WHO制药用水中英对照版.pdf

WHO 良好的生产实践(GMP): 制药用水篇  © World Health Organization 世界卫生组织 WHO Technical Report Series, No. 929, 2005 世界卫生组织报告系列No. 929, 2005 Annex 3 附件3 WHO Good Manufacturing Practices: water for pharmaceutical use WHO 良好的生产实践(GMP): 制药用水篇 1. Introduction 简介 1.1 Scope of the document 文件范畴 1.2 Background to water requirements and uses 水质要求和使用背景 1.3 Applicable guides 应用指南 2. General requirements for pharmaceutical water systems 制药用水系统基本要求 3. Water quality specifications 水质规定 3.1 General 概要 3.2 Drinking-water 饮用水 3.3 Purified water 纯水 3.4 Highly purified water 高纯水 3.5 Water for injections 注射用水 3.6 Other grades of water 其他用水 4. Application of specific waters to processes and dosage forms 水在工艺和剂型中的应用 5. Water purification methods 水净化方式 5.1 General considerations总则 5.2 Production of drinking-water 饮用水制备 5.3 Production of purified water 纯化水制备 5.4 Production of highly purified water 高纯水制备 5.5 Production of water for injections 注射用水制备 6. Water purification, storage and distribution systems 水纯化,储备和分配系统 6.1 General 总则 6.2 Materials that come into contact with systems for water for pharmaceutical use 制药用水 系统的接触材料 6.3 System sanitization and bioburden control 系统消毒和微生物控制   1 / 32    WHO 良好的生产实践(GMP): 制药用水篇  6.4 Storage vessel requirements 储罐要求 6.5 Requirements for water distribution pipework 水分配管道要求 7. Operational considerations 操作要求 7.1 Start-up and commissioning of water systems 水系统启动和调试 7.2 Qualification 确认 7.3 Continuous system monitoring 持续系统监控 7.4 Maintenance of water systems 水系统维护 7.5 System reviews 系统评估 8. Inspection of water systems 水系统检查 Bibliography 参考书目  2 / 32    WHO 良好的生产实践(GMP): 制药用水篇  1. Introduction介绍 1.1 Scope of the document文件范畴 The guidance contained in this document is int