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
3.3.1 Bulk purified water (BPW) should be prepared from a drinking-water source as a minimum-quality feed-water. It should meet the relevant pharmacopoeial specifications for chemical and microbiological purity with appropriate action and alert limits. It should also be protected from recontamination and microbial proliferation. BPW may be prepared by a
combination of reverse osmosis (RO) RO/electro-deionization (EDI) and vapour compression (VC). Alert levels for the water system should be determined from knowledge of the system and are not specified in the pharmacopoeias.
散装纯化水（BPW）应采用饮用水源作为最低质量源水来制备。它应该符合相关的药典质量标准中化学和微生物纯度，并制订有适当的行动和警戒限。它还应该保护不受再次污染和微生物滋生。BPW可以采用RO，RO/EDI和蒸汽压缩方式制备。水系统的警戒限应从对系统的了解来制订，在药典中并未指定。 3.4 Bulk highly purified water 散装高纯水
3.4.1 Bulk highly purified water (BHPW) should be prepared from drinking water as a
minimum-quality feed-water. BHPW 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 (WFI), including the limit for endotoxins, but the water-treatment process used may be different. Current production methods include, for example, double-pass RO coupled with other suitable techniques such as ultrafiltration and deionization.
散装高纯水（BHPW）源水最低应为饮用水。BHPW质量标准仅在欧洲药典中提出。该级别水必须符合注射用水（WFI）相同的质量标准，包括内毒素限度，但制水工艺可以是不同的。目前的制水方法包括，例如，两次反渗透配合其它适当的技术，如超滤和去离子。 BHPW may be prepared by a combination of different methods such as RO, ultrafiltration and deionization.
BHPW可能需要采用不同方法联合制备，如RO、超滤和去离子。
3.4.2 BHPW should also be protected from recontamination and microbial proliferation. BHPW也需要保护不受再污染和微生物滋生。
3.4.3 BHPW and WFI have identical microbiological requirements. BHPW和WFI有相同的微生物要求。 3.5 Bulk water for injections 注册用散装水
3.5.1 Bulk water for injections (BWFI) should be prepared from drinking-water (usually with further treatment) or purified water as a minimum-quality feedwater. BWFI is not sterile water and is not a final dosage form. It is an intermediate bulk product and suitable to be used as an ingredient during formulation. BWFI is the highest quality of pharmacopoeial WPU.
散装注射用水（BWFI）应采用饮用水（一般会进一步处理）或纯化水作为最低原水质量来制备。BWFI不是无菌水，不是最终的剂型。它是一个中间散装产品，可以在配方中作为一种成分加入。BWFI是药典WPU中质量最高的水。
3.5.2 Certain pharmacopoeias place constraints upon the permitted purification techniques as part of the specification of the BWFI. The International Pharmacopoeia and the European Pharmacopoeia, for example, allow only distillation as the final purification step.
某些药典对纯化方法作为BWFI质量标准的一部分进行了限制。国际药典和欧洲药典，例如，仅允许将蒸馏作为最终纯化步骤。
3.5.3 BWFI should meet the relevant pharmacopoeial specifications for chemical and microbiological purity (including endotoxin) with appropriate action and alert limits.
BWFI应符合相关的药典质量标准中化学和微生物纯度（包括内毒素），并制订有适当的行动限和警戒限。
3.5.4 BWFI should also be protected from recontamination and microbial proliferation. BWFI还应保持免受再污染和微生物滋生。 3.6 Other grades of water 其它级别水
3.6.1 When a specific process requires a special non-pharmacopoeial grade of water, its
specification must be documented within the company quality system. As a minimum it must meet the pharmacopoeial requirements relating to the grade of WPU required for the type of dosage form or process step.
如果特定的工艺要求特殊的非药典级别水，其质量标准必须记录在公司的质量体系中。水的质量至少必须满足该类型剂型或工艺步骤的WPU级别相关的药典要求.
4. Application of specific types of water to processes and dosage forms 特定类型的水在工艺和剂型中的用途
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