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,
regardless of their size and capacity, should have appropriate recirculation and turnover to assure system is well controlled chemically and microbiologically.
系统的产能设计应能满足目前运行的平均用水量，和高峰用水量。必要时，依赖于计划的未来的需求，系统设计应使得产能增加成为可能，或设计为可以进行改造的情形。所有系统，不管其尺寸和产能如何，均应具有适当的循环和产出，以保证能很好地控制系统的化学和微生物污染。
2.3 The use of the systems following initial validation (installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)) and after any planned and unplanned maintenance or modification work should be approved by the quality assurance (QA) department using change control documentation.
在进行了初始验证（安装确认（IQ）、运行确认（OQ）和性能确认（PQ）之后，在进行了任何计划内和计划外的维护或改造之后，对系统的使用均应经过QA部门通过变更控制文件进行批准。
2.4 Water sources and treated water should be monitored regularly for chemical, microbiological and, as appropriate, endotoxin contamination. The performance of water purification, storage and distribution systems should also be monitored. Records of the monitoring results, trend analysis and any actions taken should be maintained.
水源和处理过的水均应定期监控化学、微生物和，适当时，内毒素污染。水纯化、存贮和分配系统的性能也需要进行监控。监控结果、趋势分析和所有采取的措施的记录均应保存。 2.5 Where chemical sanitization of the water systems is part of the biocontamination control programme a validated procedure should be followed to ensure that the sanitizing process has been effective and that the sanitizing agent has been effectively removed.
如果水系统的化学消毒是生物污染控制计划的一部分，则应制订一份验证程序，以保证消毒过程有效，消毒剂被有效清除。
3. Water quality specifications 水的质量标准 3.1 General 概述
3.1.1 The following requirements concern water processed, stored and distributed in bulk form. They do not cover the specification of water formulated for patient administration. Pharmacopoeias include specifications for both bulk and dosage form types of water.
以下要求是关于散装水的处理、存贮和分配。不包括用于治疗的配方用水的质量标准。药典包括散装和剂型用水两种质量标准。
3.1.2 Pharmacopoeial requirements or guidance for WPU are described in national, regional and international pharmacopoeias and limits for various impurities or classes of impurities are either specified or recommended.
药典要求或指南对WPU的要求在国家、地区和国际药典中进行了描述，其中设定了不同杂质的限度，或对杂质各类进行了指定或推荐。
Companies wishing to supply multiple markets should set specifications that meet the strictest requirements from each of the relevant pharmacopoeias. Similarly, requirements or guidance are given in pharmacopoeias on the microbiological quality of water.
希望在多个市场上市的公司应设定标准以满足相关药典中最严格的要求。类似的，药典中给出了水的微生物质量的要求或指南。 3.2 Drinking-water 饮用水
3.2.1 Drinking-water should be supplied under continuous positive pressure in a plumbing system free of any defects that could lead to contamination of any product.
饮用水应以持续正压方式，通过卫生管道系统供应，不应有缺陷导致任何产品的污染。 3.2.2 Drinking-water is unmodified except for limited treatment of the water derived from a natural or stored source. Examples of natural sources include springs, wells, rivers, lakes and the sea. The condition of the source water will dictate the treatment required to render it safe for human consumption (drinking).
饮用水是没有经过处理的水，除了对自然或蓄水产生的水进行有限的处理外。自然水源的例子包括喷泉、井水、河水、湖水和海水。源水条件会决定所需的处理，以保证人们消耗（饮用）的安全。
Typical treatment includes desalinization, softening, removal of specific ions, particle reduction and antimicrobial treatment.
典型的处理包括除盐、软化、除去特定的离子、减少颗粒和抗微生物处理。
3.2.3 It is common for drinking-water to be derived from a public water supply that may be a combination of more than one of the natural sources listed above. It may also be supplied either
an offsite source, e.g. a municipality, or appropriate quality may be achieved onsite through appropriate processing.
比较常见的，是饮用水从公共供水系统中产生，这可能是上面列出的自然来源的不止一种的合并情况。它还可能是从场所外来源供应，例如，市政当局，或可能通过在工厂内进行适当处理来获得适当的质量。
3.2.4 It is also common for public water supply organizations to conduct tests and guarantee that the drinking-water delivered is of drinking quality. This testing is typically performed on water from the water source.
另外比较常见的，是公共的水供应组织进行测试，保证输送的饮用水具有饮用品质。这些测试一般是在水源处进行。
3.2.5 It is the responsibility of the pharmaceutical manufacturer to assure that the source water supplying the purified water (PW) treatment system meets the appropriate drinking-water requirements. There may be situations where the water treatment system is used first to achieve drinking-water quality and subsequently purified water. In these situations the point at which drinking-water quality is achieved should be identified and tested.
药物生产商有责任保证供应纯化水(PW)处理系统的源水符合适当的饮用水要求。可能会采用水处理系统使得水质先达到饮用水品质，之后再达到纯化水品质。这种情况下，达到饮用水品质的点应该被识别，此处的水质应进行检测。
3.2.6 Drinking-water quality is covered by the WHO drinking-water guidelines, standards from the International Organization for Standardization (ISO) and other regional and national agencies. Drinking-water should comply with the relevant regulations laid down by the competent authority. 饮用水质量已包括在WHO饮用水指南，ISO和其它地区和国家机构的标准中。饱用水应符合由适当的当局设定的相关法规的要求。
3.2.7 If drinking-water is used directly in certain stages of pharmaceutical manufacture or is the feed-water for the production of higher qualities of WPU, then testing should be carried out periodically by the water user’s site to confirm that the quality meets the standards required for drinking-water.
如果采用饮用水直接用于药品生产某些步骤，或采用饮用水作为源水用于高品质的WPU的生产，则应在水的使用场所对水进行周期检测，以确认其质量符合要求的饮用水标准。 3.3 Bulk purified water 散装纯化水
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