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1、 翻译：武晋娴 校对：陈国笋 1 / 22 此译文仅供学习之用，如有翻译不当，可参考英文原文。 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use 人用与兽用药品的生产质量管理规范的欧盟指南人用与兽用药品的生产质量管理规范的欧盟指南 Annex 15: Qualification and Validation 附录附录 15：确认与验证：确认与验证 Legal basis for publishing the detailed guidelines:
2、Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use 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 goo
3、d manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. 发布详细指南的法律依据：发布详细指南的法律依据： 欧盟法规有关人用药品的第 2001/83/EC 法令的第 47 条和有关兽 用药品的第 2001/82/EC 法令的第 51 条。本文件提供指南，用以解释在人用药品的第 2003/94/EC 法令和兽用药
4、品的第 91/412/EEC 法令下的药品的生产质量管理规范的原则和指 导。 Status of the document: Revision 文件状态：文件状态：修订 Reasons for changes: Since Annex 15 was published in 2001 the manufacturing and regulatory environment has changed significantly and an update is required to this Annex to reflect this changed environment. This revi
5、sion to Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. 变更原因：变更原因：自从 2001 年附录 15 发布以后，生产和法规环境已经显著变化，本附录也需要 进行更新，以反映变化的环境。本
6、附录 15 的修订版考虑了欧盟药品法规第 4 卷，第 I 部分 的其它章节的变化，第 II 部分的相应章节、附录 11、ICH Q8、Q9、Q10 和 Q11，QWP 有关 工艺验证的指南，以及生产技术的变化。 Deadline for coming into operation: 1 October 2015 生效的最后期限：生效的最后期限：2015 年 10 月 1 日 翻译：武晋娴 校对：陈国笋 2 / 22 Principle 原则原则 This Annex describes the principles of qualification and validation which a
7、re applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement tha
8、t manufacturers 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 processes, which may affect the quality of the product, should be formally
9、documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also
10、be taken into account. 本附录描述了确认和验证的原则，适用于药品生产的设施、设备、公用系统和工艺；也可作 为在欧盟药品法规第四卷第 II 部的未提到的有额外要求的原料药的可选性补充指南。它是 GMP 的要求，要求生产商通过贯穿于药品和工艺的产品生命周期的确认和验证，控制其生 产操作的关键环节。需要正式记录任何可能影响药品质量的设施、设备、公用系统和工艺的 计划性变更， 需要评估对于验证状态或控制策略的影响。 用于药品生产的计算机化系统应按 照附录 11 的要求进行验证。相关概念和指南参见 ICH Q8，同时参考 Q10 和 Q11。 General 通则通则 A qual
11、ity 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 qualification and validation should be based on a justified and documented risk assessment of the facilities, equipment, u
12、tilities and processes. Retrospective validation is no longer considered an acceptable approach. Data supporting qualification and/or validation studies which were obtained from sources outside of the manufacturers own programmes may be used provided that this approach has been justified and that th
13、ere is adequate assurance that controls were in place throughout the acquisition of such data. 质量风险管理的方法应该贯穿于药品生命周期的全过程。作为质量风险管理系统的一部分， 确认和验证的范围和程度需要基于对设施、 设备、 公用系统和工艺的合理的文件化的风险评 估来确定。回顾性验证不再被认为是一个可接受的方法。那些用来支持确认和/或验证研究 的从生产商的外部资源获得的数据，都可以被使用，但需提供证明这个方法合理性的说明， 并且保证在采集这些数据的过程中控制是恰当的。 1 ORGANISING AND
14、 PLANNING FOR QUALIFICATION AND VALIDATION 确认与验证的组织和计划确认与验证的组织和计划 1.1 All qualification and validation activities should be planned and take the life cycle of facilities, equipment, utilities, process and product into consideration. 应该计划所有的确认与验证活动，而且需要考虑设施、设备、公用系统、工艺和产 品的生命周期。 1.2 Qualification and
15、validation activities should only be performed by suitably trained personnel who follow approved procedures. 确认与验证活动应该只能由合适的经过培训的人员按照被批准的程序进行。 翻译：武晋娴 校对：陈国笋 3 / 22 1.3 Qualification/validation personnel should report as defined in the pharmaceutical quality system although this may not necessarily b
16、e to a quality management or a quality assurance function. However, there should be appropriate quality oversight over the whole validation life cycle. 尽管对于质量管理或者质量保证功能来说没有必要性， 但是确认/验证人员仍应该按 照药品质量系统的要求的进行汇报。而且应该对整个验证的生命周期有恰当的质量 监督。 1.4 The key elements of the site qualification and validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent document. 工厂确认与验证项目的关键要素，应该在验证主计划（VMP）或者等效文件中明确 定义并记录。 1.5 The VMP
