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1、最新资料推荐Guidance for Industry行业指南Process Validation: GeneralPrinciples and Practices工艺验证:一般原则与规范U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)J
2、anuary 2011Current Good Manufacturing Practices (CGMP)Revision 1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 infoGuidance for Industry行业指南Process Validation: GeneralPrinciples and Practices工艺验证:一般原则与规范Additional copies are ava
3、ilable from:Office of CommunicationsDivision of Drug Information, WO51, Room 220110903 New Hampshire Ave.Silver Spring, MD 20993Phone: 301-796-3400; Fax: 301-847-8714druginfofda.hhs.govwww.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOffice of Communication, Outre
4、ach and Development, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448(Tel) 800-835-4709 or 301-827-1800www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orCommunications Staff
5、, HFV-12Center for Veterinary MedicineFood and Drug Administration7519 Standish Place,Rockville, MD 20855(Tel) 240-276-9300www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm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 info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
6、室,邮政编码:20993电话:301-796-3400; 传真:301-847-8714druginfofda.hhs.govwww.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm和/或马里兰州洛克维尔市洛克维尔大道1401号 HFM-40 FDA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 301-827-1800www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceR
7、egulatoryInformation/Guidances/default.htm和/或马里兰州洛克维尔市Standish Place 7519号食品药品管理局兽药中心HFV-12通讯处,邮政编码:20885电话:240-276-9300www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Ev
8、aluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)January 2011Current Good Manufacturing Practices (CGMP)Revision 1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 i
9、nfoTable of Contents目录I. INTRODUCTION . 1一. 简介 . 1II. BACKGROUND . 3二. 背景 . 3A. Process Validation and Drug Quality . 4A. 工艺验证与药品质量 . 4B. Approach to Process Validation . 5B. 工艺验证方法 . 5III. STATUTORY AND REGULATORY REQUIREMENTS FOR PROCESS VALIDATION . 7三. 对工艺验证的法规和监管要求 . 7IV. RECOMMENDATIONS . 9四. 建议 . 9A. General Considerations for Process Validation . 9A. 对工艺验证的总体考虑 . 9B. Stage 1 - Process Design . 10B. 第一阶段 - 工艺设计 . 101. Building and