EUGMP中英文对照1.docx

EUGMPANNEX1
MANUFACTUREOFSTERILEMEDICINALPRODUCTS
（中英文对照）

Principle原则Themanufactureofsterileproductsissubjecttospecialrequirementsinordertominimizerisksofmicrobiologicalcontamination,andofparticulateandpyrogencontamination.Muchdependsontheskill,trainingandattitudesofthepersonnelinvolved.QualityAssuranceisparticularlyimportant,andthistypeofmanufacturemuststrictlyfollowcarefullyestablishedandvalidatedmethodsofpreparationandprocedure.Solerelianceforsterilityorotherqualityaspectsmustnotbeplacedonanyterminalprocessorfinishedproducttest.无菌药品的生产，必须符合一些特殊的要求，以防止微生物、微粒和热源的污染。这很大程度上要取决于相关人员的技术水平、培训和工作态度。在这方面质量保证显得特别重要，这种类型的生产，必须严格按照完善的和经过验证的生产方法和工作程序。仅基于产品的最终灭菌或产品检验结果来相信其无菌性和其他质量指标是不可靠的。Note:Thisguidancedoesnotlaydowndetailedmethodsfordeterminingthemicrobiologicalandparticulatecleanlinessofair,surfacesetc.ReferenceshouldbemadetootherdocumentssuchastheEN/ISOStandards.注：本指南没有详述测定洁净区内微生物和尘埃粒子、表面的详细方法，请参阅EN/ISO中相关标准。General总则1.Themanufactureofsterileproductsshouldbecarriedoutincleanareasentrytowhichshouldbethroughairlocksforpersonneland/orforequipmentandmaterials.Cleanareasshouldbemaintainedtoanappropriatecleanlinessstandardandsuppliedwithairwhichhaspassedthroughfiltersofanappropriateefficiency.无菌产品的生产要在洁净区域内进行，进入这些区域内的人员、设备或物料，必须通过气闸室。洁净区必须保持一定的洁净级别，空气必须通过适宜效率的过滤器2.Thevariousoperationsofcomponentpreparation,productpreparationandfillingshouldbecarriedoutinseparateareaswithinthecleanarea.Manufacturingoperationsaredividedintotwocategories;firstlythosewheretheproductisterminallysterilised,andsecondlythosewhichareconductedasepticallyatsomeorallstages.各种成分的制备、产品的制备和灌装，必须在洁净区的不同区域进行。生产操作分为两类，一是产品最终灭菌型，二是部分过程或全过程的无菌操作
3.Cleanareasforthemanufactureofsterileproductsareclassifiedaccordingtotherequiredcharacteristicsoftheenvironment.Eachmanufacturingoperationrequiresanappropriateenvironmentalcleanlinesslevelintheoperationalstateinordertominimizetherisksofparticulateormicrobialcontaminationoftheproductormaterialsbeinghandled.Inordertomeet“inoperation”conditionstheseareasshouldbedesignedto