【英文标准名称】:StandardGuideforApplicationofContinuousQualityVerificationtoPharmaceuticalandBiopharmaceuticalManufacturing
【原文标准名称】:药品和生物药品生产中持续质量验证的标准指南
【标准号】:ASTME2537-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E55.03
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:continuousimprovement;continuousqualitymonitoring;continuousqualityverification;processcapabilityanalysis;processcontrolstrategy;processunderstanding;real-timerelease
【摘要】:Applicationoftheapproachdescribedwithinthisstandardguideappliesscience-basedconceptsandprinciplesintroducedintheFDAinitiativePharmaceuticalcGMPsforthe21stCentury.Thisguidesupports,andisconsistentwith,elementsfromICHQ8andICHQ9.AccordingtoFDAGuidanceforIndustry,PAT,x201C;Withrealtimequalityassurance,thedesiredqualityattributesareensuredthroughcontinuousassessmentduringmanufacture.Datafromproductionbatchescanservetovalidatetheprocessandreflectthetotalsystemdesignconcept,essentiallysupportingvalidationwitheachmanufacturingbatch.x201D;Inotherwords,theaccumulatedproductandprocessunderstandingusedtoidentifytheCriticalQualityAttributes(CQAs),togetherwiththeknowledgethattherisk-basedmonitoringandcontrolstrategywillenablecontroloftheCQAs,shouldprovidetheconfidenceneededtoshowvalidationwitheachbatch.Thisisasopposedtoaconventionaldiscreteprocessvalidationapproach.1.1ThisguidedescribesContinuousQualityVerification(CQV)asanapproachtoprocessvalidationwheremanufacturingprocess(orsupportingutilitysystem)performanceiscontinuouslymonitored,evaluatedandadjusted(asnecessary).Itisascience-basedapproachtoverifythataprocessiscapableandwillconsistentlyproduceproductmeetingitspredeterminedcriticalqualityattributes.CQVissimilarlydescribedasContinuousQualityAssurance(U.S.FDA)andContinuousProcessVerification(ICHQ8).1.2Pharmaceuticalandbiopharmaceuticalproductmanufacturingcompaniesarerequiredtoprovideassurancethattheprocessesusedtomanufactureregulatedproductsresultinproductswiththespecifiedcriticalqualityattributesofstrengthidentityandpurityassociatedwiththeproductsafety,andefficacy.Processvalidationisawayinwhichcompaniesprovidethatassurance.1.3Withtheknowledgeobtainedduringtheproductlifecycle,aframeworkforcontinuousqualityimprovementwillbeestablishedwherethefollowingmaybepossible:(1)riskmitigated,(2)processvariabilityreduced,(3)processcapabilityenhanced,(4)processdesignspacedefinedorenhanced,andultimately(5)productqualityimproved.Thiscanenableanumberofbenefitsthataddressbothcomplianceandoperationalgoals(forexample,realtimerelease,continuousprocessimprovement).1.4Theprinciplesinthisguidemaybeappliedtodrugproductoractivepharmaceuticalingredient/drugsubstancepharmaceuticalandbiopharmaceuticalbatchorcontinuousmanufacturingprocessesorsupportingutilitysystems(forexample,TOCforPurifiedWaterandWaterforInjectionsystems,andsoforth).1.5Theprinciplesinthisguidemaybeappliedduringthedevelopmentandmanufacturingofanewprocessorproductorfortheimprovementand/orredesignofanexistingprocess.1.6Continuousqualityverificationmaybeappliedtomanufacturingprocessesthatusemonitoringsystemsthatprovidefrequentandobjectivemeasurementofprocessdata.Theseprocessesmayormaynotemployin-,on-,orat-lineanalyzers/controllersthatmonitor,measure,analyze,andcontroltheprocessperformance.Theassociatedprocessesmayormaynothaveadesignspace.1.7ThisguidemaybeusedindependentlyorinconjunctionwithotherproposedE55standardstobepublishedbyASTMInternational.
【中国标准分类号】:C00
【国际标准分类号】:11_120_01
【页数】:4P.;A4
【正文语种】:英语