1.1 Thisdocument concerns water for pharmaceutical use (WPU) produced, stored anddistributed in bulk form. It intends to provide informationabout different specifications for WPU; guidance on GMP regarding the qualitymanagement of water systems;water treatment(production) systems; waterstorage and distribu...
1.1 Thisdocument concerns water for pharmaceutical use (WPU) produced, stored anddistributed in bulk form. It intends to provide informationabout different specifications for WPU; guidance on GMP regarding the qualitymanagement of water systems; water treatment (production) systems; waterstorage and dist...
It provides information on different specifications for WPU; good practices for the management of the quality of water systems; water treatment (production) systems; water storage and distribution systems; commissioning, qualification and validation; sampling and testing; and the routine monitoring of wat...
Backgroundtowaterrequirementsanduses 水的要求和用途背景 Generalprinciplesforpharmaceuticalwatersystems 制药用水系统的一般原则 Waterqualityspecifications 水的质量标准 Pharmacopoeialspecifications4.1.药典标准 Drinking-water4.2.饮用水 Bulkpurifiedwater4.3.纯化水 ...
WHO制药用水中英对照版
1.2Backgroundtowaterrequirementsanduses水质要求和使用背景 1.3Applicableguides应用指南 2.Generalrequirementsforpharmaceuticalwatersystems制药用水系统基本要求 3.Waterqualityspecifications水质规定 3.1General概要 3.2Drinking-water饮用水 3.3Purifiedwater纯水 3.4Highlypurifiedwater高纯水 ...
WHO《制药用水GMP指南》-2020草案(中英文对照版)Working document QAS/20.842 工作文件QAS/20.842 May 2020 二零二零年五月DRAFT WORKING DOCUMENT FOR COMMENTS:征求意见草案:Good manufacturing practices:优良制造规范（GMP）:water for pharmaceutical use 制药用水 1 / 25 ...
4.Water quality specifications 水的质量标准 4.1. Pharmacopoeial specifications 4.1.药典标准 4.2. Drinking-water 4.2.饮用水 4.3. Bulk purified water 4.3.纯化水 4.4. Bulk highly purified water 4.4.高纯水 4.5. Bulk water for injections 4.5.注射用水 4.6. Other grades of water 4.6.其他级别的水 5...
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...
4. Water quality specifications 水的质量标准 4.1. Pharmacopoeial specifications 药典标准 4.2. Drinking-water 饮用水 4.3. Bulk purified water 纯化水 4.4. Bulk highly purified water 高纯水 4.5. Bulk water for injections 注射用水 4.6. Other grades of water ...