文档介绍：RegulatoryAssessmentDisclaimerTheinformationwithinthispresentationisbasedontheICHQ-IWGmembersexpertiseandexperience,andrepresentstheviewsoftheICHQ- andRealTimeReleaseTestingAssessors-ordingtonewparadigmPrinciplesofAssessmentAssessmentprinciplesarethesameregardlessofthedevelopmentapproachMeetQualityTargetProductProfiles(QTPPs)Areasofassessment:APIFormulationManufacturingprocessControlstrategyAnalyticalProceduresStabilityRegulatoryAssessment APIandFormulationAPIGeneralConsiderationsQbDprinciplesapplytoAPIsQbDprinciplescanguidemanufacturingprocessdesignandcontrolstrategydevelopmentDesignspacecanbedevelopedforAPIprocessesAPI-Assessors’EvaluationHavestartingmaterialsandprocessbeenadequatelydescribed?Aretheretoxicityconcernswithdegradantsand/orrelatedsubstances?Haveadequatespecificationsandmethodsbeenproposed?Haveadequateprocesscontrolsbeendescribed?Wasthedesignspaceadequatelydevelopedanddataprovidedtosupportit?Formulation-GeneralConsiderationsDesignspace–ponentattributesBasedoninputrawmaterialattributesLottolotvariabilityJustifiedbydata(Priorknowledge,DoE,etc),PK,stability,patibilityAssessors’EvaluationoftheFormulationIsdosageformdesignedtomeetQTPP?Aretherolesofingredientsidentified?patibilityofingredientsbeenadequatelyaddressed?Istheformulationadequatelyunderstoodandspecified?Doestheproposedformulationdifferfromtheformulationusedinthepivotalclinicaltrials?