美国药典--优良仓储运输规范GOOD STORAGE AND SHIPPING PRACTICES

1079GOODSTORAGEANDSHIPPINGPRACTICES-GeneralChaptersUS.PharmacopoeiaUSP29Search1079GOODSTORAGEANDSHIPPINGPRACTICES-GeneralChapters1079GOODSTORAGEANDSHIPPINGPRACTICESThisgeneralinformationchapterisintendedtoprovidegeneralguidanceconcerningstoring,distributing,andshippingofPharmacopeialpreparations.Itdescribesprocedurestomaintainproperstorageenvironmentsforindividualarticlesandtoensureapreparation'sintegrity,includingitsappearance,untilitreachestheuser.ThereisnochangetoanyapplicablerequirementsunderCurrentGoodManufacturingPractices,approvedlabeling,statelawsgoverningpharmacies,theUSPGeneralNoticesandRequirements,ormonographs.ThesectionPreservation,Packaging,Storage,andLabelingunderGeneralNoticesandRequirementsprovidesdefinitionsforstorageconditions.Allequipmentusedforrecording,monitoring,andmaintainingtemperaturesandhumidityconditionsshouldbecalibratedonaregularbasis.ThiscalibrationshouldbebasedonNISTorinternationalstandards(seeMonitoringDevices—Time,Temperature,andHumidity1118).APharmacopeialpreparationmayfollowseveralpotentialroutesfromtheoriginalmanufacturertothepatient.Figure1documentspresent-dayroutesandtheassociatedrisks.Theserisksincludeexposuretotemperatureexcursions,humidity,light,andoxygen.Foradiscussionofclimates,stability,andmeankinetictemperature,seePharmaceuticalStability1150.Temperature-orhumidity-sensitivearticlesaretobehandledinaccordancewithGeneralNotices.PACKAGINGANDSTORAGESTATEMENTINMONOGRAPHSMostarticleshavestorageconditionsidentifiedbytheirlabeling.Otherwise,itisexpectedthattheconditionsforstoringthearticlearespecifiedinthemonographaccordingtodefinitionsprovidedbytheGeneralNoticesandRequirementsinthesectionStorageTemperature,andHumidityunderPreservation,Packaging,Storage,andLabeling.Incaseswhereadditionalinformationonpackagingandstorageisdesired,aspecificstatementcanbeprovidedinthePackagingandstorageortheLabelingsectionoftheindividualmonograph.STORAGEINWAREHOUSES,PHARMACIES,TRUCKS,SHIPPINGDOCKS,ANDOTHERLOCATIONSPharmacopeialarticlesaretobestoredinlocationsthatadheretoconditionsestablishedbythemanufacturer.Wherethedesiredconditionsarenotestablished,usestorageconditionsdescribedintheGeneralNoticesandRequirementsorintheapplicablemonograph.WarehousesObservationofthetemperaturevariationsinawarehouseshouldbemadeoveraperiodoftimetoestablishameaningfultemperatureprofile,includingthetemperaturevariationsandconditionsinthedifferentpartsofthewarehouse.Suchobservationsprovidedataandinformationastowherevariousproductsshouldandshouldnotbestored.ESTABLISHINGTEMPERATUREPROFILESTemperatureprofilescanbecompiledbyusingasuitablenumberofthermometersorothertemperaturerecordinginstruments.Theyshouldbeplacedthroughoutthewarehouseindividedsectionsandshouldrecordthemaximumandminimumtemperaturesduringa24-hourperiodforatotalofthreeconsecutive24-hourperiods.Thefollowingfactors,someofwhichmaygiverisetoextremetemperatures,shouldbeconsideredduringtheprocessoftemperatureprofiling:thesizeofthespace,locationofspaceheaters,sun-facingwalls,lowceilingsorroofs,andgeographiclocationofthewarehouse.Temperatureprofilingforwarehousesalreadyinuseshouldbedoneatknowntimesofexternaltemperatureextremes,e.g.,foraperiodofnotlessthan3hourswhenairtemperaturesarehigherthan25orlessthan15.Profilingshouldbeconductedinbothsummerandwinter.Ameankinetictemperature(MKT)shouldbeobtainedforanyseparateareaswithinthewarehouse(seePharmaceuticalCalculationsinPrescriptionCompounding1160forsamplesofMKTcalculations).ThetemperatureprofilereportshouldproviderecommendationsfortheuseofeachareaandidentificationofanyareasthatarefoundunsuitableforstorageofPharmacopeialarticles.CONTROLLEDROOMTEMPERATURETheGeneralNoticesprovideadefinitionforControlledRoomTemperature.AtemperatureprofilingstudyshoulddemonstratesuitabilityforstoringPharmacopeialarticlesinareasdeterminedtobeatroomorcontrolledroomtemperature.Asuitablenumberoftemperatureandhumidityrecordinginstrumentsshouldbeinstalledtorecordtemperaturesandtoprovidetemperatureandhumidityprofiles.Temperaturerecordingshouldbeconductedtomeettherecommendationsforestablishingmeankinetictemperatureandtocomplywiththewarehouse'swrittenprocedures.Thesewrittenproceduresshouldhaveareportingmechanisminplacewherebyamanagementtreeisinformedintheeventthatpredefinedhighorlowtemperaturesorhumiditylimitshavebeenexceeded.Recordscanbereviewedasdeterminedbythemanagementsysteminaccordancewithestablishedguidelines.Suitabletrainingshouldbeprovidedtopersonswhorecordtemperatures,andproperqualityaccountabilityandtrackingsystemsshouldbemaintained.STORAGEAT“COOL,”“COLD,”“REFRIGERATOR,”AND“FREEZING”CONDITIONSTheGeneralNoticesprovidedefinitionsforcool,cold,refrigerator,andfreezertemperatures.AtemperatureprofilingstudycanbeusedtoestablishsuitableareasforstoringPharmacopeialarticlesdesignatedtobestoredundertheseconditions.EquipmentusedforstoringPharmacopeialarticlesattheselowtemperaturesshouldbequalifiedaccordingtowrittenproceduresprovidedbythemanagementsystem.Recordingdevicescanbeinstalledwithintheequipmentandusedtoenablebothairandproducttemperatures