WHO水系统 GWCZ-2016-008_中英文

WHO 970号技术报告 附件2 制药用水 2012

Annex 2 附件2

WHO good manufacturing practices: water for pharmaceutical use[1] 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 深入阅读

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 specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on good manufacturing practices (GMP) regarding the design, installation and operation of pharmaceutical water systems. Although the focus of this document is on water for pharmaceutical applications, the guidelines may also be relevant to other industrial or specific uses where the specifications and practices can be applied. 本文件中包括的本指南目的在于提供以下信息，关于制药用水的可获得的质量标准，哪种质量的水适用于特定用途，例如活性药用物质（API）生产和制剂生产，提供关于药用水系统设计、安装和运行GMP指南。尽管本文重点在于药用水，如果适用相同的质量标准和规范的话，指南可能也与其它行业或特定用途相关。

Note: This document does not cover water for administration to patients in the formulated state or the use of small quantities of water in pharmacies to compound individually prescribed medicines. 注：本文件未包括在配方状态下给病人摄入的水，和少量用于药房单独处方配制的水。

1.1.2 The GMP guidance for WPU contained in this document is intended to be supplementary to the general GMP guidelines for pharmaceutical products published by WHO (WHO Expert Committee on Specifications for Pharmaceutical Preparations. thirty-seventh report. Geneva, World Health Organization, 2003 (WHO Technical Report Series, No. 908), Annex 4).

本文件中对WPU的GMP指南是对WHO出版的通用药物GMP指南（WHO专家委员会：制剂质量标准，第37号报告，日内瓦，WHO，2003（WHO技术报告系列第908号）附件4）的补充。

1.1.3 This document refers to available specifications, such as the pharmacopoeias and industry guidance for the use, production, storage and distribution of water in bulk form. In order to avoid confusion it does not attempt to duplicate such material.

本文件引用了可以得到的质量标准，例如药典，和行业中对散装形式水的使用、制备、存贮和分配的指南。为避免混淆，这里没有复制这些内容。

1.1.4 The guidance provided in this document can be used in whole or in part as appropriate to the application under consideration.

在本文件中给出的指南可以，适用时，全部或部分用于讨论下的用途。

1.1.5 Where subtle points of difference exist between pharmacopoeial specifications, the manufacturer will be expected to decide which option to choose in accordance with the related marketing authorization submitted to the national medicines regulatory authority.

如果在不同药典质量标准间存在很小的差异，生产商应根据其将要提交上市许可的相关的市场的药监当局来决定其选择。

1.2 Background to water requirements and uses 水的要求和使用的背景

1.2.1 Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. It has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb or suspend many different compounds. These include contaminants that may represent hazards in themselves or that may be able to react with intended product substances, resulting in hazards to health.

水是药品生产、处理和配方中最广泛使用的物质、原料或起始物料。由于其极性和氢键，它具有独一无二的化学特性。这表示它可能溶解、吸收、或吸附许多不同的化合物。这也包括可能会出现的对其自身产生危害的污染物，或可能与想要的产品物质发生反应，对健康产生危害。

1.2.2 Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern.

在制备、存贮和分析过程整个过程中，对水的质量的控制，包括微生物和化学质量，是主要的关注点。

Unlike other product and process ingredients, water is usually drawn from a system on demand, and is not subject to testing and batch or lot release before use. Assurance of quality to meet the on-demand expectation is, therefore, essential. Additionally, certain microbiological tests may require periods of incubation and, therefore, the results are likely to lag behind the water use. 不象其它产品和工艺成分，水一般根据需求从系统中抽出，在使用前不会经过检测和批放行。因此，必须保证其质量符合预期的要求。另外，由于某些微生物检测会需要一定的培养周期，因此，其结果可能会在水使用之后才出来。

1.2.3 Control of the microbiological quality of WPU is a high priority. Some types of

microorganism may proliferate in water treatment components and in the storage and distribution systems. It is crucial to minimize microbial contamination by proper design of the system, periodic sanitization and by taking appropriate measures to prevent microbial proliferation.

对WPU的微生物质量控制是第一位的。一些类型的微生物可能会在水处理元件和存贮分配系统中滋生。通过适当的系统设计、周期消毒、采取适当措施防止微生物滋生来降低微生物污染是很关键的。

1.2.4 Different grades of water quality are required depending on the route of administration of the pharmaceutical products. Other sources of guidance about different grades of water can be found in pharmacopoeias and related documents.

对不同级别的水的质量的要求取决于药品的给药方式。其它关于不同级别水的指南可以在药典和相关文件中找到。

1.3 Applicable guides 适用的指南

1.3.1 In addition to the specific guidance provided in this document, the Further reading section includes some relevant publications that can serve as additional background material when planning, installing and using systems intended to provide WPU.

除了在本文中提供的特定的指南外，扩展阅读包括一些相关的出版物，可以在计划、安装和使用WPU用途系统时，作为额外的背景材料。

2. General principles for pharmaceutical water systems 制药用水系统的一般原则

2.1 Pharmaceutical water production, storage and distribution systems should be designed, installed, commissioned, qualified and maintained to ensure the reliable production of water of an appropriate quality. It is necessary to validate the water production process to ensure the water generated, stored and distributed is not beyond the designed capacity and meets its specifications.

药用水的制备、存贮和分配系统的设计、安装、调试、确认和维护应保证可靠的产水，适当的质量。需要对水的制备过程进行验证，以保证水的制备、存贮和分配不超过设计的产能，并符合其质量标准。

2.2 The capacity of the system should be designed to meet the average and the peak flow demand of the current operation. If necessary, depending on planned future demands, the system should be designed to permit increases in the capacity or designed to permit modification. All systems,

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