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...
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...
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 ...
2.Background to waterrequirements and uses水的要求和用途背景 3.General principles forpharmaceutical water systems制药用水系统的一般原则 4.Water quality specifications水的质量标准 4.1.Pharmacopoeial specifications 4.1.药典标准 4.2.Drinking-water4.2.饮用水 4.3.Bulk purified water4.3.纯化水 4.4....
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...
Water should therefore meet a ppropriate quality standards to mitigate these risks. 水是药品 和其他制药 相关 产品广泛使用的物质。它广泛用于原料药 (APIs) 、中间体和成品(FPP) 的产品、工艺 和配方 中作为 原料或起始物料 、 溶剂试剂的制备以及清洗 清洁 。水由于其极性和氢键而具有独特的化学性质 ,...
Goodmanufacturingpractices:waterforpharmaceuticaluse 优良生产规范(GMP):制药用水 Background背景 Thecontrolofwaterquality,includingmicrobiologicalandchemicalquality,throughoutproduction,storageand distributionprocessesisamajorconcern.Unlikeotherproductandprocessingredients,waterisusuallydrawn fromanon-demandsystemandisnotsubje...
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 ...
2. Background to water requirements anduses 水的要求和用途背景 3. General principles forpharmaceutical water systems 制药用水系统的一般原则 4. Water quality specifications 水的质量标准 4.1. Pharmacopoeial specifications 药典标准 4.2. Drinking-water ...
Rev/1:Revisionsindicatedwithaverticallineintheleftmargin.WHO/SDE/WSH/03.04/104/Rev/1ManganeseinDrinking-waterBackgrounddocumentfordevelopmentofWHOGuidelinesforDrinking-waterQualityManganeseinDrinking-waterBackgrounddocumentfordevelopmentofWHOGuidelinesforDrinking-waterQuality©WorldHealthOrganization2011Allrightsreserved...