WHO发布《制药用水GMP指南》--【西安华道安创】

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WHO发布《制药用水GMP指南》

文章来源：GMP办公室编辑：西安华道安创

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.

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)活性药物成分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.

水是制药工业中广泛使用的物质。它被广泛用作活性药物成分（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, considering 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.

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

饮用水

4.2.1 Thequality of drinking-water is covered by the WHO drinking-water qualityguidelines (5) and standards from the International Organization forStandardization (ISO) and other regional and national agencies. Drinking-watershould comply with the relevant regulations laid down by the competentauthority.

饮用水的质量由WHO饮用水质量指南(5)和国际标准化组织卫生组织(ISO)及其他区域和国家机构的标准所涵盖。饮用水应当符合主管机构的有关规定。

4.2.2 Drinking-watermay be derived from a natural or stored source. Examples of natural sourcesinclude springs, wells, rivers, lakes and the sea. The condition of the sourcewater should be considered when choosing a treatment to produce drinking-water. A typical treatment would include desalinization, softening, removal ofspecific ions, particle reduction and antimicrobialtreatment.

饮用水可来自天然或储存的水源。自然资源的例子包括泉水、井水、河流、湖泊和海洋。在选择饮用水处理方法时，应考虑水源水的条件。典型的处理方法包括脱盐、软化、特定离子的去除、颗粒降低和抗菌处理。

4.2.3 Drinking-watershould be supplied under continuous positive pressure by a plumbing system freeof any defects that could lead to contamination of any product.

饮用水应由管道系统在持续正压下供应，不得有任何可能污染任何产品的缺陷。

4.2.4 Drinking-watermay be derived from a public water supply system. This includes an off-sitesource, such as a municipality. The appropriate drinking-water quality shouldbe ensured by the supplier. Tests should be conducted to guarantee that thedrinking-water delivered is of drinking quality. This testing is typicallyperformed on water from the water source. Where required, the quality may beachieved through appropriate processing on-site.

饮用水可能来自公共供水系统。这包括一个工厂外的来源，比如市政当局。供应商应确保适当的饮用水水质。应当进行检验，以保证所提供的饮用水的质量。这种测试通常在原水供应点进行。必要时，应进行适当的内部处理以达到规定质量。

4.2.5 Wheredrinking-water is purchased in bulk and transported to the user by watertanker, controls should be put in place to mitigate any risks associatedtherewith. Vendor assessment and authorized certification activities, includingconfirmation of the acceptability of the delivery vehicle, should be undertakenin a way similar to that used for any other starting material.

如果饮用水是散装购买，并由水罐车运送给用户，应进行控制以减少与此相关的任何风险。供应商评估和批准认证活动，包括确认运载工具的可接受性，应以类似于任何其他起始物料的方式进行。

4.2.6 Itis the responsibility of the pharmaceutical manufacturer to assure that thesource water supplying the PW treatment system meets the appropriatedrinking-water requirements. In these situations, the point at whichdrinking-water quality is achieved should be identified and a water sampletaken and tested at defined intervals thereafter.

药品制造商有责任确保供应纯化水处理系统的源水符合适当的饮用水要求。在这些情况下，应确认达到饮用水质量的点，并在其后以规定的时间间隔取样和测试。

4.2.7 Ifdrinking-water is used directly in certain stages of pharmaceuticalmanufacture, such as in the production of APIs or in the feedwater for theproduction of higher qualities of WPU, then testing should be carried outperiodically by the water user’s site to confirm that the quality meets thestandards required for drinking-water.

如果在药物制造的某些阶段直接使用饮用水，例如在原料药生产或在生产较高质量制药用水的给水中直接使用饮用水，工厂应定期进行测试，以确认水质符合饮用水所需的标准。

4.2.8 Wheredrinking-water is produced through the treatment of raw water by a systemon-site, the system configuration and water-treatment steps used should bedescribed.

如饮用水是由原水经现场系统处理而产生，则应说明系统配置及所采用的水的处理步骤。

4.2.9 Examplesof typical processes employed to produce drinking-water may include:

制备饮用水的典型工序例子包括:

desalinization;
脱盐;

filtration;
过滤;

softening;
软化;

disinfection or sanitization (e.g. by sodium hypochlorite {chlorine}injection);
消毒(例如使用次氯酸钠{氯});

iron (ferrous) removal;
除铁;

precipitation; and
沉降;以及

the reduction of concentration of specific inorganic and/or organicmaterials.
降低特定无机和/或有机物质的浓度。

4.2.10 Controls should be implemented toprevent the microbiological contamination of sand filters, carbon beds andwater softeners. The techniques selected should be appropriate and may includebackflushing, chemical and/or thermal sanitization and frequent regeneration.

应实施控制以防止砂滤器、碳床和水软化装置受微生物污染。所选择的技术应该是适当的，可以包括反冲洗、化学和/或热消毒以及频繁的再生。

4.2.11 The quality of drinking-water shouldbe monitored routinely to account for environmental, seasonal or supply changeswhich may have an impact on the source water quality.

应定期监测饮用水的水质，考虑可能影响源水水质的环境、季节或供应变化。

4.2.12 Where drinking-water is stored anddistributed by the user, the storage and distribution systems should not allowthe degradation of the water quality prior to use. After any such storage,testing should be carried out routinely and in accordance with a definedprocedure. The storage and distribution of drinking-water should be done in amanner to ensure a turnover or recirculation of the stored water sufficientenough to prevent stagnation.

当用户对饮用水进行储存和分配时，储存和分配系统不应在使用前降低水质。任何此类存储后，应进行日常测试，并符合既定程序。饮用水的储存和分配应以某种方式确保所储存水的翻滚或循环足以防止停滞。

4.2.13 The equipment and systems used toproduce and store drinking-water should be able to be drained and sanitized.

用于生产和储存饮用水的设备和系统应能够排水和消毒。

4.2.14 Storage tanks should be closed withappropriately protected vents and should allow for visual inspection.

储罐应密封，配以受适当保护的通气口，并应可以目视检查。

4.2.15 Distribution pipework should be ableto be drained or flushed and sanitized.

分配管道应该能够排水、冲洗和消毒。

4.2.16 The scope and extent ofqualification for the system should be identified and justified.

应确定和论证系统确认范围和程度。

4.2.17 The results from testingdrinking-water should be subjected to statistical analysis in order to identifytrends and changes. If the drinking-water quality changes significantly, but isstill within specification, the direct use of this water as a WPU, or as thefeedwater to downstream treatment stages, should be reviewed for any risks andthe results of the review and action to be taken and documented.

饮用水测试结果应作统计分析，以确定趋势和变化。如果饮用水水质发生重大变化，但仍符合标准，则应审查直接将这种水用作制药用水或作为下游处理阶段的给水，以审查任何风险以及审查的结果和采取的行动并记录。

4.2.18 Changes to a system or to itsoperation should be made in accordance with change control procedures.

系统或其操作的变更应按照变更控制程序进行。

4.2.19 Additional testing should be consideredif there is any change in the raw water source, treatment techniques or systemconfiguration.

如原水来源、处理技术或系统配置有任何变更，应考虑进行额外测试。

4.3 Bulkpurified water

纯化水

4.3.1 Bulkpurified water (BPW) should meet the relevant pharmacopoeial specifications forchemical and microbiological purity.

纯化水(BPW)应符合相关药典的化学和微生物标准。

4.3.2 BPWshould be prepared from drinking-water as a minimum-quality feedwater.

纯化水应最少由饮用水制备而成。

4.3.3 Anyappropriate, qualified purification technique, or sequence of techniques, maybe used to prepare BPW. BPW may be prepared by, for example, a combination ofion exchange, RO, RO/electro-deionization (EDI), ultrafiltration and vapourcompression.

可使用适当的、经确认的纯化技术或技术组合制备纯化水。纯化水可通过，例如，离子交换、反渗透、反渗透/电去离子(EDI)、超滤和蒸汽压缩的组合来制备。

4.3.4 Thefollowing should be considered when configuring a water purification system ordefining user requirement specifications (URS):

在配置纯化水系统或定义用户需求规范(URS)时，应考虑以下因素:

the quality of feedwater and its variation over seasons;
给水质量及其季节变化;

the quantity of water required by the user;
用户所需的用水量;

the required water-quality specification;
所需的水质标准;

the sequence of purification stages required;
所需的纯化阶段顺序;

energy consumption;
能耗;

appropriately located sampling points designed in such a way so asto avoid potential contamination; and
适当设置取样点，以避免潜在污染;以及
unit process steps provided and documented with the appropriateinstrumentation to measure parameters suchas flow, pressure, temperature, conductivity, pH and total organic carbon.
各单元处理步骤提供并记录适当的仪器，以测量诸如流量、压力、温度、电导率、pH值和总有机碳等参数。

4.3.5 Ambient-temperaturesystems such as ion exchange, RO and ultrafiltration are especially susceptibleto microbiological contamination, particularly when equipment is static duringperiods of no or low demand for water. Sanitization, at defined intervals, aswell as other controls, should be defined to prevent and minimizemicrobiological contamination.

离子交换、反渗透和超滤等环境温度系统特别容易受到微生物污染，尤其是当设备在没有或需水量很低处于停止的时候。为了防止和减少微生物污染，应该定期进行消毒处理以及其他控制措施。

4.3.6 Appropriate,validated methods for sanitizing each stage of purification needs to be inplace. Where agents are used for sanitization, their removal must be proven.

每个纯化阶段都需要适当的、经过验证的消毒方法。如使用消毒剂，应证明消毒效果。

4.3.7 Thefollowing controls should be considered:

应考虑以下控制措施:

the maintenance of water flow at all times, in order to preventwater from stagnating;
时刻保持水的流动，防止滞留;

control of temperature in the system by heat exchangers or plantroom cooling in order to reduce the risk of microbial growth (guidance value< 25 °C);
通过热交换器或工厂房间冷却来控制系统内的温度，以减少微生物生长的风险(指导值＜25℃);

the provision of ultraviolet disinfection at appropriate locationsin the system;
在系统的适当位置进行紫外线消毒;

the use of water-treatment system components that can periodicallybe thermally sanitized;
使用可以周期性地进行热消毒的水处理系统组件;

in addition to thermal sanitization, the application of chemicalsanitization such as ozone, hydrogen peroxide and/or peracetic acid; and
除热消毒外，使用化学消毒剂如臭氧、过氧化氢和/或过氧乙酸;以及

thermal sanitization at > 70 °C.
70℃热消毒。

4.3.8 BPWshould have the appropriate action and alert limits for microbiological puritydetermined from a knowledge of the system and data trending. BPW should beprotected from recontamination and microbial proliferation.

纯化水应根据对系统和数据趋势的知识，确定微生物纯度的适当行动和警戒限。应该防止二次污染和微生物繁殖。

4.4 Bulkhighly purified water

高纯水

4.4.1 Bulkhighly purified water (BHPW) must meet the same quality standards as WFI,including the limit for endotoxins.

高纯水(BHPW)必须达到与WFI相同的质量标准，包括内毒素标准。

4.4.2 BHPWshould be prepared from drinking water as a minimum-quality feedwater.

高纯水应最低使用饮用水制备。

4.4.3 Anyappropriate and qualified purification technique, or sequence of techniques,may be used to prepare BHPW. BHPW is often produced by double pass RO coupledwith other suitable techniques such as ultrafiltration and deionization.

可使用适当并经确认的纯化技术，或者技术组合制备高纯水。高纯水通常采用两级反渗透与超滤和去离子等其他适当技术相结合的方法制备。

4.4.4 BHPWshould also be protected from recontamination and microbial proliferation.

还应保护高纯水免受再污染和微生物增殖。

4.4.5 BHPWand WFI have identical microbiological requirements.

高纯水和WFI具有相同的微生物要求。

Note: The guidance provided in section 4.3 for BPW is equally applicable to BHPW.

注:第4.3节提供的纯化水指南同样适用于高纯水。

4.5 Bulkwater for injections

注射用水

4.5.1 Bulkwater for injections (BWFI) should meet the relevant pharmacopoeialspecifications for chemical and microbiological purity (including endotoxins).BWFI is the highest quality of pharmacopoeial WPU.

注射用水(BWFI)应符合相关药典的化学和微生物纯度(包括内毒素)标准。注射用水是最高质量的制药用水。

4.5.2 BWFIis not sterile water and is not a final dosage form. It is an intermediate bulkproduct suitable to be used as an ingredient during formulation.

散装注射用水不是无菌水，也不是成品制剂。它是一种适合在配方中作为配料使用的中间体产品。

4.5.3 Asa robust technique should be used for the production of BWFI, the followingshould be considered when designing a water purification system:

注射用水的制备应采用稳健的技术，在设计注射用水系统时应考虑以下因素:

the quality of feedwater (e.g. drinking-water, usually with furthertreatment, or PW);
给水的质量(例如饮用水，通常需要进一步处理，或者PW);

the required water quality specification;
所需的水质标准;

the quantity of water;
水量;

based on the selection of components and type of system, theappropriate URS, qualification and validation;
基于部件和系统类型的选择，适当的URS、确认和验证;

the optimum generator size or generators with variable control toavoid over-frequent start/stop cycling;
制水机最优规格或可调控制的制水机，以避免频繁启动/停止;

blow-down and dump functions; and
吹扫和排放功能;以及

l cool-down venting to avoid contamination ingress.

冷却水排放，防止污染进入。

4.5.4 BWFImay be prepared, for example, by distillation as the final purification step.Alternatively, techniques such as deionisation, electro deionization, nanofiltration, ultrafiltration, water softening, descaling, pre-filtration anddegasification, ultraviolet treatment, along with other techniques, may beconsidered in conjunction with a single or double pass RO system.

注射用水可以通过蒸馏作为最后的提纯步骤来制备。或者，诸如去离子、电去离子、纳米过滤、超滤、水软化、除垢、预过滤和除气、紫外线处理以及其他技术，可以与一级或两级反渗透系统一起考虑。

4.5.5 BWFIshould have the appropriate action and alert limits and should also beprotected from recontamination and microbial proliferation.

注射用水应有适当的行动和警戒限度，并应防止再污染和微生物增殖。

Note: For a full description, seeProduction of water for injection by means other than distillation.

注:详细说明请参阅非蒸馏法制备注射用水指南。

4.6 Othergrades of water

水的其他级别

When a specific process requires a specialnon-pharmacopoeial grade of water, its specification must be documented withina company’s quality system. As a minimum, it must meet the pharmacopoeialrequirements relating to the grade of WPU required for the type of dosage formor process step.

当一个特定的工艺需要特殊的非药典级别的水时，其标准必须在公司的质量体系中规定。至少，它必须满足与剂型或工艺步骤类型所需的制药用水等级相关的药典要求。

5. General considerations for water purificationsystems

纯化水系统的一般考虑点

5.1 Pharmaceuticalmanufacturers should apply the current principles of quality risk management(6) in selecting and using the appropriate water purification systems. Anappropriate method for the production of WPU should be used.

药物制造商在选择和使用合适的纯化水系统时，应采用现行的质量风险管理原则。制药用水(WPU)的生产应采用合适的方法。

5.2 Risksand controls should be identified for each stage of the production, storage,distribution, use and monitoring of WPU.

制药用水的生产、储存、分配、使用和监测的每个阶段都应确定风险和控制措施。

5.3 Risksidentified should be analyzed and evaluated in order to determine the scope andextent of validation and qualification of the system, including thecomputerized systems used for the production, control and monitoring of WPU.

应分析和评估所识别的风险，以确定该系统的验证和确认的范围和程度，包括用于制备、控制和监测的计算机化系统。

5.4 Riskmanagement should be an ongoing part of the quality management process for WPU.A mechanism to review or monitor events associated with the production,storage, distribution and use of WPU should be implemented.

风险管理应作为制药用水质量管理过程的一个持续的部分。应实施一种机制，以审查或监测与制药用水的生产、储存、分配和使用有关的事件。

5.5 Proceduresfor managing changes and deviations should be followed. Where applicable, theappropriate risk and impact assessments should be done where changes anddeviations are managed.

应遵循变更和偏差的管理程序。适当时，变更和偏差的管理应进行适当的风险和影响评估。

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