KGMP-Rev.-4-2008-韩国GMP

THEGOODMANUFACTURINGPRACTICEFORPHARMACEUTICALPRODUCTSINKOREA(KGMP)issued2008.01.15MinistryofHealthandSocialAffairsKoreaPharmaceuticalManufacturersAssociation1.DefinitionoftermsDefinitiongivenbelowappliestothetermsasusedinthesestandards.1)“Controlnumber”meansnumbersgiventomaterialsandetc.whichisnotapplicableformanufacturingunitinordertocontrolthemanditcanbenumbers,textsorcombinationofnumbersandtexts.2)“Calibration”meanstodemonstratethatameasuringinstrument,testinginstrumentsorrecordingdeviceproducesresultswithinallowablemarginoferrorbycomparisonwiththoseproducedbyareferenceandtoadjusttheinstrumentordevicetoproduceresultswithinthemarginifitproducesresultsoutofthemargin.3)“Deviation”meansactionswhichdeparturefromanestablishedstandardduringaprocessofproductionorqualitycontrol.4)“Out-of-specification(OOS)”meansthatatestresultisoutofanestablishedspecificationofthetest.5)“Asepticarea”meansworkareaswhereasepticmaterialorsterilizedcontainersareexposedtotheairandareaswherefillingorsealingofsterileproductsisconducted.Anditincludesareawhereasepticoperationsasaseptictestareconducted.6)“Intermediateproduct”meanstheproductintheprocesses,whichmustundergofurtherthenecessaryprocessbeforeitbecomesafinishedproduct.7)“Validation”meanstheverificationanddocumentationthataspecificprocess,method,mechanicalinstrumentorsystemwillconsistentlyproducearesultmeetingpre-determinedacceptancecriteria.8)“Yield”meansthepercentageofactualproductionquantityonthetheoreticalproductionquantity.9)“Yieldcontrolcriteria”meansarangeofmeanproductionyieldofeachproductwhenmanufacturingprocedureswerecarriedoutnormally.10)“Actualproductionquantity”meansactualquantitywhichwasyieldedfromamanufacturingprocedure.11)“Finisheddrugproduct”meansadrugproductinacertainpharmaceuticalformwhichhasundergoneallstagesofproductionandisfinallygoingtobeadministeredtohumanbody.12)“Finishedproduct”meansafinisheddrugproductoradrugsubstancewhichhasundergoneallstagesofproduction.13)“Rawmaterial”meansanysubstanceusedintheproductionofafinishedproductincludingthosethatmightnotbepresentinthefinishedproduct.(Packingmaterialsareexcluded).14)“Drugsubstance”meansasubstancewhichwasmanufacturedthroughsynthesis,fermentation,extractionorcombinationofthesestepsandusedintheproductionofafinisheddrugproduct.15)“Material”meansarawmaterialorapackingmaterial.16)“Theoreticalyield”meansquantityofanintermediateproductorafinishedproductthatistheoreticallycalculatedbaseduponinputamountofdrugsubstances.17)“Packagingmaterial”meansanymaterialusedforpackagingandlabeling,includingcontainer.18)“Reprocessing”meanstorepeatpartsofpre-determinedmanufacturingstepsforanintermediateproductwhichdeviatesfromthestandard.19)“Acceptanceevaluation”meanstoverifyanddocumentthatmachineriesandfacilitiesaremanufacturedandinstalledasdesignedandworkasandd20)“Production”meansalloperationsinvolvedintheproductionofamedicinalproductincludingpackagingandlabeling.21)“Batch”or“Lot”meansadefinedquantityofthedrugmanufacturedinthesameprocesssothatitcouldbeexpressedtobehomogeneous22)“Batchnumber”or“Lotnumber”meansthenumber,letterortheircombinationgivenperthebatchorthelotsoastoidentifyallthecompletehistoryoftheproductioncontrolanddistribution.23)Majorprocessormajormachineryorequipment24)“Cleanarea”meansanareawithdefinedenvironmentcontrolofintroductionofparticulatesandmicrobialcontaminationtomaintainthemunderacertaindegree.25)“Cleanlinessgrade”isacontrolledlevelofcleanlinessofcleanareatobemaintained.2.PremiseMaintenance&EnvironmentControl2.1.PremiseMaintenanceAmanufacturerofpharmaceuticalsshouldmaketheconcernedmanufactorysuitabletothestandardsordainedbytheFacilitiesStandardMandateforPharmacy,Manufacture,ImporterandDealerofDrugs,andmaintainthemanufactoryproperlybyregularchecksaccordingtotheprovisionsofthefollowingitemssoastohavenotroubleintheproductionandqualitycontrol.1)Machinesorequipmentsofaworkplaceshouldbelaidoutinaordercorrespondingtothesequenceoftheoperations.2)Majormachinesorequipmentsformanufacturingshouldbelabeledwithnumbersorcodestobedistinguishedfromeachotherandproductname,batchnumberandthedateofuseshouldberecordedwhenthemachinesorequipmentswereused.3)Requiredamountandqualityofwaterusedinthemanufactureshouldbesecured.4)Pipeworkshouldbeclearlylabelledtoindicatethecontentsandthedirectionofflow.5)Itshouldbecontrolledthatlubricants,coolantsoretcdonotaffectthequalityofdrugproduct.6)Sewerinworkplaceshouldbedesignedtoavoidrefluxandbesterilizedonaregularbasis.7)Machinesorequipmentswhicharenotusedduetooutoforderandetc.,shouldberemovedfromproductionareas,orbeclearlylabeledasdefective.8)Qualificationevaluationshouldbeperformedformajormachineryandequipmentswhichareusedfornon-steriledrugproductexceptherbalmedicinesordrugsforclinicaltrials.2.2.ControlofAutomatedSystem1)Ifautomatedequipments(includingcomputerizedsystem)formanufacturingandqualitycontrolareusedthesystemsshouldberegularlycalibratedandthefunctionsshouldbecheckedupandrecordedonaregularbasis.2)Recordsofautomatedequipmentsshouldbechangedonlybyanauthorizedpersonandbecontrolledproperly.3