FDA行业指南工艺验证指南（中英文)

3.0 51zlzl 2025-11-26 7 503.73KB 44 页 200质量币

侵权投诉

FDA重要法规指南汇编(中英文对照)

276

GUIDANCE FOR INDUSTRY PROCESS VALIDATION:GENERAL

PRINCIPLES AND PRACTICES

工艺验证：一般原则与实施 1

This guidance represents the Food and Drug Administration's (FDA's)current thinking on this

topic.It does not create or confer any rights for or on any person and does not operate to bind

FDA or the public.You can use an alternative approach if the approach satisfies the requirements

of the applicable statutes and regulations.If you want to discuss an alternative approach,contact

the FDA staff responsible for implementing this guidance.If you cannot identify the appropriate

FDA staff,call the appropriate number listed on the title page of this guidance.

本指南代表了美国食品和药物管理局(FDA) 目前对这一主题的看法。它并不为任何人创造

或赋予任何权利，也不对 FDA 或公众具有约束力。如果替代方法符合适用法规和条例的要

求，您可以使用该方法。如果你想讨论替代方法，请联系负责实施本指南的 FDA 员工。如

果你找不到相应的 FDA 员工，请拨打本指南标题页上列出的相应号码。

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

1 This guidance has been prepared by the Division ofManufacturing and Product Quality,Center for Drug Evaluation

and Research(CDER),in cooperation with CDER's Office of Pharmaceutical Sciences,the Center for Biologics

Evaluation and Research(CBER),the Office ofRegulatory Affairs(ORA)and the Center for Veterinary Medicine

(CVM)atthe Food andDrugAdministration.本指南由美国食品和药物管理局药物评价与研究中心 (CDER)制造和

产品质量处与 CDER 药物科学办公室、生物制品评价与研究中心(CBER)、监管事务办公室 (ORA)和兽医中

心(CVM) 合作编写。

FDA重要法规指南汇编(中英文对照)

277

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.

本指南概述了 FDA 认为适用于人类和动物药物及生物制品(包括活性药物成分 (API 或药

物物质),在本指南中统称为药物或产品)生产过程验证的一般原则和方法。本指南包含了所

有生产商都可用于验证生产工艺的原则和方法。

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.²Although this guidance does not repeat the concepts and principles

explained in those guidances,FDA encourages the use of modern pharmaceutical development

concepts,quality risk management,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和现有FDA指南进行了结合，包括 FDA/ 人用药品

注册技术规范国际协调会议(ICH) 行业指南，Q8(R2)《药品开发》、Q9《质量风险管理》和Q10

《药品质量体系》。尽管本指南不复述那些指南解释的概念或原则，但FDA鼓励在药物工艺生

命周期所有阶段使用现代药物开发概念、质量风险管理和质量体系。

The lifecycle concept links product and process development,qualification of the commercial

manufacturing process,³and maintenance of the process in a state of control during routine

commercial production.This guidance supports process improvement and innovation through sound

science.

2 To make sure you have the most recent version of a guidance,check the CDER guidance page at

http://www.fda.gov/Drugs/GuidanceComplianceRegulatorylnformation/Guidances/default.htm,the CBER guidance page at

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,or the CVM

guidance page at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

3 In this guidance,the term commercial manufacturing process refers to the manufacturing process resulting in commercial product

(i.e,drug that 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.

FDA重要法规指南汇编(中英文对照)

278

生命周期概念将产品和工艺开发、商业化生产工艺的确认、以及在常规商业生产过程处于受控

状态。本指导原则通过合理的科学方法支持工艺改进和创新。

This guidance covers the following categories of drugs:

本指南涵盖下列类别的药物：

· Human drugs 人用药

.Veterinary drugs 兽用药

·Biological and biotechnology products 生物和生物技术制品

· Finished products and active pharmaceutical ingredients(APIs or drug substances)⁴

. 制剂产品和活性药物成分(原料药或药用物质)

·The drug constituent of a combination(drug and medical device)product 组合产品(药物

和医疗器械)的药物组分

This guidance does not cover the following types of products:

本指南不涵盖下列类型产品：

· Type A medicated articles and medicated feed

·A类添加药物产品或添加药物饲料

. Medical devices⁵

· 医疗器械

· Dietary supplements

4 Separate currentgood manufacturingpractice(CGMP)regulations for drug components such as APIs(drug substances)and intermediates have not publihed as ofthe date of this guidance,but thee

components are subject to the statutory CGMP requirements ofsection 501(a)(2)(B)of the Federal Food,Drug and Cosmetic Act(the Act)(21US.C.351()2)(B)Process validationfor APls is discussedin

the FDAICH guidance for industry,Q7 GoodMamufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICHQ7),avalable on the Intemet at

htp/ww fdagovDrug GuidaneComplianceRegulatorylnfomation Guidances/default hm.SectionXIIof ICHQ7 describes i detal te principles forvlidating APIprocess.

5 Guidanceon process vlidanion formedical devicesis providedin aseparate document,Quality Management Systems -ProcessValidation,edition 2,Se infranote 6.

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载

标签： #验证 #指南 #工艺验证

摘要：

FDA重要法规指南汇编(中英文对照)276GUIDANCEFORINDUSTRYPROCESSVALIDATION:GENERALPRINCIPLESANDPRACTICES工艺验证：一般原则与实施1ThisguidancerepresentstheFoodandDrugAdministration's(FDA's)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproa...

展开>> 收起<<

FDA行业指南工艺验证指南（中英文).pdf

共44页,预览44页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

FDA行业指南工艺验证指南（中英文)

相关推荐

相关内容

热门标签

举报选择:

FDA行业指南 工艺验证指南（中英文)

相关推荐

相关内容

热门标签

举报选择:

FDA行业指南工艺验证指南（中英文)