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1、ANNEX1MANUFACTUREOFSTERILEMEDICINALPRODUCTS附錄01-無菌藥品制造(2008版>Principle原則Themanufactureofsterileproductsissubjecttospecialrequirementsinordertominimizeb5E2RGbCAPrisksofmicrobiologicalcontamination,andofparticulateandpyrogencontamination.Muchp1EanqFDPw
2、dependsontheskill,trainingandattitudesofthepersonnelinvolved.QualityAssuranceisDXDiTa9E3dparticularlyimportant,andthistypeofmanufacturemuststrictlyfollowcarefullyestablishedRTCrpUDGiTandvalidatedmethodsofpreparationandprocedure.Solerelianceforsterili
3、tyorotherquality5PCzVD7HxAaspectsmustnotbeplacedonanyterminalprocessorfinishedproducttest.jLBHrnAILg無菌藥品制造要求特殊條件,以使得微生物,微粒和熱源污染的風(fēng)險最小。其很大程度上要取決于所涉及到人員技術(shù)水平,培訓(xùn)與態(tài)度。質(zhì)量保證特別重要,這種生產(chǎn)必須嚴(yán)格遵守小心建立的并經(jīng)過驗證的生產(chǎn)方法和工作程序。不能單獨依靠無菌與其它質(zhì)量方面測試來取代最終過程或成品測試。Note:Thisguidancedoe
4、snotlaydowndetailedmethodsfordeterminingthemicrobiologicalandxHAQX74J0Xparticulatecleanlinessofair,surfacesetc.ReferenceshouldbemadetootherdocumentssuchLDAYtRyKfEastheEN/ISOStandards.注:本指南沒有制訂測定空氣,表面等微生物與微粒潔凈度的詳細(xì)方法。請參閱例如EN/ISO標(biāo)準(zhǔn)的其它文件。General總則1.Thema
5、nufactureofsterileproductsshouldbecarriedoutincleanareasentrytowhichZzz6ZB2Ltkshouldbethroughairlocksforpersonneland/orforequipmentandmaterials.CleanareasdvzfvkwMI1shouldbemaintainedtoanappropriatecleanlinessstandardandsuppliedwithairwhichhasrqyn14ZN
6、XIpassedthroughfiltersofanappropriateefficiency.EmxvxOtOco無菌產(chǎn)品制造應(yīng)當(dāng)在潔凈區(qū)域內(nèi)進(jìn)行,進(jìn)入這些區(qū)域內(nèi)的人員和/或設(shè)備與物料,應(yīng)當(dāng)通過氣閘室。潔凈區(qū)必須保持一定的潔凈級別標(biāo)準(zhǔn),空氣必須通過適當(dāng)效率過濾器供給。2.Thevariousoperationsofcomponentpreparation,productpreparationandfillingshouldbeSixE2yXPq5carriedoutinseparatearea
7、swithinthecleanarea.Manufacturingoperationsaredividedinto6ewMyirQFLtwocategories。firstlythosewheretheproductisterminallysterilised,andsecondlythosekavU42VRUswhichareconductedasepticallyatsomeorallstages.y6v3ALoS89各種部件準(zhǔn)備,產(chǎn)品準(zhǔn)備與灌裝,應(yīng)當(dāng)隔離的潔凈區(qū)進(jìn)行。制造操作分為兩類,第一
8、類是產(chǎn)品最終滅菌型,第二類是部分過程或全過程的無菌操作型。3.CleanareasforthemanufactureofsterileproductsareclassifiedaccordingtotherequiredM2ub6vSTnPcharacteristicsoftheenvironment.Eachmanufacturingoperationrequiresanappropriate0YujCfmUCwenvironmentalcleanlinesslevelintheoperati
