制药用水和蒸汽系统指南

AGUIDEFORNEWFACILITIES为新型设施准备的指南VOLUME4:WATERANDSTEAMGUIDE卷4：水和蒸汽系统的指导原则EXECUTIVESUMMARY执行概况DECEMBER20002000年12月ADOCUMENTDEVELOPEDINPARTNERSHIPWITHFDA本文件由下列单位与FDA合作编写ISPEPHARMACEUTICALENGINEERINGGUIDE/ISPE制药工程指南FOREWORD/序Formanyyears,thepharmaceuticalindustryhasexperiencedincreasesinthecostofnewfacilities.Theseincreasesincosthavebeendriveninpartbyuncertaintyabouttherequirementsforregulatorycompliance.Somesignificantareasofconcernarevalidation,particularlyrelatedtoautomationsystems,andthetrendtovalidatebacktosourceutilities.Theabsenceofaconsistentandwidelyacceptedinterpretationofsomeregulatoryrequirementshasledtoone-upmanship.Thispracticeofbuildingincreasinglytechnicallyadvancedfacilitieshasledtoincreasedcost,longerleadtimesand,insomecases,delaysinbringingnewproductstomarket.长年以来，制药行业在购进的大量新设施方面的支出一直持续增长。造成这些支出的部分原因是法规符合力度的要求的无常。验证是得到重点关注的方面之一，特别是与自动化系统、回溯验证源效用的趋势、建筑和HVAC有关的内容。一致且得到广泛接受的法规要求的欠缺造就了突出的情况：对技术先进的设施的追求导致成本的剧增、交货与订货之间所需时间的延长、以及，在某些情况下，可导致新产品上市的延期。InMay1994,engineeringrepresentativesfromthepharmaceuticalindustryengagedinadiscussionwiththeInternationalSocietyforPharmaceuticalEngineering(ISPE)andtheFoodandDrugAdministration(FDA).AsaresultofthatdiscussioninNovember1994,ISPEbeganworkon10facilityengineeringGuides,nowknownastheBaseline®PharmaceuticalEngineeringGuides.Thefirst,“BulkPharmaceuticalChemicals,”waspublishedinJune1996.Thesecond,“OralSolidDosageForms,’”waspublishedinFebruary1998.Thethird,“SterileManufacturingFacilities,”waspublishedinFebruary1999.ThisisthefourthsuchGuide,coveringPharmaceuticalWaterandSteamSystems.EachEngineeringGuidewascreatedby,andisownedsolelybyISPE.FDAprovidedcommentsonthisandpreviousGuides,andmanyoftheirsuggestionshavebeenincorporated.1994年5月，制药行业的技术代表与国际制药工程协会（ISPE）和美国食品与药品监督管理局（FDA）召开了讨论会。讨论的结果是从1994年11月起，ISPE开始致力于10本设施工程学指南的编写，这10本指南也就是现在为大家所熟知的Baseline®制药工程指南。1996年6月出版的指南的第一卷的内容是关于批量药用化学品（BPC）的，第2本，“口服固体制剂”出版于1998年2月；第3本，“无菌生产设施”出版于1999年2月。本指南是这个系列的第4卷，介绍的是制药用水和蒸汽系统的内容。每本指南都由ISPE编写，其版权归ISPE独家拥有。FDA对这本指南和本系列之前出版的指南的编写都给予了宝贵意见，这些意见很多都已经整合入本系列丛书中。AswiththeBPCGuide,OSDandSterileGuide,theWaterandSteamGuidehasbeensponsoredbyISPE’sPharmaceuticalAdvisoryCouncil,madeupofseniorpharmaceuticalengineeringexecutivesfromownercompanies,andISPEseniormanagement.Overallplanning,directionandtechnicalguidanceinthepreparationoftheWaterandSteamGuidewasprovidedbyaSteeringCommitteemostofwhomwereinvolvedintheBPCGuide.TheWaterandSteamGuideitselfwasproducedbyaTaskTeamofindividualswhoexpendedagreatdealoftheirowntimeinitspreparationanddevelopment.与BPC指南、OSD和无菌指南相同，这本水和蒸汽系统指南也得到了ISPE的药品咨询委员会的赞助；该委员会的成员由企业自身的制药工程高中级资深管理人员、FDA和ISPE管理高层组成。指导委员会为《调试和合格确认指南》的编写提供整体规划、方向的定位和技术指导；该委员会主要由参与BPC指南编写的人员组成。《水和蒸汽系统指南》的编写工作组的成员为这本书的编写和发展花费了大量私人时间。Editors’Disclaimer:/编辑的声明ThisGuideismeanttoassistpharmaceuticalmanufacturersinthedesignandconstructionofnewandrenovatedfacilitiesthatarerequiredtocomplywiththerequirementsoftheFoodandDrugAdministration(FDA).TheInternationalSocietyforPharmaceuticalEngineering(ISPE)cannotensure,anddoesnotwarrant,thatafacilitybuiltinaccordancewiththisGuidewillbeacceptabletoFDA.本指南旨在给药品生产者提供符合美国食品与药品监督管理局（FDA）要求的新设施的设计和构造方面的协助。国际制药工程协会（ISPE）并不为按照本指南要求建造的工厂通过FDA的检查提供担保和保证。ThisdocumentisownedbyISPE.NoreproductionofthewholeoranypartofthisdocumentistobemadewithoutthewrittenauthorityofISPE.本文件的版权归ISPE所有。任何人不得在没有得到ISPE的授权信的情况下复制本文件的全部或部分内容。ACKNOWLEDGEMENTS/感谢CHAPTERWRITERSANDREVIEWERS/各章的编写人和审查人Thefollowingindividualstookleadrolesinthepreparationofthisdocument:以下人士在本文件的编写过程中发挥了带头作用：GeraldL.Geisler,Bristol-MyersSquibbCo.wasTeamLeaderforthePharmaceuticalWaterandSteamGuide.MoeElmorsi,BoehringerIngelheim,actedstheGuidementor.GuidesSteeringCommitteeChairPaulLorenzo,(Retired)/PaulD’Eramo,Johnson&JohnsonTheCoreTeamonthePharmaceuticalWaterandSteamGuidecomprised:GeraldL.Geisler,Bristol-MyersSquibbCo.RobertMyers,KvaernerJeffBiskup,Clark,Richardson&BiskupBobBader,KineticsTheChapterCreditsareasfollows:GeraldGeisler,Bristol-MyersSquibbCo.Chapter1:IntroductionBrianOwens,H2OPure,Inc.GeraldGeisler,Bristol-MyersSquibbCo.Chapter2:KeyDesignPhilosophiesBrianOwens,WaterPure,Inc.JeffreyBiskup,Clark,Richardson&Chapter3:WaterOptionsandProgrammingBiskupMariaCapote,SourceTechJamesC.Cox,Merck&Co.GeraldL.Geisler,Bristol-MyersSquibbCo.RyanSchroeder,Clark,Richardson&BiskupSidneyBrookes,DuPontMerckPharmaceuticalsChapter4:SourceFeedWaterQualityandPretreatmentISPEBASELINEGUIDEWATERANDSTEAMEXECUTIVESUMMARYDECEMBER2000MichaelPartow,PfizerInc.AndrewZaske,OsmonicsGaryZoccalante,U.S.FilterChapter5:FinalTreatmentNon-CompendialandCompendialPurifiedWaterSharifDisi,MecoBrianOwens,H2OPure,Inc.Chapter6:FinalTreatmentCompendialWFIBrianOwens,H2OPure,Inc.BobBader,KineticsChapter7:PharmaceuticalSteamRobertMyers,KvaernerGaryGray,EastGroupBobBader,KineticsRandolphBrozek,Pfizer,Inc.JamesCox,Merck&CoPaulSkinner,Clark,Richardson&BiskupGeraldGeisler,Bristol-MyersSquibbCo.Chapter8:StorageandDistributionSystemsJohnLinder,CE&ICDebraNahas,EliLilly&Co.Chapter9:InstrumentationandControlJohnFadool,GlaxoWellcomeRobertMyers,KvaernerManfredSeptinus,RocheCarolina