimaldrugproductsandmedicaldevices.本指南概要描述了FDA认为人用药、兽用药、医疗器械的工艺验证所必须遵循的一般原则。II.SCOPE范围24Co

8、nfidential&Proprietary美国FDA认证辅导权威资讯内部资料TheAlliancePharm(US),Inc.www.ephrma.com.cn美国洲际药业有限公司ThisguidelineisissuedunderSection10.90(21CFR10.90)andi