2011版FDA最新工艺验证指南

FDA工艺验证指南新旧版透彻比较解读【整理者提醒】1-左侧文本为2011年1月最新修订版本，右侧文本为2008年11月草案版本。

2-蓝色文本为修订后文本或者新增加文本。

3-下划线文本是比旧版本增加的部分内容。

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5-注释前面加【注释】2字注明。

6-Zhulikou431关于FDA2008年11月草案彻底解读版本可以在丁香园论坛搜索到，欢迎下载阅读、讨论。

7-不得用于商业用途，转载请注明丁香园信息。

8-增加了新旧版本的中文译文。

9-欢迎各位朋友提出宝贵建议，联系邮箱zhulikou431@.Guidance for IndustryProcess Validation: General Principles and PracticesFinal Version January 2011 Draft 2008I. INTRODUCTIONI. INTRODUCTION简介This guidance outlines the general principlesand approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in thisguidance as drugs or products. This guidanceincorporates principles and approaches thatall manufacturers can use to validate manufacturing processes.本指南概括了一般的原则与方法，这些原则与方法是FDA 认为进行工艺验证的恰当要素，这些工艺被用于生产人用药、动物用药以及生物制品，包括活性药物成分(API 或药用物质)，在本指南中以上统称为药品或产品。

本指南整合了一般的原则和方法，所有的生产企业都可以将这些原则和方法应用于生产工艺的验证。

This guidance outlines the general principles and approaches that FDA considers to be appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (API or drug substance),collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use in validating amanufacturing process. 本指南概括了一般的原则与方法，这些原则与方法是FDA 认为进行工艺验证的恰当要素，这些工艺被用于生产人用药、动物用药以及生物制品，包括活性药物成分(API 或药用物质)，在本指南中以上统称为药品或产品。

本指南整合了一般的原则和方法，所有的生产企业都可以将这些原则和方法应用于生产工艺的验证。

This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.2 Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk man- agement, and quality systems at all stages of the manufacturing process lifecycle. 本指南将工艺验证活动与产品生命周期概念以及现有FDA 相关指南进行了协调；这些存在的FDA指南包括FDA/ICH指南，Q8(R2)药品研发指南、Q9质量风险管理指南和Q10制药质量体系指南。

尽管本指南没有重复上述指南解释的概念和This guidance aligns process validation activities with the product lifecycle concept and with existing FDA guidance.2 2 See the FDA/International Conference on Harmonisation (ICH) guidances for industry: Q8 Pharmaceutical Development, Q9 Quality Risk Management, and when finalized, Q10 Pharmaceutical Quality System (a notice of availability for the May 2007 ICH draft guidance, Q10 Pharmaceutical Quality System, published in the Federal Register on July 13, 2007 (72 FR 38604)). We update guidance documents periodically. To make sure you have the most recent version of a guidance, check the CDER guidance page at /cder/guidance/index.htm, the CBER guidance page at原则，FDA鼓励在药品制造工艺生命周期的各个阶段使用现代药品研发概念、质量风险管理和质量体系概念。

注释2To make sure you have the most recent version of a guidance, check the CDER guidance page at /Drugs/GuidanceComplianceR egulatoryInformation/Guidances/default.htm, the CBER guidance page at/BiologicsBloodVaccines/Guida nceComplianceRegulatoryInformation/Guidances/default.htm, or the CVM guidance page at/AnimalVeterinary/GuidanceCo mplianceEnforcement/GuidanceforIndustry/default.htm/cber/guidelines.htm, or the CVM guidance page at /cvm/Guidance/published.htm . 本指南将工艺验证活动与产品生命周期概念以及现有FDA 相关指南（这里指得是Q8、Q9和Q10指南）进行了协调。

The lifecycle concept links product and process development, qualification of the commercial manufacturing process,3 andmaintenance of the process in a state of controlduring routine commercial production.This guidance supports process improvementand innovation through sound science.生命周期概念将产品与工艺开发、商业生产工艺的确认以及维护工艺在日常商业生产中处于受控状态连结在一起。

本指南通过足够科学知识来支持工艺优化和革新。

注释 3 In this guidance, the term commercialmanufacturingprocess refers to the manufacturingprocess resulting in commercial product (i.e., drugthat is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the term commercial manufacturing process does not include clinical trial or treatment IND material. The lifecycle concept links product andprocess development, qualification of thecommercial manufacturing process, andmaintenance of the process in a state of controlduring routine commercial production.This guidance promotes modern manufacturingprinciples, process improvement, innovation,and sound science.生命周期概念将产品与工艺开发、商业生产工艺的确认以及维护工艺在日常商业生产中处于受控状态连结在一起。