WHO_TRS970_annex2(制药用水-对照版).pdfVIP

©World Health Organization WHO Technical Report Series, No. 970, 2012 Annex 2 附件2 Page 1 of 20 Annex 2 附件 2 WHO good manufacturing practices: water for pharmaceutical use WHO GMP ：制药用水 1. Introduction 介绍 1.1 Scope of the document 文件范围 1.2 Background to water requirements and uses 水的要求和使用背景 1.3 Applicable guides 适用的指南 2. General principles for pharmaceutical water systems 制药用水系统的一般原则 3. Water quality specifications 水质量标准 3.1 General 概述 3.2 Drinking-water 饮用水 3.3 Bulk purified water 散装纯化水 3.4 Bulk highly purified water 散装高纯水 3.5 Bulk water for injections 散装注射用水 3.6 Other grades of water 其它类型水 4. Application of specific types of water to processes and dosage forms 不同类型水在工艺和剂型中的应用 5. Water purification systems 水纯化系统 5.1 General considerations 一般考虑 5.2 Production of drinking-water 饮用水的制备 5.3 Production of purified water 纯化水的制备 5.4 Production of highly purified water 高纯水的制备 5.5 Production of water for injection(s) 注射用水的制备 6. Water storage and distribution systems 水存贮和分配系统 6.1 General 概述 6.2 Materials that come into contact with systems for water for pharmaceutical use 与制药用水系统接触的材质 6.3 System sanitization and bioburden control 系统消毒和微生物控制 6.4 Storage vessel requirements 贮罐要求 6.5 Requirements for water distribution pipework 水分配管道要求 7. Operational considerations 运行时的考虑 7.1 Start-up and commissioning of water systems 水系统开机和运行 7.2 Qualification 确认 7.3 Continuous system monitoring 对系统的持续监控 7.4 Maintenance of water systems 水系统维护 7.5 System reviews 系统回顾 8. Inspection of water systems 水系统检查 Further reading 扩展阅读 ©World Health Organization WHO Technical Report Series, No. 970, 2012 Annex 2 附件2 Page 2 of 20 1. Introduction 介绍 1.1 Scope of the document 文件范围 1.1.1 The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for