1、FDA最新工艺验证指南1版中文版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 Medic
2、ine (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 *Guidance for Industry行业指南Process Validation: GeneralPrinciples and Practices工艺验证:一般原则与规范Additional copies
3、are available from:Office of CommunicationsDivision of Drug Information, WO51, Room 220110903 New Hampshire Ave.Silver Spring, MD 20993Phone: 301-796-3400; Fax: 301-847-8714*.govwww.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOffice of Communication, Outreach and
4、 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, HFV-1
5、2Center 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 *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:209
6、93电话:301-796-3400; 传真:301-847-8714*.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/GuidanceComplianceRegulatoryInformation/Gui
7、dances/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 Evaluation and Research (C
8、DER)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 *Table of ContentsI. INTR
9、ODUCTION . 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 Consideratio
10、ns 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 Capturing Process Knowledge and Understanding . 111. 建立和捕获工艺知识与理解 . 112. Establishing a Strategy for Process Control . 122. 建立工艺控制策略 . 12C. Stage 2 - Process Qualification . 14C. 第二阶段 - 工
11、艺确认 . 141. Design of a Facility and Qualification of Utilities and Equipment . 141. 厂房设施设计以及公用设施与设备确认 . 142. Process Performance Qualification . 162. 工艺性能确认 . 163. PPQ Protocol . 173. 工艺性能确认方案 . 174. PPQ Protocol Execution and Report . 194. 工艺性能确认执行与报告 . 19D. Stage 3 - Continued Process Verification
12、 . 20D. 第三阶段 - 持续工艺验证 . 20V. CONCURRENT RELEASE OF PPQ BATCHES . 22五. 工艺性能确认批次的同时放行 . 22VI. DOCUMENTATION . 24六. 文件记录 . 24VII. ANALYTICAL METHODOLOGY . 24七. 分析方法 . 24GLOSSARY . 26术语表 . 26REFERENCES. 28参考资料. 28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 *1Guidance for Industry1行业指南1Process Validation: General Pri
13、nciples and Practices工艺验证:一般原则与实施This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It doesnot create or confer any rights for or on any person and does not operate to bind FDA or the public. You canuse an alternative approach if the approach satisfies
14、the requirements of the applicable statutes andregulations. If you want to discuss an alternative approach, contact the FDA staff responsible forimplementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate numberlisted on the title page of this guidance.本指南体现了食品
15、药品管理局(FDA)关于这一主题的最新见解。本指南不为任何人或对任何人才创造或赋予任何权利,不起束缚FDA 或公众的作用。如果替代方法能够满足适用法律、法规的要求,您可以使用替代方法。如果您希望讨论一种替代性方法,请与负责执行本指南的FDA 工作人员联系。如果您不能确定相应的FDA 工作人员,请拨打本指南标题页所列的相应电话号码。I. INTRODUCTION一. 简介This guidance outlines the general principles and approaches that FDA considers appropriate elements ofprocess val
16、idation for the manufacture of human and animal drug and biological products, including activepharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs orproducts. This guidance incorporates principles and approaches that all manufacturers can use to validatemanufacturing processes.本指南概述了FDA 认为是包括原料药在内的人与动物用药和生物制品(在本指南中合称为药品或制品)生产工艺验证相应要素的一般原则和方法。该指南收编了所有生产商可用于验证生产工艺的多种原则和方法。This guidance aligns process validatio
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