Designation:E2891−13StandardGuideforMultivariateDataAnalysisinPharmaceuticalDevelopmentandManufacturingApplications1ThisstandardisissuedunderthefixeddesignationE2891;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidecoverstheapplicationsofmultivariatedataanalysis(MVDA)tosupportpharmaceuticaldevelopmentandmanufacturingactivities.MVDAisoneofthekeyenablersforprocessunderstandinganddecisionmakinginpharmaceuticaldevelopment,andforthereleaseofintermediateandfinalproducts.1.2ThescopeofthisguideistoprovidegeneralguidelinesontheapplicationofMVDAinthepharmaceuticalindustry.WhileMVDAreferstotypicalempiricaldataanalysis,thescopeislimitedtoprovidingahighlevelguidanceandnotintendedtoprovideapplication-specificdataanalysisproce-dures.Thisguideprovidesconsiderationsonthefollowingaspects:1.2.1Useofarisk-basedapproach(understandingtheobjectiverequirementsandassessingthefit-for-usestatus),1.2.2ConsiderationsonthedatacollectionanddiagnosticsusedforMVDA(includingdatapreprocessingandoutliers),1.2.3Considerationsonthedifferenttypesofdataanalysisandmodelvalidation,1.2.4Qualifiedandcompetentpersonnel,and1.2.5Life-cyclemanagementofMVDA.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2C1174PracticeforPredictionoftheLong-TermBehaviorofMaterials,IncludingWasteForms,UsedinEngineeredBarrierSystems(EBS)forGeologicalDisposalofHigh-LevelRadioactiveWasteE178PracticeforDealingWithOutlyingObservationsE1355GuideforEvaluatingthePredictiveCapabilityofDeterministicFireModelsE1655PracticesforInfraredMultivariateQuantitativeAnalysisE1790PracticeforNearInf...
