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1、PostApprovalChangesforFinishedProductLinHong1AAPS/CPAWorkshop,June28-29,2010DisclaimerTheinformationcontainedinthepresentationhasbeencompiledfromvarioussources.Theviewsandopinionsexpressedarethoseoftheindividualpresenterandshouldnotbeattributedtoanyorganiza
2、tionwithwhichthepresenterisemployedoraffiliated.2AAPS/CPAWorkshop,June28-29,2010PostApprovalChangesGuidelineDocumentsUS:SUPAC:IR(1995),MR(1997)SUPAC:IR/MREquipmentGuidance(1999)SUPAC:ExtendedreleaseOralSolidDosageForms,Development,EvaluationandApplicationof
3、In-Vitro/In-VivoCorrelation(1997)ChangestoanApprovedNDAorANDA(2004)3AAPS/CPAWorkshop,June28-29,2010PostApprovalChangesGuidelineDocumentsEU:CommissionRegulation(EC)No726/2004CommissionRegulation(EC)No1234/2008CommissionRegulation(EC)No1084(5)/2003ModifiedRel
4、easeOralandTransdermalDosageForms:SectionsIandIICPMP/QWP/604/96,CPMP/EWP/280/96GuidelineontheInvestigationofBioequivalenceCPMP/EWP/QWP/1401/984AAPS/CPAWorkshop,June28-29,2010UnitedStatesTheguidelinesprovidedetailsofthe…TypeofchangeLevelsofchangeCMCdocumenta
5、tionrequiredtosupportthechange(dissolutionand/orbioequivalencetests,analyticaltesting….)Filingrequirements5AAPS/CPAWorkshop,June28-29,2010UnitedStatesMinorChange(Level1):MinimalpotentialtohaveanadverseeffectAnnualreport(AR)ModerateChange(Level2):Moderatepot
6、entialtohaveanadverseeffectChangesBeingEffected(CBE)ChangesBeingEffected30days(CBE-30)MajorChange(Level3):SubstantialpotentialtohaveanadverseeffectPriorApprovalSupplement(PAS)6AAPS/CPAWorkshop,June28-29,2010UnitedStatesToIndustry:Responsibilitytoclassifycha
7、ngemovedfromFDAtoindustryAllowsmorechangeswithoutpriorFDAapprovalUseofnewtechnologiesManufacturingcostreductionAdequacyofthestudiesmaybequestionedmonthsoryearslaterevenifthechangesarepredictedorapprovedIfthevalidityofAR/CBE/CBE-30changesischallengedthespons
8、ormayberequiredtotracktheaffectedlots/batchesandprovideadditionaldata,quarantineorrecallproductifitisneededGreaterliabilityifthechangeisnotadequatelysupported7AAPS/CPAWorkshop,June28-29,2010EuropeanUni
