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INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINESTABILITYTESTING:PHOTOSTABILITYTESTINGOFNEWDRUGSUBSTANCESANDPRODUCTSQ1BCurrentStep4versiondated6November1996ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Q1BDocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q1BApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.28November1995Q1BCurrentStep4versionQ1BApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.6November1996Q1B2STABILITYTESTING:PHOTOSTABILITYTESTINGOFNEWDRUGSUBSTANCESANDPRODUCTSICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon6November1996,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHTABLEOFCONTENTS1.General......................................................................................................................1A.Preamble.............................................................................................................1B.LightSources......................................................................................................2C.Procedure............................................................................................................22.DrugSubstance.......................................................................................................4A.PresentationofSamples.....................................................................................4B.AnalysisofSamples............................................................................................5C.JudgementofResults.........................................................................................53.DrugProduct...........................................................................................................5A.PresentationofSamples.....................................................................................6B.AnalysisofSamples............................................................................................6C.JudgementofResults.........................................................................................64.Annex.........................................................................................................................7A.QuinineChemicalActinometry.........................................................................75.Glossary.....................................................................................................................86.References................................................................................................................8iSTABILITYTESTING:PHOTOSTABILITYTESTINGOFNEWDRUGSUBSTANCESANDPRODUCTS1.GENERALTheICHHarmonizedTripartiteGuidelinecoveringtheStabilityTestingofNewDrugSubstancesandProducts(hereafterreferredtoastheParentGuideline)notesthatlighttestingshouldbeanintegralpartofstresstesting.ThisdocumentisanannextotheParentGuidelineandaddressestherecommendationsforphotostabilitytesting.A.PreambleTheintrinsicphotostabilitycharacteristicsofnewdrugsubstancesandproductsshouldbeevaluatedtodemonstratethat,asappropriate,lightexposuredoesnotresultinunacceptablechange.Normally,photostabilitytestingiscarriedoutonasinglebatchofmaterialselectedasdescribedunderSelectionofBatchesintheParentGuideline.Undersomecircumstancesthesestudiesshouldberepeatedifcertainvariationsandchangesaremadetotheproduct(e.g.,formulation,packaging).Whetherthesestudiesshouldberepeateddependsonthephotostabilitycharacteristicsdeterminedatthetimeofinitialfilingandthetypeofvariationand/orchangemade.TheguidelineprimarilyaddressesthegenerationofphotostabilityinformationforsubmissioninRegistrationApplicationsfornewmolecularentitiesandassociateddrugproducts.Theguidelinedoesnotcoverthephotostabilityofdrugsafteradministration(i.e.underconditionsofuse)andthoseapplicationsnotcoveredbytheParentGuideline.Alternativeapproachesmaybeusediftheyarescientificallysoundandjustificationisprovided.Asystematicapproachtophotostabilitytestingisrecommendedcovering,asappropriate,studiessuchas:i)Testsonthedrugsubstance;ii)Testsontheexposeddrugproductoutsideoftheimmediatepack;andifnecessary;iii)Testsonthedrugproductintheimmediatepack;andifnecessary;iv)Testsonthedrugproductinthemarketingpack.TheextentofdrugproducttestingshouldbeestablishedbyassessingwhetherornotacceptablechangehasoccurredattheendofthelightexposuretestingasdescribedintheDecisionFlowChartforPhotostabilityTestingofDrugProducts.Acceptablechangeischangewithinlimitsjustifiedbytheapplicant.Theformallabelingrequirementsforphotolabiledrugsubstancesanddrugproductsareestablishedbynational/regionalrequirements.1PhotostabilityTestingofNewDrugSubstancesandProductsB