欧盟GMP附录15确认和验证中英文新版.pdf

欧盟 GMP 附录 15 确认和验证
欧盟 GMP 附录 15 确认和验证
ANNEX 15 附件 15
Qualification and Validation
确认和验证
Table of Contents 目录
1. Qualification and Validation 确认和验证
2. Planning for Validation 验证计划
3. Documentation 文件
4. Qualification 确认
5. Process Validation 工艺验证
6. Cleaning Validation 清洁验证
7. Change Control 变更控制
8. Revalidation 再验证
9. Glossary 术语表

Qualification and Validation 确认和验证
Principle 原理

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.
,适用于医药产品的生产者。这是 GMP指导生产者明
确他们整个操作中哪些是需要对其进行控制的关键方面。在设施、设备和工艺等,对
产品质量会产生重大影响的改变需要进行验证。风险评估用来进行验证的未来预测。

PLANNING FOR VALIDATION 验证计划
2. All validation activities should be planned. The key elements of a validation
program should be clearly defined and documented in a validation master plan
(VMP) or equivalent documents.
所有验证活动都要进行规划。验证计划的关键组成部分应该明确定义并在验证主计划
(VMP)或类似文件中写明。
3. The VMP should be a summary document which is brief, concise and clear.
VMP 是一个简短、简明而清晰的综述性文件。
4. The VMP should contain data on at least the following:
VMP 应该至少包括以下资料:
(a) Validation policy;
验证方针
(b) Organizational structure of validation activities;
验证组织机构
(c) Summary of facilities, systems, equipment and processes to be validated;
需要验证的设备、系统、仪器、工艺的汇总
(d) Documentation format: the format to be used for protocols and reports;
文件模版:制定草案和报告的模版
(e) Planning and scheduling;
计划和时间表
(f) Change control;
变更控制
(g) Reference to existing documents.
引用已有文件
5. In case of large projects, it may be necessary to create separate va