Annex 15Qualification and Validation(附件15确认与验证)正式版中英文对照

上海万逸医药科技有限公司刘伟强译Ref. Ares(2015)1380025 - 30/03/2015EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETYMedicinal Products – Quality, Safety and EfficacyBrussels, 30 March 2015EudraLexVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary Use欧盟人用及兽用药品GMP指导原则Annex 15: Qualification and Validation附件15：确认与验证Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/ECon 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 guidelinesof good manufacturing practice (GMP) for medicinal products as laid down in Directive2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.Status of the document: Revision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 Annexto reflect this changed environment. This revision to Annex 15 takes into account changesto other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.变更原因：附录15至2001年颁布以来，制造业和法规环境发生了显著变化，因此需要更新附录以反应这些环境的变化，附录15的修订还考虑到了欧盟药品监管法规（Eudralex）第四卷第一部分、第二部分有关内容、附录11、ICH Q8、Q9、Q19和Q11、欧盟药品质量工作组（QWP）工艺验证指南的变更以及制造技术变化等因素。

Deadline for coming into operation: 1 October 2015实施日期：2015年10月1日Principle原则This Annex describes the principles of qualification and validation which are 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 that 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 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 be taken into account.本附件描述的相关原则，既适用于用于生产医药产品的厂房、设施，设备以及工艺的确认与验证活动，也可用于在欧盟药品监管法规（Eudralex）第四卷第二部分没有导入附加要求的活性物质的补充可选指南。

GMP要求企业在贯穿产品和工艺的生产周期过程中通过确认与验证控制有关操作的关键要素。

任何计划对厂房、设施、设备和工艺进行变更可能会影响产品质量时，应当采用正式记录的方式对验证状态和控制策略进行评估。

用于医药产品生产的计算机化系统应按照附件11的要求进行验证。

本文件也考虑了ICH Q8、Q9、Q10和Q11的相关的概念和指导。

General通用要求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 qualification and validation should be based on a justified and documented risk assessment of the facilities, equipment, utilities 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 there is adequate assurance that controls were in place throughout the acquisition of such data.质量风险管理方法应当贯穿于整个医药产品生命周期。

作为质量风险管理系统的一部分，应对厂房、设施、设备工艺确认与验证的范围和程度进行风险评估。

回顾性验证不再认为是可以接受的方式。

用于支持确认和或验证研究的数据是通过外部途径获取的，企业应当对获取数据对外部的途径进行评估，并充分保证在数据获取的整个过程中都处于控制状态。

ANISING AND PLANNING FOR QUALIFICATION ANDVALIDATION确认与研制的组织和计划1.1.All qualification and validation activities should be planned and take the lifecycle of facilities, equipment, utilities, process and product into consideration.所有确认与验证活动应在设备、工艺、产品的生命周期中有计划地实施1.2.Qualification and validation activities should only be performed by suitably trainedpersonnel who follow approved procedures.确认与验证活动应由被进行适当培训的人员按照批准的程序实施1.3.Qualification/validation personnel should report as defined in the pharmaceuticalquality system although this may not necessarily be to a quality management or a quality assurance function. However, there should be appropriate quality oversight over the whole validation life cycle.药品质量管理体系规定确认/验证人员应进行报告，不过在质量管理和质量保证的职责中可能不是必须的，但需要在整个验证生命周期中进行适当的质量监控。