欧盟GMP附录15：确认与验证(修订版英文+中文)

1.1.所有的确认和验证都应当被计划，并考虑到设施、设备、公用系统、工艺和产品的生命周期。
1.2.Qualification and validation activities should only be performed by suitably trained personnel who follow approved procedures.
iv.Change control and deviation management for qualification and validation;
iv.确认与验证活动的变更控制和偏差管理。
v. Guidance on developing acceptance criteria;
v.开发可接受标准的指南。
1.4.应当在验证主计划（VMP）或其等同文件中，清晰地界定和记录现场确认与验证程序的关键性要素。
1.5. The VMP or equivalent document should define the qualification/validation system and include or reference information on at least the following:
Pharmaceuticals and cosmetics
Brussels,30 March 2015
EudraLex
欧盟药品管理法
Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and 险管理的方法应作为质量风险管理系统的一部分贯穿于药品的整个生命周期，应基于对设施、设备、公用系统和工艺的论证和书面风险评估决定确认和验证的范围和程度。回顾性验证不再被认为是可接受的方式。如果方法经过论证，并且获取数据的整个过程中有足够的保证性控制措施，也可以使用从生产商自身程序以外获得的用于支持确认和/或验证研究的数据。
vi.References to existing documents;
vi.现有文件的参考资料。
vii.The qualification and validation strategy, including requalification, where applicable.
vii.确认与验证的策略，适当时应包括再确认。
1.5.验证主计划或其等同文件中应定义确认/验证体系，至少包括如下信息：
i. Qualification and Validation policy;
i.确认与验证的方针政策。
ii. The organisational structure including roles and responsibilities for qualification and validation activities;
1.2.确认和验证活动应只能由经过培训合格的人员严格按照批准的程序实施。
1.3.Qualification/validation personnel should report as defined in the pharmaceutical quality 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.
原则
本附录描述了确认与验证的基本原则，适用于药品生产中的设施、设备、公用系统及工艺,也可以用于第四卷第二部分《活性物质作起始物料》的附加要求中没有介绍部分的补充性、选择性指南。GMP要求生产商应通过确认和验证对整个生命周期内的产品和工艺涉及的关键操作中的关键因素来进行控制。所有影响产品质量的计划性变更（含设施、设备、工艺系统和工艺），都应当有正式文件或记录，并评估其对验证状态或是控制策略的影响。用于药品生产的计算机化系统也应根据附录11的要求进行验证。同时，应当考虑现行的ICH Q8、Q9、Q10、Q11中的相关理念和指南要求。
General
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 validationshould 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.
1.6.For large and complex projects, planning takes on added importance and separate validation plans may enhance clarity
第四卷欧盟人用和兽用药品GMP指南
Annex 15: Qualification and Validation
附录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 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 good 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.
ii.在确认和验证活动中的组织结构，包括分工和职责。
iii.Summary of the facilities, equipment, systems, processes on site and the qualification and validation status;
iii.现场设施、设备、系统、工艺汇总表及其确认和验证状态。
发布该细化指南的法律依据:人用药物欧共体法案指令2001/83/EC第47章和兽用药物欧共体
Principle
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.