资源描述：
《欧盟GMP关于无菌室要求.doc》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。
1、ANNEX1MANUFACTUREOFSTERILEMEDICINALPRODUCTS附录01-无菌药品制造(2008版>Principle原则Themanufactureofsterileproductsissubjecttospecialrequirementsinordertominimizeb5E2RGbCAPrisksofmicrobiologicalcontamination,andofparticulateandpyrogencontamination.Muchp1EanqFDPw
2、dependsontheskill,trainingandattitudesofthepersonnelinvolved.QualityAssuranceisDXDiTa9E3dparticularlyimportant,andthistypeofmanufacturemuststrictlyfollowcarefullyestablishedRTCrpUDGiTandvalidatedmethodsofpreparationandprocedure.Solerelianceforsterili
3、tyorotherquality5PCzVD7HxAaspectsmustnotbeplacedonanyterminalprocessorfinishedproducttest.jLBHrnAILg无菌药品制造要求特殊条件,以使得微生物,微粒和热源污染的风险最小。其很大程度上要取决于所涉及到人员技术水平,培训与态度。质量保证特别重要,这种生产必须严格遵守小心建立的并经过验证的生产方法和工作程序。不能单独依靠无菌与其它质量方面测试来取代最终过程或成品测试。Note:Thisguidancedoe
4、snotlaydowndetailedmethodsfordeterminingthemicrobiologicalandxHAQX74J0Xparticulatecleanlinessofair,surfacesetc.ReferenceshouldbemadetootherdocumentssuchLDAYtRyKfEastheEN/ISOStandards.注:本指南没有制订测定空气,表面等微生物与微粒洁净度的详细方法。请参阅例如EN/ISO标准的其它文件。General总则1.Thema
5、nufactureofsterileproductsshouldbecarriedoutincleanareasentrytowhichZzz6ZB2Ltkshouldbethroughairlocksforpersonneland/orforequipmentandmaterials.CleanareasdvzfvkwMI1shouldbemaintainedtoanappropriatecleanlinessstandardandsuppliedwithairwhichhasrqyn14ZN
6、XIpassedthroughfiltersofanappropriateefficiency.EmxvxOtOco无菌产品制造应当在洁净区域内进行,进入这些区域内的人员和/或设备与物料,应当通过气闸室。洁净区必须保持一定的洁净级别标准,空气必须通过适当效率过滤器供给。2.Thevariousoperationsofcomponentpreparation,productpreparationandfillingshouldbeSixE2yXPq5carriedoutinseparatearea
7、swithinthecleanarea.Manufacturingoperationsaredividedinto6ewMyirQFLtwocategories。firstlythosewheretheproductisterminallysterilised,andsecondlythosekavU42VRUswhichareconductedasepticallyatsomeorallstages.y6v3ALoS89各种部件准备,产品准备与灌装,应当隔离的洁净区进行。制造操作分为两类,第一
8、类是产品最终灭菌型,第二类是部分过程或全过程的无菌操作型。3.CleanareasforthemanufactureofsterileproductsareclassifiedaccordingtotherequiredM2ub6vSTnPcharacteristicsoftheenvironment.Eachmanufacturingoperationrequiresanappropriate0YujCfmUCwenvironmentalcleanlinesslevelintheoperati
