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EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines for Good Manufacturing Practice
for Medicinal Products for Human and Veterinary U
Annex 15: Qualification and Validation
欧盟人用及兽用药品GMP指导原则
附件15：确认和验证
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human u and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human u and Directive 91/412/EEC for veterinary u.
Status of the document: Revision 1 文件状态：修订
Propod document time table:
Reasons for changes: Update as per concept paper on revision of Annex 15.
Summary of changes: This change to annex 15 takes into account changes to other ctions of the EU-GMP Guide Part I, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation and changes in manufacturing technology.
变更概述：附件15的变更综合考虑了EU GMP 第一部分附件11，ICH Q8, Q9, Q10 and
Q11, QWP指南中关于工艺验证的变更内容以及生产技术的变化。
Deadline for coming into operation: to be determined.
生效时间：待定
重要的修订内容：
本附件综合了ICH Q8制药研发， Q9质量风险管理， Q10制药质量体系，Q11原料药研发制造的内容。
●引入新的术语，例如进行中验证策略（ongoing validation strategy）；
●回顾性验证和再验证的概念已经删除；
●在设备使用中，关于设备确认的信息几乎被忽略；
●增加运输确认的命名，包装验证；
●设施验证和分析方法验证有新的要求；
●工艺验证有2种不同的方法，一种是现代的“持续验证”方法，另一种是传统方法。但在任
发光的人何情况下，应当证明工艺的耐用性；
●工艺验证的分组方法（"Bracketing" approaches）；
●在工艺持续确认与传统工艺验证之间的混合方法仍然有些模糊（fuzzy）；
●关于清洁验证的“清洁”标准不再是唯一的标准；
●设备清洁验证的分组具有了明确的可能性，但需要创建；
●清洁验证的接受标准取绝于毒理数据PDE(permitted daily exposure 每天允许暴露量)；
●清洗验证的批次根据风险评估来决定，不在强求进行3个批次；
●生产批次很少的产品，对于清洁验证的理念也有了新的要求；
●要求研究和制定的清洁后的有效期；
Table of content 目录
Principle 原则 (4)
General 通则 (5)
1ORGA NISING A ND PLA NNING FOR QUA LIFICA TION A ND VA LIDA TION (5)
确认、验证的组织和计划 (5)
2DOCUMENTA TION INCLUDING VMP 文件，包括V MP (7)
路由交换技术
3QUA LIFICA TION STA GES FOR EQUIPMENT, FA CILITIES A ND UTILITIES (8)
设备、设施和公用系统确认阶段 (8)
4PROCESS VA LIDA TION 工艺验证 (11)
5VERIFICA TION OF TRA NSPORTA TION 运输确认 (18)
处女男性格分析6VA LIDA TION OF PA CKA GING 包装验证 (19)
7VA LIDA TION OF UTILITIES 公用系统验证 (19)
8VA LIDA TION OF TEST METHODS 检验方法验证 (20)
hotspare9CLEA NING VA LIDA TION 清洁验证 (20)
10RE-QUA LIFICA TION 再确认 (23)
11CHA NGE CONTROL 变更控制 (23)
GLOSSA RY 术语 (24)文字传播
QUALIFICATION AND VALIDATION 确认和变更
Principle 原则
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and process ud for the manufacture of medicinal products. It is a GMP requirement that manufacturer’s control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process.
Any planned changes to the facilities, equipment, utilities and process, which may affect the qualit
y of the product, should be formally documented and the impact on the validated status or control strategy assd. Computerid systems ud for the manufacture of medicinal products should be validated according to the requirements of Annex 11. The relevant concepts and guidance prented in ICH Q8, Q10 and Q11 should also be taken into account.
黄花菜的功效.本附件描述了确认和验证的原则，本原则适用于药品生产的施舍、设备、公用系统和工艺。
是生产商通过产品和工艺整个生命周期进行确认和验证对生产操作关键方面进行控制的GMP
要求。在设施、设备和工艺等，对产品质量会产生重大影响计划变更需要进行记录，对验证状态或者控制策略进行评估。药品生产中使用的计算机化系统需要根据附件11的要求进行验证。相关概念在ICH Q8有呈现, 并综合考虑了Q10 以及Q11指南中的相关概念。
General 通则
新时代新思想A quality risk management approach should be applied throughout the lifecycle of a medicinal product. As part of a quality risk management system, decisions on the scope and extent of validation and qualification should be bad on a justified and documented risk asssment of the facilities, equipment, utilities and process. The principles in ICH Q8, Q9, Q10 and Q11 or other sys
tems guaranteeing at least the same level of product quality and curity should be ud to support validation and qualification activities.
质量风险管理方法应该应用与整个药品的生命周期中。作为质量风险管理体系的一部分，确认和验证范围及程度的决定应该基于对设施、设备、公用系统和工艺的评估，评估应合理并有文件记录。应当使用ICH Q8, Q9, Q10 ，Q11以及其他能保证至少相同质量水平和安全的文件
以支持确认和验证活动。
Data supporting qualification and/or validation studies which were obtained from sources outside of the manufacturers own validation programme may be ud provided that this approach has been justified and that there is adequate assurance that controls were in place throughout the acquisition of such data.
来自公司自己验证项目以外的数据可以用于支持确认/验证研究，只要此数据的验证方法合理圣经经典语录
并对数据的获得过程中有足够的保证。
1 ORGANISING AND PLANNING FOR QUALIFICATION AND VALIDATION
确认、验证的组织和计划
1.1 All qualification and validation activities should be planned and take the life cycle of
equipment, process and product into consideration.
所有的确认和验证活动都要进行计划，考虑设备、工艺和产品的证明周期。
