2-歐盟GMP中英文對照

5 5 5 5 7 7 9 9產(chǎn)品質(zhì)量回顧 1 2 3 4premises,equipmentandfacilities.ThertheManufacturingAuthorisationtheirfundamentalimpor5otherfactorsoutsidethescope藥品質(zhì)量符合預(yù)期使用目的而進(jìn)行組織管理的總和。因此質(zhì)量保證是由GMPThesystemofQualityAssurance6stored,distributedandeffectivenessandapplicabilityoftheQualityArequiredqualityandcomplyingi.所有生產(chǎn)工藝應(yīng)有明確規(guī)定，根據(jù)經(jīng)驗進(jìn)行系統(tǒng)的審核，并證7f.suitablestorageandtranslanguage,specificallyapplicabletotakenandthatthequantity8sampling,specificationsandtesting,andwiththeorgaproducts,andwhereapprrequiredsampling,inspectingandv.thefinishedproductscontainquantitativecompositenclosedwithintheirpr9fromspecifiedprocedu(8)對所有與質(zhì)量相關(guān)的退貨、投訴、召回進(jìn)行回顧Theestablishmentandmaintena(c)受權(quán)人在產(chǎn)品放行前必須在記錄或相應(yīng)文件中證明每批產(chǎn)品符合第22條theholderoftheManufacturingAuthorisationtov.toensurethattheappropriatevavii.toensurethattheappropriateva2.11Visitorsoruntrainedpersonnelshould,preferably,nounderstandingandimp2.20Anyspecificrequirementsforthemanufacapplicable,disinfectedaccordingtodetailedwrimanufactureandstorage,ortheaccurate3.5Stepsshouldbetakeninordertopreventtheentdedicatedandselfconta藥品[如：高致敏性物質(zhì)（如：青霉素類）或生物differentmedicinalproductsortheirenvironment,interiotoavoidthecreationohandled,totheoperationsundertakenwithinoperations,packagingofdryproducts),specificprovisionsshouldbetakentoavoidcross-contaminationandfaciphysicalquarantineshouldgiveequcontaminationorcrosparticularlyimportantforlaboradioisotopes,whichshouldavailableforproductionandcon3.43Distilled,deionizedand,whereappropriate,otherwaterpipesshouldbesanitisedaccordingtowrittenproceduresthaandthemeasurestobetaken.writtendocumentatioProceduresgivedirectionsfenvironmentalcontrol,sampling,testing,equiotherrelevantcircumstwaythatallsignificant4.10Thereshouldbeappropriatelyauc)qualitativeandquantitativevaluationofthefinishedproduct.ThespecificationssstartingmaterialsorforfinisheSpecificationsforfinished4.13Specificationsforfine)thequalitativeandquantitativereqf)thestorageconditionsequipment(e.g.cleaning,assembling,calibratin）；sequenceforaddingmaterials,mixingtimes,td)theinstructionscontainer,labellingandspecialstorageconditionsb)descriptionofitspharmaceuticresponsiblefortheprocessingopeappropriate,ofthepersonwhocheckedeanumberandtheplannedandworkstationareclearofpreviousproducts,documentsormaterialsnotrequiredfortheforthepackagingoperatd)theinitialsoftheoperatorofthebatchcoding,expif)totalquantity,andnu4.22Thereshouldbetotakesamples,themethodsandequipmenttobeused,theamaccordancewiththerequirementsofArticle22ofDirect4.24.應(yīng)制定物料和產(chǎn)品放行和拒收的書面規(guī)程，尤conclusionsreached,whereaa）validation;b）equipmentassemblyandcalibrad）personnelmattersincludingtraining,f）pestcontrol;anyvalidations,calibrations,mtheywerestartingma5.11Whenworkingwithdrymaterialsandproducts,specialprecautionsshouldbetakentoWhereapplicable,thisindcolourstoindicatestatheequipmentdestinedfortheonequipment,andfro5.19Cross-contamination），c)將再循環(huán)空氣、或未經(jīng)處理或處理不徹底的空氣進(jìn)入而引起的污染危cross-contaminationcleaningofequipmentisacommonsourceofcrValidationbetakentodemonstrateitssuitabilityforroutineprocessing.Thedefinedprocesthespecificationsescomplaintsandrejectio5.27Foreachdelivery,thecontainersshouldbecheckedforintegrityofseparateforsampling,testing）；5.35Beforeanyprocessingoperationisstarted,stepsshouldbetakentoen5.40Thepurchase,handlingandcontrolofprimaccordedattentionsimi5.45Beforepackagingoperationsarebegun,stepsshouldbetakentoensur5.51Specialcareshouldbetakenwhenusingcut-labelsandwhenover-printingiscasimilardevicesareoperati5.56Anysignificantorunusualdi5.58Finishedproductsshouldbeheldinquarantinofproductforsalear5.59.成品放行前需進(jìn)行的成品和文件的審核，見第六章質(zhì)量控制。thetimeelapsedsinceitwasissuedshouldallbetakenintQualityControliscorganisation,documenfundamentaltothesatisfactoryowrittenproceduresandconditions,resultsofin-processtesting,areviewofmanufacturing(includingpackaging)6.5.質(zhì)量控制實驗室的房屋設(shè)施和設(shè)備應(yīng)符合第三章《廠房和設(shè)備》中對6.6Thepersonnel,premises,andequipmentinthelaboratoriesshouldbeappropriatetothepartofthisdocumen—datafromenvironmentalmon—validationrecordsoftestmethods,—theamountofthesampletobetaken;—theidentificationofwhichtheyaretaken.Othersamplesmayalsobetakentomonprocess(e.g.beginningo6.13.樣品瓶應(yīng)貼標(biāo)簽，標(biāo)明其內(nèi)容物、批號、取樣日witheachother.Anycalculatioc)referencestotheg)initialsofthepersonswhoverifiedtaccordancewithwritaddition,forvolumetricsolutions,thelastechnicalorotherarrange7.2.委托生產(chǎn)和委托檢驗的所有安排（包括技術(shù)上的變更或其它安排）都ContractAcceptorisfullexperience,andcompetentpersonneltocarryoutsatisfactorilytheworkorderedbythearrangements.Arrangemequalityoftheproductmanwhichspecifiestheirrespectiveresponsibilitiesrelatingtothemanufactureandcontrolofthethecontractshouldstatewhetherthedefect/recallprocedureAcceptor.