WHO GMP补充指南验证(中英对照)教程方案.doc

Annex 4 附件 4 Supplementary guidelines on good manufacturing practices: validation 药品生产质量管理规范补充指南：验证 Introduction  简介 Scope 范围 Glossary  术语 Relationship between validation and quali?cation  验证和确认之间的联系 5. Validation 5.1. Approaches to validation  验证方法 5.2. Scope of validation  验证范围 Quali?cation 确认 Calibration and veri?cation  校准和 Validation master plan  验证主计划 Quali?cation and validation protocols  确认和验证方案 Quali?cation and validation reports  确认和验证报告 Quali?cation stages  确认程序 Change control  变更控制 Personnel  人员 Referen