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BRIEFING〈1664〉AssessmentofDrugProductLeachablesAssociatedwithPharmaceuticalPackagingDeliverySystems.Inthe2010–2015cycle,thePackaging,Storage,andDistributionExpertCommitteedeterminedtheneedtoupdategeneralchaptersthatspeaktothequalityofthepackagingsystemsusedtostoredrugproducts.TheExpertCommitteesinitialfocuswasonthefinalpackagingsystems;however,ithadbeenextendedtoincludepackagingsystemscomponentsandtheirmaterialsofconstruction.Thesuitabilityofapharmaceuticalpackagingsystemforadrugproductcanbeassessedbyextractablesandleachablestesting.Outofthesecharacterizationstudies,specificcontrolsforapackagingsystem,itscomponents,oritsmaterialsofconstructioncanbeestablished.ThesuiteofgeneralchaptersforpackagingsystemsbeginswithPlasticPackagingSystemsandTheirMaterialsofConstruction661.1,whichisusedtocharacterizethematerialsofconstruction,andPlasticPackagingSystems661.2,whichisusedtocharacterizethefinalpackagingsystemand/orcomponent.OtherchaptersthatwillbeproposedinthefuturetoaddressthecharacterizationofplasticmaterialsusedinthemanufacturingprocessandmedicaldevicesarePlasticSystemsUsedforManufacturingPharmaceuticalProducts661.3andPlasticMedicalDevicesUsedtoDeliverorAdministerPharmaceuticalProducts661.4.Aspartofthiscontinuation,thePackaging,Storage,andDistributionExpertCommitteeisproposingAssessmentofDrugProductLeachablesAssociatedwithPharmaceuticalPackaging/DeliverySystems1664,whichpresentsaframeworkforthedesign,justification,andexecutionofaleachablesassessmentforpharmaceuticalpackaginganddeliverysystems.AworkshopwillbeheldDecember9and10,2013,atUSPheadquartersinRockville,MD,todiscusscommentsonthesuiteofpackaginggeneralchaptersandpotentialfuturerevisions.(GCPS:D.Hunt.)CorrespondenceNumber—C126513Addthefollowing:▪1664ASSESSMENTOFDRUGPRODUCTLEACHABLESASSOCIATEDWITHPHARMACEUTICALPACKAGING/DELIVERYSYSTEMSPURPOSEThisgeneralchapterpresentsaframeworkforthedesign,justification,andimplementationofassessmentsfordrugproductleachablesderivedfrompharmaceuticalpackaginganddeliverysystems.Ascientificallysoundleachablesassessmentisimportanttomanufacturersandtheirvarioussuppliersprimarilyasameansofestablishingthesuitabilityforuseofpharmaceuticalpackaging/deliverysystems,asleachablescanpotentiallyaffectdrugproductefficacy,safety,andquality.Additionally,suchaleachablesassessmentcouldprovideanunderstandingofthesourcesofleachablesandhowtoevaluateandmanageleachablesduringthedrugdevelopmentandmanufacturingprocesses.Thechapterestablishescriticaldimensionsofaleachablesassessmentanddiscussespracticalandtechnicalaspectsofeachdimension.Thechapterdoesnotestablishspecificanalyticalmethodsorleachablesspecificationsandacceptancecriteriaforanyparticulardosageformorpackagingsystemanddrugproductcombination;nordoesitdelineateeverysituationinwhichaleachablesassessmentisrequired.Itisnotpossibleforageneraldiscussionofdrugproductleachablestoanticipateandcoverallsituationswhichcanoccurinthepharmaceuticalindustrywherealeachablesassessmentmightberequired.Designinganindividualleachablesassessmentisaprocessthatstrikesabalancebetweensoundscience,prudentresourceallocation,andeffectiveriskmanagementwithanemphasisonpatientsafety.Achievingthisbalanceistheresponsibilityandobligationofthedrugproductmanufacturer,andassumesdueconsiderationofapplicablelegalandregulatoryrequirements.Theprinciplesandbestdemonstratedpracticesoutlinedinthisgeneralchapterrepresentaconsensusinterpretationofsoundscienceandcanthereforebeextrapolatedandappliedtoanysituationinwhichaleachablesassessmentisrequiredforpharmaceuticalapplication.Inmanycases,drugproductleachablesassessmentsarebasedonorfacilitatedbyknowledgefromextractablesassessmentsaccomplishedondrugproductpackagingsystems,packagingcomponents,andpackagingmaterialsofconstruction(seeAssessmentofExtractablesAssociatedwithPharmaceuticalPackaging/DeliverySystems1663).KEYTERMSThisgeneralchapterusesthefollowingkeyterms(1,2;alsoseePackagingandStorageRequirements659).NotethatthetermsPackagingSystem,PackagingComponent,PrimaryPackagingComponent,SecondaryPackagingComponent,andMaterialsofConstructionarealsodefinedin659,andthedefinitionsbelowareintendedforclarificationpurposeswithinthecontextofthischapterandarenotintendedtosupersedethoseprovidedin659.PackagingSystemsarethesumofpackagingcomponentsthattogethercontain,protect,andincertaincasesdeliverthedosageform.PackagingsystemsarealsoreferredtoasContainerClosureSystems.PackagingComponentsaresinglepartsofapackagingsystem.Eachindividualpackagingcomponenthasaparticularfunctionwithinthecontextofcontaining,protecting,anddeliveringthedosageform.AnindividualpackagingcomponentcanbePrimary,meaningthatitisormaybeindirectcontactwiththedosageform(e.g.,aninhalationsolutionplasticnebule);orSecondary,meaningthatitisnotorwillnotbeindirectcontactwiththedosageformbutmayprovideadditionalprotection(e.g.,aninhalationsolutionfoiloverwrappouch).PackagingcomponentsareconsideredtobeTertiaryiftheyarenotindirectcontactwiththedosageformbutfacilitatehandlingandtransportinordertopreventdamagefromphysicalhandlingandstorageconditionstowhi