FDA最新工艺验证指南(XXXX1版)(中文版)

GuidanceforIndustry行业指南ProcessValidation:GeneralPrinciplesandPractices工艺验证：一般原则与规范U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1美国卫生与人类服务部食品药品管理局药物评价和研究中心（CDER）生物制品评价和研究中心（CBER）兽药中心（CVM）2011年1月现行药品质量生产管理规范（CGMP）修订版1包含不具约束力的建议中文译稿：北京大学药物信息与工程研究中心[e-mail]行业指南ProcessValidation:GeneralPrinciplesandPractices工艺验证：一般原则与规范Additionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room220110903NewHampshireAve.SilverSpring,MD20993Phone:[phone];Fax:[e-mail](Tel)800-835-4709or301-827-1800(Tel)240-276-9300包含不具约束力的建议中文译稿：北京大学药物信息与工程研究中心[e-mail]另外的副本可从以下部门得到：马里兰州银泉市新罕布什尔大道10193号2201室药品信息处，对外信息办公室，邮政编码：20993电话：301-796-3400;传真：[e-mail]和/或马里兰州洛克维尔市洛克维尔大道1401号HFM-40FDA生物制品评价和研究中心对外信息、外联与发展办公室邮政编码：20852-1448电话：800-835-4709或301-827-1800和/或马里兰州洛克维尔市StandishPlace7519号食品药品管理局兽药中心HFV-12通讯处，邮政编码：20885电话：240-276-9300(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1美国卫生与人类服务部食品药品管理局药物评估和研究中心（CDER）生物制品评估和研究中心（CBER）兽药中心（CVM）2011年1月现行药品质量生产管理规范（CGMP）修订版1包含不具约束力的建议中文译稿：北京大学药物信息与工程研究中心[e-mail]目录I.INTRODUCTION........................................................................................................................................1一.简介..........................................................................................................................................................1II.BACKGROUND.........................................................................................................................................3二.背景..........................................................................................................................................................3A.ProcessValidationandDrugQuality..................................................................................................4A.工艺验证与药品质量....................................................................................................................4B.ApproachtoProcessValidation.........................................................................................................5B.工艺验证方法................................................................................................................................5III.STATUTORYANDREGULATORYREQUIREMENTSFORPROCESSVALIDATION...............................7三.对工艺验证的法规和监管要求...........................................................................................................7IV.RECOMMENDATIONS...............................................................................................................................9四.建议..........................................................................................................................................................9A.GeneralConsiderationsforProcessValidation..................................................................................9A.对工艺验证的总体考虑...............................................................................................................9B.Stage1-ProcessDesign.................................................................................................................10B.第一阶段-工艺设计.................................................................................................................101.BuildingandCapturingProcessKnowledgeandUnderstanding............................................111.建立和捕获工艺知识与理解............................................................................................112.EstablishingaStrategyforProcessControl............................................................................122.建立工艺控制策略.............................................................................................................12C.Stage2-ProcessQualification..................