EU GMP指南附件15：确认和验证

EU GMP 指南附件 15:确认和验证(中英文)EU GMP 指南附件 15:确认和验证(中英文)

EUROPEAN COMMISSIONENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics

Brussels, July 2001

Working Party on Control of Medicines and Inspections Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice 欧盟 GMP 附件 15 终稿 Title: Qualification and validation 题目：确认和验证First discussion in drafting group 起草组的初步讨论 Discussion at the working Party on Control of Medicines and Inspection for release for consultation 药物控制和检查工作组讨论 Pharmaceutical Committee 药物委员会 Released for consultation 讨论稿完成 Deadline for comments 征求意见结束 Final approval by Inspector’s working party 检查官工作组最终批准 Pharmaceutical Committee (for information) 药物委员会(供参考) Date for coming into operation 实施日期 16 September 1999

28 September 1999 30 October 1999 28 February 2000 December 2000 April 2001 September 2001

Note that this document is based in the PICS/S recommendations

注意本文件基于PICS/S建议。

Table of Contents 目录

Page页

1. Qualification and Validation 确认和验证 3

2. Planning for Validation 验证计划 4

3. Documentation 文件 4

4. Qualification 确认 5

5. Processs Validation. 工艺验证 6

6. Cleaning Validation 清洁验证 7

7. Change Control 变更控制 8

8. Revalidation 再验证 9

9. Glossary 术语 10

QUALIFICATION AND VALIDATION 确认和验证

Principle 原则

1. This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation. 本附件描述了确认和验证的原则，应用于药品生产。GMP要求生产者应识别需要进行哪些验证工作，以证明其特定操作中对关键方面的控制。对设施、设备和工艺的重大变更，如果对产品质量产生影响，应进行验证。可以采用评估的方法决定验证的范围和深度。

PLANNING FOR VALIDATION 验证计划

2. All validation activities should be planned. The key elements of a validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent documents. 所有验证活动均应有计划。一个验证项目的关键要素应进行清楚界定，并在验证主计划（VMP）或相关文件中记录。

3. The VMP should be a summary document which is brief, concise and clear. 验证主计划是一个概述性文件，应简明扼要。

4. The VMP should contain data on at least the following: 验证主计划应最少包括以下内容 (a) validation policy; 验证方针

(b) organisational structure of validation activities; 验证活动的组织结构

(c) summary of facilities, systems, equipment and processes to be validated; 将验证的设施、系统、设备和工艺的概述

(d) documentation format: the format to be used for protocols and reports; 方案和报告的文件格式

(e) planning and scheduling; 计划和时间表

(f) change control; 变更控制

(g) reference to existing documents. 参考文献

5. In case of large projects, it may be necessary to create separate validation master plans. 如果是一个大项目，可能需要创建一个单独的验证主计划

DOCUMENTATION 文件

6. A written protocol should be established that specifies how qualification and validation will be conducted. The protocol should be reviewed and approved. The protocol should specify critical steps and acceptance criteria. 应有书面的验证方案说明如果实施确认和验证。方案应经过审核和批准，应说明关键步骤和可接受标准。

7. A report that cross-references the qualification and/or validation protocol should be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the necessary conclusions, including recommending changes necessary to correct deficiencies. Any changes to the plan as defined in the protocol should be documented with appropriate

justification. 应起草一份与确认和/或验证方案交叉索引的报告，总结所得到的结果，对所有偏差进行评价，作出结论，包括必要时建议的变更以纠正缺陷。对方案中计划的任何变更均应记录并作出适当的评价。

8. After completion of a satisfactory qualification, a formal release for the next step in

qualification and validation should be made as a written authorisation. 在一个令人满意的确认完成后，应有一个正式的书面批准，确认和验证方可进行下一步骤。

QUALIFICATION 确认

Design qualification 设计确认

9. The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). 新的设施、系统或设备验证的首个要素是设计确认（DQ）。

10. The compliance of the design with GMP should be demonstrated and documented. 应论证设计符合GMP要求并记录。

Installation qualification 安装确认

11. Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment. 新的或经过改造的设施、系统和设备应进行安装确认（IQ）。

12. IQ should include, but not be limited to the following: 安装确认应包括，但不仅限于以下内容

(a) installation of equipment, piping, services and instrumentation checked to current engineering drawings and specifications; 应将设备、管道、支持系统和建设的安装情况按照现行的工程图纸和要求进行检查；

(b) collection and collation of supplier operating and working instructions and maintenance requirements; 收集和核对供应商的操作和工作指令和维护要求

(c) calibration requirements; 校正要求

(d) verification of materials of construction. 建筑材料的确认

Operational qualification 运行确认

13. Operational qualification (OQ) should follow Installation qualificatio …… 此处隐藏：18465字，全部文档内容请下载后查看。喜欢就下载吧 ……