3/8/2014 Automating Labeling Processes - Contract Pharma

http://www.contractpharma.com/issues/20131101/view_features/automating-labeling-processes/ 1/3
AutomatingLabelingProcesses
Aglobalbusinessmodeltoensurecomplianceandaccuracyin
anincreasinglycomplexenvironment
ByChitraLeleandBinduNarang,SciformixCorporation
Whilepharmaceuticalinnovatorsstreamlineoperationsinthedevelopedregions,significantinvestmentisbeing
pouredintoemergingmarketstofuelgrowth,specificallybymanufacturersofgenerics,asmorepharma
productsgooffpatent.Itisestimatedthatgenericcompetitioneroded$67billionfromtopdrugcompanies
annualsalesintheU.S.between2007and2012,withmorethanthreedozendrugslosingpatentprotection
duringthisperiod(DeRuiterandHolston,2012).EvaluatePharmas(2012)analysisshowsthatmorethan$290
billionofprescriptiondrugsalesareatriskfrompatentexpirationsbetween2011and2018.
Inresponsetothesepressures,theglobalpharmaindustryisexploringnewgrowthopportunitiesinemerging
markets,strengtheningR&Dbycollaboratingwithindustryandacademicpartners,movingtowardsamixed
portfolioofinnovativeandgenericproductsandfocusingonoperationalefficiency.Asaresult,eventhe
marketingoftheseproductsisbeingdrivenmorebypartnershipsbetweenmultiplecompanies.Therehasbeen
asubstantialincreaseinthenumberoflicensingandsupplypartnershipsbetweengenericsmanufacturers
basedinemergingmarketsandlargeormidsizedglobalpharmaceuticalcompanies.Indeed,itispredictedthat
Pharmergingwillberesponsibleformorethan50%ofthegrowthintheglobalpharmamarkets(Management
CentreEurope,2012).Apartfromthesharingofrisk,collaborationswithmanufacturersofgenericsallow
innovatorstoincreasetheirproductportfolioandensuretheireconomicviability.
Thisglobalexpansionacrossdifferentgeographieshasledtodecentralizationthatcan,inmanycases,slow
downcomplexprocessesandreduceoperationalefficiencyandprofitability,whiledelayingtimetomarket.
Furthermore,theneedforgreaterqualitycheckstoensurebrandintegrityisparamountintheglobal
marketplaceinordertocomplywithlocalregulatorymandatesandtomanagetheresourcesthatarespread
acrossmultiplegeographies.
Productlabelingisonesuchprocessaffectedinmaintainingacompanywidequalitysystemwithinaglobal
businessmodel.Productlabelsareanessentialpartofthemarketedproductastheyprovidecomprehensive
informationaboutthedrug,andalsorepresentasignificantpercentageofthemanufacturingcostand
commercializationriskintermsofensuringpatientsafety.Withinnovatorsundertakingmanufacturingin
emergingcountries,conductingqualitychecksinanothercountryandmarketingtheproductinathirdcountry,
thebusinessmodelhasgrowntosuchdimensionsthatithasbecomeextremelycomplextomaintaina
companywidequalitysystemthatstandardizesproductlabelingprocessesglobally.
RegulatoryChallenges
Pharmaceuticalproductlabelingisahighlyregulatedandcomplexprocessthatisanintegralpartofa
companysoverallqualitysystem.Itincludesvitalinformationrelatedtotheproduct:thedrugsname,the
manufacturersnameandaddress,anidentificationcode,lotnumber,activeandinactiveingredients,quantityof
productinthecontainer,indications,safetyinformation,usageinstructions,storageconditions,andan
expirationdate.Aproductwithawidegeographicalfootprintrequireslabelsineachcountry/regiontocomply
withtherequirementsoflocalregulatoryagencies.Thisincreasestheriskofhavinginconsistentinformation
acrosslabelsofthesameproduct.
Ensuringthatlabelingprocessesarestandardizedandupdatedinaccordancewithregulatoryupdatesisa
challengeforbothpharmainnovatorsandmanufacturersofgenerics.Thishasbeenhighlightedintherecent
plansannouncedbytheU.S.FDAtoestablishsimilarlabelingguidelinesforgenericsandbrandeddrug
manufacturers,whichwillfurtherincreasetheregulatorychallengeforgenericscompanies(Reuters,2013)
(Reginfo,2013).Asitstands,manufacturersofgenericsarepreventedfromupdatingtheirlabelsforpotential
safetyissueswithoutspecialFDAapproval,althoughbrandeddrugmanufacturerscan.Afterthelawcomesinto
practice,genericsmanufacturerswillbeallowedtoupdatelabelsbasedonnewsafetyinformation.
Manufacturersofgenericsrunthesamerisksastheinnovatorsandthereforefaceunlimitedliabilityifthelabels
ontheirproductsfailtoincludevitalinformationoriftheirproductscauseanyinjurytoaconsumer(Forbes
2013).Ensuringlabelaccuracyandtheimplementationofassociatedqualitycontrolswithsuppliersand
distributors,togetherwithregulatorycomplianceacrossregionsthathavevaryingregulatoryrequirements,are
thereforeamongtheprimeconcernsforanypharmacompany.
TheLabelingProcess
Productlabelingisacollaborativeprocess,frominitiationofaclinicaltrialtocommercialization,withmultiple
sourcesofinputsandhandoffsthatultimatelyresultinaninternalreferencedocumentknownastheCompany
CoreDataSheet(CCDS).TheCCDSincludesalltherelevantinformationontheproducttobelabeled,andis
usedtomaplabelinginformationfordifferentregions.EveryCCDSmayrequiremultiplechangesdependingon
themarketswherethedrugisapprovedandsold.Complexitiesincreasewhilemanagingregionaldocuments
becausetheapproachneedstoaccommodatelocalregulatoryrequirements,languages,writingstyles,and
conventions.Theissueisfurthercompoundedwhentheseregionaladaptationsneedtobeupdatedwhenever
thereisachangeinthemasterCCDSfrequentchangesinregulatoryrequirementsandthenumberofhandoffs
maketheprocessevenmorecomplex.
Formostorganizations,theprimaryprocessesinvolvedindevelopingaproductlabelaremanual,labor
intensive,andpronetocostlymistakes.Moreover,theprocessesaretimeconsuming,asmultiplestakeholders
suchasmedical,regulatory,legal,manufacturing,andqualityspecialistsneedtobeinvolvedineachlabel
update.Forexample,updatestotheprescribinginformationofaproduct,changestothemanufacturing
processesandnewsideeffects,needtobeincludedinthelabel.Theprocessofcreatingtheupdatestothe
prescribinginformationislaborintensive,asthechangesmustbereviewedandtranscribedintodifferent
formats(e.g.leafletsandartwork).Eachversionoftheproductlabelrequiresitsownartwork,andsignificant
resourcesarerequiredforproofreadingandvalidatingartworkfilestoensurethattheprintedlabeliserrorfree.
Havingaportfolioofproductsdistributedacrossmultipleregionswiththeassociatedrequirementtocomplywith
theregulationsofmultipleagenciesincreasesthiscomplexityandthereforealsoincreasesthecost
exponentially.
DriversforLabelingAutomation
Currently,organizationsdevelopstandardoperatingprocedures(SOPs)tostreamlineoperationsandminimize
errorshowevertheyoftenlacktheautomationrequiredtobuildarobustanderrorfreeprocess.Whiletheuseof
anautomatedprocesscanreducecycletimeandcosts,theprimarydriversforitsusearelabelaccuracyand
quality.Errorfreedatasubmittedtoregulatoryagenciesduringtheapprovalprocesspriortoaproductsrelease
3/8/2014 Automating Labeling Processes - Contract Pharma
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tomarketiscriticalforitssuccess.Thereisalsosignificantmotivationtoshavetimetomarketwhileholding
theintegrityoftheproductandtheassociatedprocesscosts.
Failuretoensurethesekeyrequisitesoflabelaccuracyandqualitycanleadtolabelingerrorsthatarehighly
visibleandcanseriouslydamagethereputationofapharmacompany.Labelingerrors,mixupsand
misbrandingareamongthemostprevalentlabelingerrorsthatcanleadtoproductrecalls.Theresultscanbe
cripplingtoanorganizationintermsoflossofrevenueandmarketshare,aswellasnegativepublicitythatcan
severelytarnishacompanysimage.Researchhashighlightedthatacompanysstockpricedeclinesupto22%
withintwoweeksafterarecallisannounced(RapidRecallExchange,2010).
Recentproductrecallsbymajorpharmaceuticalcompanieshavehighlightedthisthreat.In2013,VitaHealth
ProductsInc.voluntarilyrecalledavarietyofhealthproductsfromtheCanadianmarketbecauseoflabeling
issues(HealthCanada,2013).Therecalledproductsposearisktohealthbecausethelabelscontainerrors
suchassuggestingpackagesarechildresistantwhentheyarenot,oraremissingwarningstatementsfor
consumerswithallergiesorexistingmedicalconditions.
Giventheselabelingrisks,pharmacompaniesarecontinuouslylookingatmakingfundamentalchangestotheir
operationstoadapttothegrowingcomplexity,minimiseriskandimproveefficiencyofthelabelingprocess.
However,managingtheendtoendprocess,suchasmultilanguagetranslationoflabels,maynotbeacore
competencyformanycompanies,nordothemajorityhavetheexpertisetohandletheissuesinhouse.Inorder
tofocusontheircoreexpertiseofdeliveringnewproductstomarket,innovatorsandgenericmanufacturerscan
looktooutsourcetheactivityofupdatinglabelstoapartnerwiththerequiredexpertise,processes,andtoolsto
improvetheaccuracyandqualityoflabels.
MeetingtheChallengeswithLabelingAutomation
Byoutsourcinggloballabelingoperationstospecializedvendors,innovatorsandgenericmanufacturersareable
toaccessmanagedservicesspanningCommercializationtoAdverseEventLabelingprocesses(CAEL).
VendorsthatimplementinnovativetoolsandLEANprocessesaddresstheaforementionedlabelingchallenges
byprovidingautomatedtextcomparison,contentmanagement,andworkflowmanagement.Automationreduces
humaninterventionandensuresthedevelopmentofhighqualitydeliverablesthatsignificantlyreduceoverall
operationalcostsandimprovethetimetomarketacrossorganizationalproductlines.
AnexampleofautomationisupdatingtheregionallabelingdocumentsfromthemasterCCDS.Inordertofind
andimplementupdatesindifferentformatsandlanguages,organizationsutilizekeyresourcestofirstmakea
sidebysidecomparisonofthetwodocuments,andthenupdatethelocallabel.Thisisbothlaborintensiveand
errorprone.Byimplementingautomationtools,differencesareautomaticallyhighlightedbetweenthe
documents,significantlyreducingoperationalcosts,andimprovingqualityandtimetomarketduetothesteep
reductionofhumanintervention.Inthecaseofgenericproducts,wheretheupdateofgenericlabelsbasedon
theReferenceListedDrug(RLD)mightrequirethecomparisonofanumberofpagesandmultiplevoluminous
tables,significanttimeandlaborinvestmentsareneeded.Manualinterventioncontributestoqualityissues.
Autogenerationofacomparisontableusingvarioussourcedocuments(genericlabel,RLDlabelandgeneric
proposedlabel)isextremelyhelpfulinsavingsignificantamountsoftimeanddevelopingerrorfreeupdated
labelsandchangelogs.Implementingastreamlinedworkflowmanagementprocess,alongwithadocument
managementsystemthatstandardizeslabelandartworkcontentandallowsforversioncontrol,increases
accuracyasitsynchronizescontentandversionsacrossglobalgeographies.
Duetothehighdemandsofregulatorycompliance,accuratelabelingofpharmaceuticalproductshasbecomea
criticalsafetymatter.Lackofeffectivecontrolmeasuresandprocessestoeliminatelabelingerrorscouldresult
inserioushealthhazards,regulatoryactions,andatarnishedreputationforapharmacompany.
Inconjunctionwithcompliancetotherequirementsofmultipleregulatoryagencies,thereisapressingneedto
addressthechallengeofensuringcontentconsistencyacrossabroadportfolioofproductsacrossmultiple
regions.Theissueofmanaginglargelabelingdocuments,multilingualinformationandeffectivetranslation
managementhasforcedbothpharmainnovatorsandgenericmanufacturerstoviewthelabelingprocessfroma
differentperspective.Withsuchactivitiesnotattheircore,thesecompaniesarenowturningtoexternalpartners
equippedwiththelatestLEANandautomationservicestoaddressthechallengesassociatedwiththegrowing
complexityofthelabelingprocess.
Basedonourexperiences,pharmaceuticalinnovatorsandmanufacturersofgenericscanbenefitthroughthe
attainmentofareductioninapprovalcycletimesof50%+,errorreductionby95%+,andanoverallcost
reductionof45%+figuresthatrepresentclearfinancialbenefits.Theautomatedprocessesproduceconsistent
andqualitydocumentationthatpromotestheaccuracyrequiredtomaintainpatientsafetyaswellasbrand
integrity.Withareductioninmanualinterventionsof60%+,changescanbemanagedmuchmorequickly,
savingsignificantamountsoftimeforpharmacompanies.
Withthepharmaindustryaddressingthechallengeofdiverselanguagesinemergingmarketswhilereducing
costsandcomplyingwithmultipleregulatoryagencies,thereisacompellingneedforautomatinglabeling
processestoreduceriskbyensuringgreatercontentconsistencyacrossabroadrangeofproducts.
References
DeRuiter,J.andHolston,P.L.(2012).Drugpatentexpirationsandthepatentcliff.U.S.Pharm37(6)(Generic
suppl):pp.1220.
EvaluatePharma(2012).Patentexpirationsputmorethan$290billioninprescriptiondrugsalesatriskthrough
2018.Availableathttp://www.evaluategroup.com/public/PressReleases/PatentExpirationsPutMoreThan
$290BillioninPrescriptionDrugSalesatRiskThrough2018.aspxAccessed5/20/13
Forbes(2013).GenericDrugMakersWillSoonFaceTheRegulatoryMusic.Availableat
http://www.forbes.com/sites/richardlevick/2013/07/15/genericdrugmakerswillsoonfacetheregulatorymusic/
Accessed10/2/13
HealthCanada(2013):VitaHealthrecallsnumerousOverthecounterproductsbecauseoflabellingerrors.
Availableathttp://healthycanadians.gc.ca/recallalertrappelavis/hcsc/2013/35525aeng.phpAccessed
10/20/13
ManagementCentreEurope(2012).NewOpportunities&StrategiesinthePharmaceuticalIndustry.Available
athttp://www.mceama.com/executiveissue38pharmaindustry2012/Accessed10/3/13
RapidRecallExchange(2010).Patentexpirationsputmorethan$290billioninprescriptiondrugsalesatrisk
through2018.Availableathttp://www.rapidrecallexchange.org/LinkClick.aspx?
fileticket=6o5DhktwSe8%3D&tabid=37Accessed9/30/13
Reuters(2013).U.S.FDAtoproposeallowinggenericdrugmakerstoupdatedruglabels.Availableat
http://www.reuters.com/article/2013/07/03/fdagenericsidUSL2N0F92B320130703Accessed10/20/13
Reginfo(2013).ViewruleSupplementalApplicationsProposingLabelingChangesforApprovedDrugsand
BiologicalProducts.Availableathttp://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201304&RIN=0910
AG94Accessed10/20/13
ChitraLele,Ph.D.ischiefscientificofficer,SciformixCorporation.BinduNarangisdirectorregulatoryaffairs
3/8/2014 Automating Labeling Processes - Contract Pharma
http://www.contractpharma.com/issues/20131101/view_features/automating-labeling-processes/ 3/3
Copyright2014RodmanMedia.AllRightsReserved.Allrightsreserved.UseofthisconstitutesacceptanceofourPrivacyPolicy
Thematerialonthissitemaynotbereproduced,distributed,transmitted,orotherwiseused,exceptwiththepriorwrittenpermissionofRodmanMedia.
andscientificwriting,SciformixCorporation.Copiesofthepharmaceuticalproductlabelingwhitepaperfrom
Sciformixareavailablebyemailingask@sciformix.com.Forfurtherpressinformation,pleasecontactDavid
Bertramatsciformix@scottpr.comorSusanNajjar,directorofmarketing,SciformixCorp.,at
susan.najjar@sciformix.com.
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