FDA最新指导原则：药物分析程序及方法验证指导原则

GuidanceforIndustryAnalyticalProceduresandMethodsValidationforDrugsandBiologicsDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin90daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)LucindaBuhse314-539-2134,or(CBER)OfficeofCommunication,OutreachandDevelopmentat800-835-4709or301-827-1800.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)February2014CMCGuidanceforIndustryAnalyticalProceduresandMethodsValidationforDrugsandBiologicsAdditionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.,SilverSpring,MD20993Phone:[phone];Fax:[e-mail]@fda.hhs.gov(Tel)800-835-4709or301-827-1800U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)February2014CMCContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.ANALYTICALMETHODSDEVELOPMENT............................................................3IV.CONTENTOFANALYTICALPROCEDURES..........................................................3A.Principle/Scope............................................................................................................4B.Apparatus/Equipment................................................................................................4C.OperatingParameters................................................................................................4D.Reagents/Standards....................................................................................................4E.SamplePreparation....................................................................................................4F.StandardsControlSolutionPreparation..................................................................5G.Procedure.....................................................................................................................5H.SystemSuitability........................................................................................................5I.Calculations.................................................................................................................5J.DataReporting............................................................................................................5V.REFERENCESTANDARDSANDMATERIALS........................................................6VI.ANALYTICALMETHODVALIDATIONFORNDA,ANDAs,BLAs,ANDDMFs.............................................................................................................................................6A.NoncompendialAnalyticalProcedures.....................................................................6B.ValidationCharacteristics..........................................................................................7C.CompendialAnalyticalProcedures...........................................................................8VII.STATISTICALANALYSISANDMODELS................................................................8A.Statistics.......................................................................................................................8B.Models..........................................................................................................................8VIII.LIFECYCLEMANAGEMENTOFANALYTICALPROCEDURES......................9A.Revalidation.................................................................................................................9B.AnalyticalMethodComparabilityStudies.............................................................101.AlternativeAnalyticalProcedures........................................................................102.AnalyticalMethodsTransferStudies..........................................