EU-GMP 附录一 翻译搞.doc

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1、ANNEX1附件1MANUFACTUREOFSTERILEMEDICINALPRODUCTS无菌医药产品的生产Principle原则Themanufactureofsterileproductsissubjecttospecialrequirementsinordertominimiserisksofmicrobiologicalcontamination,andofparticulateandpyrogencontamination.Muchdependsontheskill,trainingandattitudesofthepersonne

2、linvolved.QualityAssuranceisparticularlyimportant,andthistypeofmanufacturemuststrictlyfollowcarefullyestablishedandvalidatedmethodsofpreparationandprocedure.Solerelianceforsterilityorotherqualityaspectsmustnotbeplacedonanyterminalprocessorfinishedproducttest.无菌药品的生产，必须符合一些特殊

3、的要求，以防止微生物、微粒和热源的污染。这很大程度上要依赖工作人员的技术水平、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。仅靠产品的最终灭菌和某一方面的质量控制是不允许的。Note:Thisguidancedoesnotlaydowndetailedmethodsfordeterminingthemicrobiologicalandparticulatecleanlinessofair,surfacesetc.Referenceshouldbemadetootherdocume

4、ntssuchastheEN/ISOStandards.注：本规范没有详述测定空气、表面等微生物和微粒洁净度的详细方法，请参阅EN/ISO中相关标准。General一般要求1.Themanufactureofsterileproductsshouldbecarriedoutincleanareasentrytowhichshouldbethroughairlocksforpersonneland/orforequipmentandmaterials.Cleanareasshouldbemaintainedtoanappropriateclean

5、linessstandardandsuppliedwithairwhichhaspassedthroughfiltersofanappropriateefficiency.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、设备或原料，必须通过气闸室。洁净区必须保持一定的洁净级别，空气必须通过规定的过滤器。2.Thevariousoperationsofcomponentpreparation,productpreparationandfillingshouldbecarriedoutinseparateareaswithintheclea

6、narea.Manufacturingoperationsaredividedintotwocategories;firstlythosewheretheproductisterminallysterilised,andsecondlythosewhichareconductedasepticallyatsomeorallstages.各种原料的准备、产品的准备和灌装，必须在洁净区的不同区域进行，生产操作分为两类，一是最终灭菌型，二是部分过程或全过程的无菌操作。3.Cleanareasforthemanufactureofsterileprod

7、uctsareclassifiedaccordingtotherequiredcharacteristicsoftheenvironment.Eachmanufacturingoperationrequiresanappropriateenvironmentalcleanlinesslevelintheoperationalstateinordertominimisetherisksofparticulateormicrobialcontaminationoftheproductormaterialsbeinghandled.Inorderto

8、meet“inoperation”conditionstheseareasshouldbedesignedtoreachcertainspecifie