药学英语--欧盟GMP第四卷(最新英文原版)

此为最新版的欧盟GMP指南第四卷—人用和兽用药品，更新时间2011.09.01原PDF版下载地址：’ssuppliersandbythedistributors.ToachievethequalityobjectivereliablytheremustbeacomprehensivelydesignedandcorrectlyimplementedsystemofQualityAssuranceincorporatingGoodManufacturingPractice,QualityControlandQualityRiskManagement.Itshouldbefullydocumentedanditseffectivenessmonitored.AllpartsoftheQualityAssurancesystemshouldbeadequatelyresourcedwithcompetentpersonnel,andsuitableandsufficientpremises,equipmentandfacilities.ThereareadditionallegalresponsibilitiesfortheholderoftheManufacturingAuthorisationandfortheQualifiedPerson(s).ThebasicconceptsofQualityAssurance,GoodManufacturingPractice,QualityControlandQualityRiskManagementareinter-related.Theyaredescribedhereinordertoemphasisetheirrelationshipsandtheirfundamentalimportancetotheproductionandcontrolofmedicinalproducts.QualityAssurance1.1QualityAssuranceisawide-rangingconcept,whichcoversallmatters,whichindividuallyorcollectivelyinfluencethequalityofaproduct.Itisthesumtotaloftheorganisedarrangementsmadewiththeobjectiveofensuringthatmedicinalproductsareofthequalityrequiredfortheirintendeduse.QualityAssurancethereforeincorporatesGoodManufacturingPracticeplusotherfactorsoutsidethescopeofthisGuide.ThesystemofQualityAssuranceappropriateforthemanufactureofmedicinalproductsshouldensurethat:(i)medicinalproductsaredesignedanddevelopedinawaythattakesaccountoftherequirementsofGoodManufacturingPractice;(ii)productionandcontroloperationsareclearlyspecifiedandGoodManufacturingPracticeadopted;此为最新版的欧盟GMP指南第四卷—人用和兽用药品，更新时间2011.09.01原PDF版下载地址：(iii)managerialresponsibilitiesareclearlyspecified;(iv)arrangementsaremadeforthemanufacture,supplyanduseofthecorrectstartingandpackagingmaterials;(v)allnecessarycontrolsonintermediateproducts,andanyotherin-processcontrolsandvalidationsarecarriedout;(vi)thefinishedproductiscorrectlyprocessedandchecked,accordingtothedefinedprocedures;(vii)medicinalproductsarenotsoldorsuppliedbeforeaQualifiedPersonhascertifiedthateachproductionbatchhasbeenproducedandcontrolledinaccordancewiththerequirementsoftheMarketingAuthorisationandanyotherregulationsrelevanttotheproduction,controlandreleaseofmedicinalproducts;(viii)satisfactoryarrangementsexisttoensure,asfaraspossible,thatthemedicinalproductsarestored,distributedandsubsequentlyhandledsothatqualityismaintainedthroughouttheirshelflife;(ix)thereisaprocedureforSelf-Inspectionand/orqualityaudit,whichregularlyappraisestheeffectivenessandapplicabilityoftheQualityAssurancesystem.GoodManufacturingPracticeforMedicinalProducts(GMP)1.2GoodManufacturingPracticeisthatpartofQualityAssurancewhichensuresthatproductsareconsistentlyproducedandcontrolledtothequalitystandardsappropriatetotheirintendeduseandasrequiredbytheMarketingAuthorisationorproductspecification.GoodManufacturingPracticeisconcernedwithbothproductionandqualitycontrol.ThebasicrequirementsofGMParethat:(i)allmanufacturingprocessesareclearlydefined,systematicallyreviewedinthelightofexperienceandshowntobecapableofconsistentlymanufacturingmedicinalproductsoftherequiredqualityandcomplyingwiththeirspecifications;(ii)criticalstepsofmanufacturingprocessesandsignificantchangestotheprocessarevalidated;(iii)allnecessaryfacilitiesforGMPareprovidedincluding:•appropriatelyqualifiedandtrainedpersonnel;•adequatepremisesandspace;•suitableequipmentandservices;•correctmaterials,containersandlabels;•approvedproceduresandinstructions;•suitablestorageandtransport;(iv)instructionsandproceduresarewritteninaninstructionalforminclearandunambiguouslanguage,specificallyapplicabletothefacilitiesprovided;(v)operatorsaretrainedtocarryoutprocedurescorrectly;(vi)recordsaremade,manuallyand/orbyrecordinginstruments,duringmanufacturewhichdemonstratethatallthestepsrequiredbythedefinedproceduresandinstructionswereinfacttakenandthatthequantityandqualityoftheproductwasasexpected.Anysignificantdeviationsarefullyrecordedandinvestigated;(vii)recordsofmanufactureincludingdistributionwhichenablethecompletehistoryofabatchtobetraced,areretainedinacomprehensibleandaccessibleform;(viii)thedistribution(wholesaling)oftheproductsminimisesanyrisktotheirquality;(ix)asystemisavailabletorecallanybatchofproduct,fromsaleorsupply;(x)complaintsaboutmarketedproductsareexamined,thecausesofqualitydefectsinvestigatedandappropriatemeasurestakeninres