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1、EUROPEANCOMMISSIONENTERPRISEANDINDUSTRYDIRECTORATE-GENERALConsumergoodsPharmaceuticalsBrussels,25November2008(rev.)EudraLexTheRulesGoverningMedicinalProductsintheEuropeanUnionVolume4EUGuidelinestoGoodManufacturingPracticeMedicinalProductsforHumanandVeterinaryUseAnnex1ManufactureofSterile
2、MedicinalProducts(correctedversion)DocumentHistoryPreviousversiondated30May2003,inoperationsinceSeptember2003Revisiontoalignclassificationtableofcleanrooms,toincludeNovember2005toguidanceonmediasimultations,bioburdenmonitoringandcappingDecember2007ofvials1Dateforcomingintooperationandsup
3、erseding01March2009Pleasenotecorrectionontheimplementationofprovisionsforcappingofvials!1Note:Provisionsoncappingofvialsshouldbeimplementedby01March2010.CommissionEuropéenne,B-1049Bruxelles/EuropeseCommissie,B-1049Brussel–Belgium.Telephone:(32-2)2991111ANNEX1MANUFACTUREOFSTERILEMEDICINAL
4、PRODUCTSPrincipleThemanufactureofsterileproductsissubjecttospecialrequirementsinordertominimizerisksofmicrobiologicalcontamination,andofparticulateandpyrogencontamination.Muchdependsontheskill,trainingandattitudesofthepersonnelinvolved.QualityAssuranceisparticularlyimportant,andthistypeo
5、fmanufacturemuststrictlyfollowcarefullyestablishedandvalidatedmethodsofpreparationandprocedure.Solerelianceforsterilityorotherqualityaspectsmustnotbeplacedonanyterminalprocessorfinishedproducttest.Note:Thisguidancedoesnotlaydowndetailedmethodsfordeterminingthemicrobiologicalandparticulat
6、ecleanlinessofair,surfacesetc.ReferenceshouldbemadetootherdocumentssuchastheEN/ISOStandards.General1.Themanufactureofsterileproductsshouldbecarriedoutincleanareasentrytowhichshouldbethroughairlocksforpersonneland/orforequipmentandmaterials.Cleanareasshouldbemaintainedtoanappropriateclean
7、linessstandardandsuppliedwithairwhichhaspassedthroughfiltersofanappropriateefficiency.2.Thevariousoperationsofcomponentpreparation,productpreparationandfillingshouldbecarriedoutinseparateareaswithinthecleanarea.Manufacturingoperationsaredividedintotwocategories;firstlytho
