修订内容:描述水的质量标准时,引用了药典 2.4 Different grades of water quality exist. The appropriate water quality, meeting its defined specification(such as described in a pharmacopoeia), should be used for the intended application. 存在有不同级别的水质。应...
The appropriate water quality, meeting its defined specification (such as described in a pharmacopoeia), should be used for the intended application.存在有不同级别的水质。应根据目标用途使用符合指定质量标准的水,如参考药典的要求。 新增内容 2.5 The application of specific types of water to processes ...
2.4 Different grades of water quality exist. The appropriate water quality, meeting its defined specification (such as described in a pharmacopoeia), should be used for the intended application. 存在有不同级别的水质。应根据目标用途使用符合指定质量标准的水,如参考药典的要求。 新增内容 2.5 The applica...
修订内容:描述水的质量标准时,引用了药典 2.4 Different grades of water quality exist. The appropriate water quality, meeting its defined specification(such as described in a pharmacopoeia), should be used for the intended application. 存在有不同级别的水质。应根据目标用途使用符合指定质量标准的水,如参...
Thus it is essential that water quality (including microbiological and chemical quality) throughout production, storage and distribution processes is controlled. 与其他产品或工艺成分不同,水通常 是 从按需 制备 的 系统提取, 且 在使用前不受 检测 和 批放行 限制 。因此,对从 生产、储存和分配 全 ...
3.4 Highly purified water 高纯水 Highly purified water (HPW) should be prepared from potable water as a minimum-quality feed-water. HPW is a unique specification for water found only in the European Pharmacopoeia . This grade of water must meet the same quality standard as water for injections...
PRODUCTION OF WATER FOR INJECTION BY MEANS OTHER THAN DISTILLATION 采用非蒸馏方法制备注射用水 1. INTRODUCTION 前言 略 2. SCOPE 范围 略 3. MONOGRAPHS 各论 3.1. Manufacturers should have aspecification for WFI. 生产商应具备WFI的质量标准。
WHOGoodManufacturingPractices:waterforpharmaceuticaluseWHO良好的生产实践(GMP):制药用水篇 1.Introduction简介 1.1Scopeofthedocument文件范畴 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 ...
4.2. Stages in the life cycle in production include, but are not limited to, the collection and treatment of source water, treatment of potable water used in production of WFI, production of WFI, storage, distribution and use of WFI. 制备的生命周期各阶段包括但不仅限于采集和处理源水、处理WF...
4.2. Stages in the life cycle in production include, but are not limited to, the collection and treatment of source water, treatment of potable water used in production of WFI, production of WFI, storage, distribution and use of WFI. ...