USP 1079 Good Storage and Distribution Practices f

5656〈1079〉GoodStorageandDistributionPractices/GeneralInformationSecondSupplementtoUSP35–NF30GeneralChaptersGeneralInformationenvironmentalaspects(suchastemperature,humidity,Changetoread:and/orotherenvironmentalfactors)forthedrugproductandensuresthatadequateprocessestomaintainthatenvironmentareinplace.〈1079〉■GOODSTORAGEANDHazardousmaterialsand/ordangerousgoods:Anyitemorchemicalwhich,whenbeingtransportedorDISTRIBUTIONPRACTICESFORmoved,isarisktopublicsafetyortheenvironment,andisregulatedassuchunderanyofthefollowing:Hazard-DRUGPRODUCTSousMaterialsRegulations(49CFR100–180);Interna-tionalMaritimeDangerousGoodsCode;DangerousGoodsRegulationsoftheInternationalAirTransportAs-sociation;TechnicalInstructionsoftheInternationalCivilAviationOrganization;ortheU.S.AirForceJointManual,INTRODUCTIONPreparingHazardousMaterialsforMilitaryAirShipments.InternationalConferenceonHarmonization(ICH)ThisgeneralinformationchapterdescribesgoodstorageGuidanceforIndustry,Q10PharmaceuticalQualitySys-anddistributionpracticestoensurethatdrugproductstem;ICHQ9,QualityRiskManagement;and,ICHQ1AR2,(medicines)reachtheenduser(practitionersandpatient/StabilityTestingofNewDrugSubstancesandProducts:consumers)withqualityintact.InternationallyharmonizeddocumentsintendedtoassistInthecontextofthischapter,thefollowingdefinitionsthepharmaceuticalindustry.areused.MeanKineticTemperature(MKT):Thesinglecalcu-latedtemperatureatwhichthetotalamountofdegrada-tionoveraparticularperiodisequaltothesumoftheDefinitionsindividualdegradationsthatwouldoccuratvarioustem-peratures.Adulteration:FDAFDCAct,SEC.501(351),AdrugPreventiveactions:Themeasurestoeliminatetheordeviceshallbedeemedtobeadulterated,if(2)(A)Itcauseofapotentialnonconformityorotherundesirablehasbeenprepared,packed,orheldunderinsanitarypotentialsituation.conditionsitmayhavebeencontaminatedwithfilth,orQuality:Thephysical,chemical,microbiological,bio-wherebyitmayhavebeenrenderedinjurioustohealth;logical,bioavailability,andstabilityattributesthatadrugor(B)themethodsusedin,orthefacilitiesorcontrolsproductshouldmaintaininordertobedeemedsuitableusedfor,itsmanufacture,processing,packing,orhold-fortherapeuticordiagnosticuse.Inthischapter,theingdonotconformtoorarenotoperatedoradminis-termisalsounderstoodtoconveythepropertiesofteredinconformitywithcurrentgoodmanufacturingsafety,identity,strength,quality,andpurity.practicetoassurethatsuchdrugmeetstherequirementsQualityManagementSystem(QMS):InthecontextofthisActastosafetyandhastheidentifyandstrength,ofthischapter,minimallyasetofpolicies,processes,andmeetsthequalityandpuritycharacteristics,whichitandproceduresthatenabletheidentification,measure-purportsorisrepresentedtopossess.ment,control,andimprovementofthedistributionandContinuousimprovement:Recurringactivitytoin-storageofdrugproduct.Itisthemanagementsystemcreasetheabilitytofulfillrequirements(seeQualityMan-usedtodirectandcontrolacompanywithregardtoagementSystems—FundamentalsandVocabulary.ISOquality(seeICHQ10modelandQualitySystem—Funda-Standard9000:2005).mentalsandVocabulary,ISOStandard9000:2005).Distribution:ReferstoelementssuchasshippingandRiskManagementSystem:Asystematicprocessusedtransportationactivitiesthatareassociatedwiththetoassess,control,communicate,andreviewriskstothemovementandsupplyofdrugproducts.qualityofadrugproductacrosstheproductlifecycle.DistributionManagementSystem:AprogramthatIntegraltoaneffectivepharmaceuticalqualitysystem,itcoversthemovement,includingstorageandtransporta-isasystematicandproactiveapproachtoidentifying,sci-tion,ofdrugproducts.entificallyevaluating,andcontrollingpotentialriskstoDocumentation:Recordedinformation.qualityasdescribedinICHQ10.ItfacilitatescontinualDrugproducts:Medicines,includingmarketedhumanimprovementofprocessperformanceandproductqual-andveterinaryprescriptionfinisheddosagemedications,itythroughouttheproductlifecycle.ICHQ9QualityRiskin-process/intermediate/bulkmaterials,drugproductManagementprovidesprinciplesandexamplesoftoolssamples,clinicaltrialmaterials,over-the-counterproductsthatcanbeappliedtodifferentaspectsofpharmaceuti-(OTC).calquality.Enduser:Thepatientaswellasthehealthcarepro-WrittenAgreementorContract(commonlyreferredvideradministeringthedrugproducttothepatient.toasaQualityAgreement,TechnicalAgreement,Ser-EnvironmentalManagementSystem:AmanagementviceLevelAgreement,orother):Anegotiated,docu-systemthatallowsfortheidentificationofqualitycriticalmentedagreementbetweenthedrugproductownerOfficialfromDecember1,2012Copyright(c)2013TheUnitedStatesPharmacopeialConvention.Allrightsreserved.Accessedfrom173.161.163.105byrichmondtrialonMonJan1413:46:21EST2013SecondSupplementtoUSP35–NF30GeneralInformation/〈1079〉GoodStorageandDistributionPractices5657andserviceproviderthatdefinesthecommonunder-Thisgeneralinformationchapterdoesnotsupersedeorstandingaboutmaterialsorservice,qualityspecifications,supplantanyapplicablenational,federal,and/orstatestor-responsibilities,guarantees,andcommunicationmecha-ageanddistributionrequirements,orUSPmonographs.Thenisms.Itcanbeeitherlegallybindingo