WHO《制药用水GMP指南》中英文该指南英文全文29页，包含以下内容： 饮用水、纯化水、高纯水、注射用水和其他级别的水的质量标准要求延续性
水系统良好规范
系统消毒与生物污染控制
储罐的要求
分配系统的要求
生物污染控制技术
第一阶段、第二阶段、第三阶段的操作考虑点
持续监测的要求
水系统的维护要求
系统回顾
水系统的检查
部分翻译如下：
1.Introduction
介绍
2.Background to waterrequirements and uses
水的要求和用途背景
3.General principles forpharmaceutical water systems
制药用水系统的一般原则
4.Water quality specifications
水的质量标准
4.1. Pharmacopoeial specifications
4.1.药典标准
4.2. Drinking-water
4.2.饮用水
4.3. Bulk purified water
4.3.纯化水
4.4. Bulk highly purified water
4.4.高纯水
4.5. Bulk water for injections
4.5.注射用水
4.6. Other grades of water
4.6.其他级别的水
5.General considerations forwater purification systems
水净化系统的一般考虑点
6.Water storage and distributionsystems
储存和分配系统
7.Good practices for watersystems
水系统良好规范
8.System sanitization and bioburdencontrol
系统消毒与生物污染控制
9.Storage vessels
储罐
10.Water distribution
分配系统
11.Biocontamination control techniques
生物污染控制技术
12.Operational considerations
操作的考虑点
12.5 Phase1
第一阶段
12.6 Phase2
第二阶段
12.7 Phase3
第三阶段
13.Continuous system monitoring
持续系统监测
14.Maintenance of water systems
水系统的维护
15.System reviews
系统回顾
16.Inspection of water systems
水系统的检查
17.References
参考资料
18.Further reading
延伸阅读
1 Introduction and scope
介绍及范围
1.1 Thisdocument concerns water for pharmaceutical use (WPU) produced, stored anddistributed in bulk form. It intends to provide informationabout different specifications for WPU; guidance on GMP regarding the qualitymanagement of water systems; water treatment (production) systems; waterstorage and distribution systems; qualification and validation; and sampling,testing and the routine monitoring of water.
本文件包括制药用水（WPU）的生产、储存和分配。本文件提供不同制药用水标准、水系统质量管理的GMP指南、水处理(生产)系统、制药用水储存和分配系统、确认和验证、以及取样、测试和水的日常监测相关的信息。
1.2 Althoughdrinking-water is addressed, the focus of this document is on the treatment,storage and distribution of treated water used in pharmaceutical applications.
虽然提到了饮用水，但本文件的重点是经处理的制药用水的处理、储存和分配。
1.3 Thisdocument does not cover water for administration to patients in the formulatedstate or the use of small quantities of water in pharmacies to compoundindividually prescribed medicines.2012新课标理综
本文件不包括处于配方状态的供病人使用的水，或在药房少量使用于配制个别处方药物的水。 1.4 Thedocument can be used in whole or in part, as appropriate, to the section andapplication under consideration.
本文件可全部或部分(视乎情况而定)用于审议中的部分和申请。
1.5 Inaddition to this document, the “Further reading” section at the end of thisdocument includes some relevant publications that can serve as additionalbackground material when planning, installing and using systems intended toprovide WPU.
除本文件外，本文件末尾的”延伸阅读”部分还包括一些相关出版物，在计划、安装和使用制药用水系统时可作为补充背景材料。
1.6 Thisdocument is supplementary to the World Health Organization (WHO) Goodmanufacturing practices for active pharmaceutical ingredients (2), and WHO Goodmanufacturing practices for pharmaceutical products: main principles (3).
本文件是对世界卫生组织(WHO)活物成分GMP(2)和WHO药物成品GMP(3)的补充。
2. Backgroundto water requirements and uses
水的要求和使用背景
2.1 Wateris a widely used substance in the pharmaceutical industry. It is extensivelyused as a raw material or starting material in the production, processing andformulation of active pharmaceutical ingredients (APIs), intermediates andfinished pharmaceutical products (FPP), in the preparation of solvents andreagents, and for cleaning (e.g. washing and rinsing). Water has uniquechemical properties due to its polarity and hydrogen bonds. It is able todissolve, absorb, adsorb or suspend different compounds. These would includecontaminants that may represent hazards in themselves or that may be able toreact with intended product substances, resulting in hazards to health. Watershould therefore meet the required quality standards to mitigate these risks.
比较优势理论>雷切尔薇姿
水是制药工业中广泛使用的物质。它被广泛用作活物成分（API）、中间体和成品（FPP）的生产、加工和配方的原料或起始材料，用于溶剂和试剂的制备，以及用于清洁（如清洗和冲洗）。水由于其极性和氢键，具有独特的化学性质。它能够溶解、吸收、吸附或悬浮不同的化合物。这可能包括本身构成危害或可能与预期产品物质发生反应的污染物，从而对健康造成危害。因此，水应符合必要的质量标准，以减轻这些风险。
2.2 Themicrobiological and chemical quality of water should be controlled throughoutthe
production, storage and distribution of water. Water is not usuallysubjected to testing and batch or lot release before use. It is usually drawnfrom a system on-demand for use. Results from testing arenormally available only after water has already been used as microbiologicaltests may require periods of incubation. The assurance of quality to meet theon-demand expectation of water is therefore essential.
在水的生产、贮存及分配过程中，应控制水的微生物及化学质量。水在使用之前通常不会经过测试和批放行。它通常来自一个按需使用的系统。由于微生物测试可能需要一段培养期时间，因此一般只有在用水后才可取得测试结果。因此，保证水的质量以满足用水需求是至关重要的。
2.3 Toreduce the risks associated with the production, storage and distribution ofwater and, conside
ring the properties and use of water, it is essential:
为了减少与水的生产、储存和分配有关的风险，并考虑到水的特性和用途，必须:
to ensure the appropriate design, installation, operation andmaintenance of the pre-treatment (production of drinking-water), treatment(production of WPU such as purified water (PW) and WFI), and storage anddistribution systems;
确保预处理(饮用水的生产)、处理(制药用水的制备，如下纯化水(PW)和注射用水(WFI))及贮存和分配系统得到适当的设计、安装、操作和维修;
to perform periodic sanitization;
定期进行卫生处理;
to take the appropriate measures in order to prevent chemical andmicrobial contamination; and
采取适当措施，防止化学和微生物污染；以及
to prevent microbial proliferation.
防止微生物繁殖。
2.4 Differentgrades of water quality exist. The appropriate water quality, meeting itsdefined specification, should be used for the intended application.
水的质量存在不同级别。应使用适当的水质（符合其既定标准）用于其预期目的。
3. Generalprinciples for pharmaceutical water systems
制药用水系统的一般原则
3.1 Pharmaceuticalwater production, storage and distribution systems should be designed,installed, commissioned, qualified, validated, operated and maintained toensure the consistent and reliable production of water of intended quality.
制药用水的生产、储存和分配系统应该设计、安装、调试、确认、验证、运行和维护，以确保一致和可靠地生产符合预期质量的水。
3.2 Thecapacity of these systems should be appropriate to meet the average and peakflow demand. The systems should be able to operate continuously for significantperiods of time in order to avoid the inefficiencies and equipment stressesthat occur when equipment
cycles turn on and off too frequently.
系统的能力应适当，以满足平均流量和峰值流量的需求。系统应能够连续长时间运行，以避免因设备频繁开启和关闭而造成的效率低下和设备压力。
3.3 Theuse of the systems following an initial qualification such as installationqualification (IQ), operational qualification (OQ), performance qualification(PQ) and validation should be approved by the quality unit, e.g. qualityassurance (QA).
在初始确认(例如安装确认、运行确认、性能确认和验证)后，系统的使用应由质量部门批准，例如质量保证(QA)。
3.4 Watersources and treated water should be monitored regularly for chemical,microbiological and, as appropriate, endotoxin contamination. The performanceof water treatment, storage and distribution systems should also be monitored.Records of the results monitored, trend analysis and any actions taken shouldbe maintained.
教学一得应定期监测原水及处理后水的化学、微生物及(如适用)内毒素污染情况。水的处理、储存和分配系统的性能也应监测。应保存监测结果，趋势分析，以及任何所采取行动的记录。
4. Water quality specifications
水的质量标准
4.1 Pharmacopoeialspecifications
药典标准
4.1.1 Pharmacopoeiasinclude specifications for both bulk and dosage form types of water. Where thisdocument refers to specifications, such as the pharmacopoeias, the relevant,current publications should be used. This document does not attempt to duplicatesuch material. Where subtle points of difference exist between pharmacopoeialspecifications, the manufacturer should choose the appropriate specification inaccordance with the related marketing authorization submitted to the relevantmedicine’s regulatory authority. Pharmacopoeial requirements or guidance forWPU are described in national, regional and international pharmacopoeias (4)and limits for various impurities or classes of impurities are either specifiedor recommended. Requirements or guidance are given in pharmacopoeias on themicrobiological quality of water.
药典包括水的使用和制剂标准。本文件所提及标准，例如药典，则应使用相关的最新版本。本文件将
不重复这些内容。如不同药典标准之间存在细微差别，制造商应根据向相关药监机构提交的上市许可来选择的适当的标准。国家、地区和国际药典(4)对制药用水的药典要求或指南进行了描述，并规定或推荐了各种杂质或杂质类别的限值。药典对水的微生物质量提出了要求或指导。
4.2 Drinking-water
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