文档介绍：FDA无菌生产指南-中英文对照版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)(CDER)CenterforBiologicsEvaluationandResearch(CBER)OfficeofRegulatoryAffairs(ORA)September2004PharmaceuticalCGMPsGuidanceforIndustrySterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingPracticeAdditionalcopiesareavailablefrom:municationDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573r/guidance/,TrainingandManufacturersAssistance,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448r/.(Tel)VoiceInformationSystemat800-835-4709or301-827-(CDER)CenterforBiologicsEvaluationandResearch(CBER)OfficeofRegulatoryaffairs(ORA)September2004PharmaceuticalCGMPsTABLEOFCONTENTSI. Introduction 1 简介II. Background 2 背景A. RegulatoryFramework 3 法规架构B. TechnicalFramework 3 技术架构III. Scope 4 适用范围IV. BUILDINGSANDFACILITIES 5 厂房和建筑A. CriticalArea–Class100(ISO5) 5 关键区域–100级(ISO5)B. SupportingCleanAreas 5 辅助洁净区域C. CleanAreaSeparation 5 净化区的隔离D. AirFiltration 5 空气过滤1. Membrane 5 膜过滤2. High-EfficiencyParticulateAir(HEPA) 5 高效颗粒空气过滤器(HEPA)E. Design 5 设计V. PERSONNELTRAINING,QUALIFICATION,&MONITORING 5 人员的培训,资格认定和监控A. Personnel 5 人员B. LaboratoryPersonnel 5 实验室人员C. MonitoringProgram 5 监控程序VI. COMPONENTSANDCONTAINER/CLOSURES 5 药品成分和容器/密封A. Components 5 药品成分B. Containers/Closures 5 容器/密封1. Preparation 5 准备2. InspectionofContainerClosureSystem 5 容器密封系统的检查VII. ENDOTOXINCONTROL 5 内***控制VIII. TIMELIMITATIONS 5 时间限制IX. VALIDATIONofasepticprocessingandsterilization 5 无菌加工和灭菌的验证A. ProcessSimulations 5 工艺模拟1. StudyDesign 5 研究设计2. FrequencyandNumberofRuns 5 运行频率和