1. Introduction and scope概述与范围
1.1 This document concerns water for pharmaceutical use (WPU) produced stored and distributed in bulk form. It intends to provide information about different specifications for WPU; guidanceon GMP regarding the quality management of water systems; water treatment (production) systems; water storage and distribution systems; qualification and validation; and sampling, testing and the routine monitoring of water.
本文涉及的是以散装形式存贮和分配的制药用水（WPU）。其目的是提供关于WPU的不同标准信息、水系统质量管理方面的GMP指南、水处理（制备）系统、水存贮和分配系统、确认和验证，以及水的取样、检测和常规监测。
1.2 Although drinking-water is addressed, the focus of this document is on the treatment, storage and distribution of treated water used in pharmaceutical applications.
虽然也提到了饮用水，但本文件的关注点在于水的处理以及准备用于制药用途的处理后的水的存贮和分配。
1.3 This document does not cover water for administration to patients in the formulated state or the use of smallquantities of water in pharmacies to compound individually prescribed medicines.
本文不包括已配制好供患者摄入的水，和药房配制个人处方药时所用的少量的水。
1.4 The document can be used in whole or in part, as appropriate, to the section and application under consideration.
本文可整体使用，亦可根据考量部分使用和应用（适当时）。
1.5 In addition to this document, the “Further reading” section at the end of this document includes some relevant publications that can serve as additional background material when planning, installing and using systems intended to provide WPU.
除本文外，本文结尾“延伸阅读”部分还包括有一些相关出版物，可作为WPU供水系统规划、安装和使用的额外背景资料使用。
1.6 This document is supplementary to the World Health Organization (WHO) Good manufacturing practices for active pharmaceutical ingredients (2), and WHO Good manufacturing practices for pharmaceutical products: main principles (3).
本文件是WHO“原料药GMP”和WHO“药品GMP：主则”的补充。
2. Background to water requirements and uses水的需求与使用背景
2.1 Water is a widely used substance in the pharmaceutical industry. It is extensively used as a raw material or starting material in the production, processing and formulation of active pharmaceutical ingredients (APIs), intermediates and finished pharmaceutical products (FPP), in the preparation of solvents and reagents, and for cleaning (e.g. washing and rinsing). Water has unique chemical properties due to its polarity and hydrogen bonds. It is able to dissolve, absorb, adsorb or suspend different compounds. These would include contaminants that may represent hazards in themselves or that may be able to react with intended product substances, resulting in hazards to health. Water should therefore meet the required quality standards to mitigate these risks.
水是制药行业中被广泛使用的一种物质。它在活性药用成分（API）、中间体和制剂（FPP）生产、加工和配方中被广泛用作原料或起始物料，还被用于制备溶剂和试剂，以及用于清洁。水因其极性和氢键的原因，具有独特的化学特性，它可以溶解、吸收、吸附或悬浮不同物质。这其中就包括本身可能有害的污染物，或是可与目标产品物质发生反应的物质，从而导致对健康的危害。因此水需要符合所需的质量标准，从而降低这些风险。
2.2 The microbiological and chemical quality of water should be controlled throughout the production, storage and distribution of water. Water is not usually subjected to testing and batch or lot release before use. It is usually drawn from a system on-demand for use. Results from testing are normally available only after water has already been used as microbiological tests may require periods of incubation. The assurance of quality to meet the on-demand expectation of water is therefore essential.
在水的制备、存贮和分配过程中，应对水的微生物和化学质量进行控制。水在使用之前通常不会进行检测，不会进行批放行。它通常是来自按需制备系统。检测结果通常只有在水已经被使用之后才能取得，因为微生物测试可能会需要一段时间来培养。因此保证水的质量符合所需要求是至关重要的。
2.3 To reduce the risks associated with the production, storage and distribution of water and, considering the properties and use of water, it is essential:
为降低水的制备、存贮和分配有关的风险，同时考虑水的特性用途，以下方面非常重要：
• to ensure the appropriate design, installation, operation and maintenance of the pre- treatment (production of drinking-water), treatment (production of WPU such as purified water (PW) and WFI), and storage and distribution systems;
•确保预处理（饮用水制备）、处理（WPU如纯化水（PW）和WFI的制备），和存贮与分配系统有恰当的设计、安装、运行和维护
• to perform periodic sanitization;
•定期消毒
• to take the appropriate measures in order to prevent chemical and microbial contamination; and
•采取恰当措施防止化学和微生物污染
• to prevent microbial proliferation.
•防止微生物激增
2.4 Different grades of water quality exist. The appropriate water quality, meeting its defined specification, should be usedfor 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。
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