WHO《制药用水GMP指南》-2020草案(中英文对照版)

1/25WorkingdocumentQAS/20.842工作文件QAS/20.842May2020二零二零年五月DRAFTWORKINGDOCUMENTFORCOMMENTS:征求意见草案:Goodmanufacturingpractices:优良制造规范（GMP）:waterforpharmaceuticaluse制药用水2/25Background背景Thecontrolofwaterquality,includingmicrobiologicalandchemicalquality,throughoutproduction,storageanddistributionprocessesisamajorconcern.Unlikeotherproductandprocessingredients,waterisusuallydrawnfromanon-demandsystemandisnotsubjecttotestingandbatchorlotreleasepriortouse.Theassuranceofwaterqualitytomeettheon-demandexpectationis,therefore,essential.水的制备、存贮和分配过程中对水质的控制，包括微生物和化学质量，是一个重要关注点。与其它产品和工艺成分不同，水通常是来自一个按需运行的系统，在使用之前不会进行检测，也不会进行批放行，因此确保水质符合所需要求就至关重要了。Inrecentyears,followingextensiveconsultationwithstakeholders,severalpharmacopoeiashaveadoptedrevisedmonographsonwaterforinjection(WFI)thatallowforproductionbynon-distillationtechnologies,suchasreverseosmosis(RO).In2017,theWorldHealthOrganization(WHO)ExpertCommitteeonSpecificationsforPharmaceuticalPreparations(ECSPP)recommendedthattheWHOSecretariatcollectfeedbackonwhetherornottheyshouldrevisetheWHOspecificationsandgoodmanufacturingpractices(GMP)onWFI,andhowtodoso.Followingdiscussionsduringseveralconsultations,theECSPPagreedthatthemonographinTheInternationalPharmacopoeia(Waterforinjections)andtheguidelineWHOGoodmanufacturingpractices:waterforpharmaceuticaluse(1)shouldbothberevisedtoallowfortechnologiesotherthandistillationfortheproductionofWFI.Inearly2019,theWHOSecretariatcommissionedthepreparationofadraftguidancetextfortheproductionofWFIbymeansotherthandistillation.Followingseveralpublicconsultations,thetextwaspresentedtotheFifty-fourthECSPP.TheExpertCommitteeadoptedtheProductionofwaterforinjectionbymeansotherthandistillationguidelineandrecommendedthatitshouldalsobeintegratedintoWHO’sexistingguidelineonGoodmanufacturingpractices:waterforpharmaceuticaluse.近年来，由于干系人提出非常多的建议，几部药典均对注射用水（WFI）进行了修订，允许采用非蒸馏技术如反渗透（RO）制备WFI。2017年，WHO制剂标准专家委员会（ECSPP）建议WHO秘书处收集各方对于是否认为应修订WHO标准和WFIGMP以及如何修订的反馈。在几次征求意见期间经过讨论之后，ECSPP同意对国际药典各论（注射用水）和WHO指南“GMP：制药用水”进行修订，允许使用非蒸馏技术制备WFI。2019年早期，WHO秘书处协调起草了非蒸馏方法制备WFI的指南草案。经过几次公开征求意见之后，该文件被提交给第54次ECSPP。专家委员会采纳了“非蒸馏方法制备注射水”的指南，并将建议整合至WHO现有指南“GMP：制药用水”中。ThiscurrentdocumentisarevisionofWHOGoodmanufacturingpractices:waterforpharmaceuticaluse,previouslypublishedintheWHOTechnicalReportSeries,No.970,Annex2,2011.本文件是之前发布为WHOTRS970附录2，2011的“WHOGMP：制药用水”修订本。1.Introduction介绍2.Backgroundtowaterrequirementsanduses水的要求和用途背景3.Generalprinciplesforpharmaceuticalwatersystems制药用水系统的一般原则4.Waterqualityspecifications水的质量标准4.1.Pharmacopoeialspecifications药典标准4.2.Drinking-water3/25饮用水4.3.Bulkpurifiedwater纯化水4.4.Bulkhighlypurifiedwater高纯水4.5.Bulkwaterforinjections注射用水4.6.Othergradesofwater其他级别的水5.Generalconsiderationsforwaterpurificationsystems水净化系统的一般考虑点6.Waterstorageanddistributionsystems储存和分配系统7.Goodpracticesforwatersystems水系统良好规范8.Systemsanitizationandbioburdencontrol系统消毒与生物污染控制9.Storagevessels储罐10.Waterdistribution分配系统11.Biocontaminationcontroltechniques生物污染控制技术12.Operationalconsiderations运行的考虑点12.5Phase1第一阶段12.6Phase2第二阶段12.7Phase3第三阶段13.Continuoussystemmonitoring持续系统监测14.Maintenanceofwatersystems水系统的维护15.Systemreviews系统回顾16.Inspectionofwatersystems水系统的检查17.References参考资料18.Furtherreading延伸阅读4/251Introductionandscope介绍及范围1.1Thisdocumentconcernswaterforpharmaceuticaluse(WPU)produced,storedanddistributedinbulkform.ItintendstoprovideinformationaboutdifferentspecificationsforWPU;guidanceonGMPregardingthequalitymanagementofwatersystems;watertreatment(production)systems;waterstorageanddistributionsystems;qualificationandvalidation;andsampling,testingandtheroutinemonitoringofwater.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。1.2Althoughdrinking-waterisaddressed,thefocusofthisdocumentisonthetreatment,storageanddistributionoftreatedwaterusedinpharmaceuticalapplications.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。1.3Thisdocumentdoesnotcoverwaterforadministrationtopatientsintheformulatedstateortheuseofsmallquantitiesofwaterinpharmaciestocompoundindividuallyprescribedmedicines.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。1.4Thedocumentcanbeusedinwholeorinpart,asappropriate,tothesectionandapplicationunderconsideration.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。1.5Inadditiontothisdocument,the“Furtherreading”sectionattheendofthisdocumentincludessomerelevantpublicationsthatcanserveasadditionalbackgroundmaterialwhenplanning,installingandusingsystemsintendedtoprovideWPU.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。1.6ThisdocumentissupplementarytotheWorldHealthOrganization(WHO)Goodmanufacturingpracticesforactivepharmaceuticalingredients(2),andWHOGoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples(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.Backgroundtowaterrequirementsanduses水的要求和使用背景2.1Waterisawidelyusedsubstanceinthepharmaceuticalindustry.Itisextensivelyusedasarawmaterialorstartingmaterialintheproduction,processingandformulationofactivepharmaceuticalingredients(APIs),intermediatesandfinishedpharmaceuticalproducts(FPP),inthepreparationofsolvent