fda无菌生产指南 中英文对照版

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1、Translatedfrom/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.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCopyrightSCIVersion1CenterforDrugEvaluationand

2、Research(CDER)CenterforBiologicsEvaluationandResearch(CBER)OfficeofRegulatoryAffairs(ORA)September2004PharmaceuticalCGMPsCopyrightSCIVersion1GuidanceforIndustrySterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingPracticeAdditionalcopiesare

3、availablefrom:OfficeofTrainingandCommunicationDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573http://www.fda.gov/cder/guidance/index.htmorOfficeofCommunication,Train

4、ingandManufacturersAssistance,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448http://www.fda.gov/cber/guidelines.htm.(Tel)VoiceInformationSystemat800-835-4709or301-827-1800U.S.DepartmentofHealthan

5、dHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)OfficeofRegulatoryaffairs(ORA)September2004PharmaceuticalCGMPsCopyrightSCIVersion1CopyrightSCIVersion1ContainsNonbindingRecommendation

6、sTABLEOFCONTENTSI.INTRODUCTION1简介II.BACKGROUND2背景A.RegulatoryFramework3法规架构B.TechnicalFramework3技术架构III.SCOPE4适用范围IV.BUILDINGSANDFACILITIES5厂房和建筑A.CriticalArea–Class100(ISO5)5关键区域–100级(ISO5)B.SupportingCleanAreas5辅助洁净区域C.CleanAreaSeparation5净化区的隔离D.AirFiltra

7、tion5空气过滤1.Membrane5膜过滤2.High-EfficiencyParticulateAir(HEPA)5高效颗粒空气过滤器(HEPA)E.Design5设计V.PERSONNELTRAINING,QUALIFICATION,&MONITORING5人员的培训，资格认定和监控A.Personnel5人员B.LaboratoryPersonnel5实验室人员C.MonitoringProgram5监控程序VI.COMPONENTSANDCONTAINER/CLOSURES5药品成分和容器/密封Co

8、pyrightSCIVersion1ContainsNonbindingRecommendationsA.Components5药品成分B.Containers/Closures5容器/密封1.Preparation5准备2.InspectionofContainerClosureSystem5容器密封系统的检查VII.ENDOTOXINCONTROL5内毒素控制VIII.TIMELI