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 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 ANNEX 15 附件 15 Qualification and Validation Qualification and Validation 确认和验证 确认和验证 Table of Contents 目录 Table of Contents 目录 1. Qualification and Validation 确认和验证 1. Qualification and Validation 确认和验证 2. Planning for Validation 验证计划 2. Planning for Validation 验证计划 3. Documentation 文件 3. Documentation 文件 4. Qualification 确认 4. Qualification 确认 5. Process Validation 工艺验证 5. Process Validation 工艺验证 6. Cleaning Validation 清洁验证 6. Cleaning Validation 清洁验证 7. Change Control 变更控制 7. Change Control 变更控制 8. Revalidation 再验证 8. Revalidation 再验证 9. Glossary 术语表 9. Glossary 术语表 Qualification and Validation 确认和验证 Qualification and Validation 确认和验证 Principle 原理 Principle 原理 1.This Annex describes the principles of qualification and validation which are 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 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 that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of 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 the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation. determine the scope and extent of validation. 1.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 1.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