欧盟GMP.docVIP

欧盟GMP(EUGMP)欧洲药品生产和质量管理规范附录15验证和确认 EU GMP ANNEX 15 Qualification and validation (July 2001) ACUANNEX 15? 附件15Qualification 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. Processs 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 Principle 原理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理，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 制定验证计划1. 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. 左右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。2. 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。3. The VMP should contain data on at least the following: VMP应该至少包括以下数据：(a) validation policy; 验证方针(b) organisational structure of validation activities; 验证组织构架(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4. In case of large projects, it may be necessary to create separate validation master plans. 如果项目庞大，则需要制定分开的验证主计划。DOCUMENTATION