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Guidance for Industry

Process Validation: General Principles and Practices

Final Version January 2011 Draft 2008

I. INTRODUCTION

I. INTRODUCTION

简介

This guidance outlines the general principles

and 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 this

guidance as drugs or products. This guidance

incorporates principles and approaches that

all 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 a

manufacturing 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Risk Management, and when finalized, Q10 Pharmaceutical Quality System (a notice of availability for the May 2007 ICH draft guidance, Q10 Pharmaceutical Quality System, published in the Federal Register on July 13, 2007 (72 FR 38604)).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