FDA无菌生产指南-中英文对照版

CopyrightSCIVersion1Translatedfrom/译自：GuidanceforIndustrySterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingPractice行业指南无菌加工生产的无菌药品—现行的生产质量管理规范(cGMP）U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)OfficeofRegulatoryAffairs(ORA)September2004PharmaceuticalCGMPsCopyrightSCIVersion1GuidanceforIndustrySterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingPracticeAdditionalcopiesareavailablefrom:OfficeofTrainingandCommunicationDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573://(Tel)VoiceInformationSystemat800-835-4709or301-827-1800U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)OfficeofRegulatoryaffairs(ORA)September2004PharmaceuticalCGMPsContainsNonbindingRecommendationsCopyrightSCIVersion1TABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1简介II.BACKGROUND...............................................................................................................2背景A.RegulatoryFramework.................................................................................................................2法规架构B.TechnicalFramework....................................................................................................................3技术架构III.SCOPE...............................................................................................................................4适用范围IV.BUILDINGSANDFACILITIES....................................................................................6厂房和建筑A.CriticalArea–Class100(ISO5).................................................................................................8关键区域–100级(ISO5)B.SupportingCleanAreas..............................................................................................................11辅助洁净区域C.CleanAreaSeparation................................................................................................................11净化区的隔离D.AirFiltration................................................................................................................................12空气过滤1.Membrane......................................................................................................................................13膜过滤2.High-EfficiencyParticulateAir(HEPA).......................................................................................14高效颗粒空气过滤器(HEPA)E.Design............................................................................................................................................16设计V.PERSONNELTRAINING,QUALIFICATION,&MONITORING........................20人员的培训，资格认定和监控A.Personnel.......................................................................................................................................21人员B.LaboratoryPersonnel..................................................................................................................25实验室人员C.MonitoringProgram....................................................................................................................25监控程序VI.COMPONENTSANDCONTAINER/CLOSURES....................................................27药品成分和容器/密封A.Components..................................................................................................................................27ContainsNonbindingRecommendationsCopyrightSCIVersion1药品成分B.Containers/Closures.....................................................................................................................30容器/密封1.Preparation....................................................................................................................................30准备2.InspectionofContainerClosureSystem........................................................................................32容器密封系统的检查VII.ENDOTOXINCONTROL.............................................................................................34内毒素控制VIII.TIMELIMITATIONS...................................................................................................36时间限制IX.VALIDATIONOFASEPTICPROCESSINGANDSTERILIZATION..................37无菌加工和灭菌的验证A.ProcessSimulations.....................................................................................................................37工艺模拟1.StudyDesign.................................................................................................................................38研究设计2.FrequencyandNumberofRuns..........................