2011版FDA工艺验证指南中英文版

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...........................................................................................................................................................1 II. BACKGROUND..........................................................................................................................................3 二. 背景...........................................................................................................................................................3 A. ProcessValidationandDrugQuality..................................................................................................4 A. 工艺验证与药品质量....................................................................................................................4 B. ApproachtoProcessValidation.........................................................................................................5 B. 工艺验证方法.................................................................................................................................5 III. STATUTORYANDREGULATORYREQUIREMENTSFORPROCESSVALIDATION...............................7 三. 对工艺验证的法规和监管要求...........................................................................................................7 IV. RECOMMENDATIONS...............................................................................................................................9 四. 建议...........................................................................................................................................................9 A. GeneralConsiderationsforProcessValidation..................................................................................9 A. 对工艺验证的总体考虑...............................................................................................................9 B. Stage1-ProcessDesign.................................................................................................................10 B. 第一阶段-工艺设计.................................................................................................................10 1. BuildingandCapturingProcessKnowledgeandUnderstanding............................................11 1. 建立和捕获工艺知识与理解............................................................................................11 2. EstablishingaStrategyforProcessControl............................................................................12 2. 建立工艺控制策略.............................................................................................................12 C