Understanding Pharmaceutical Quality by Design英文学习材料

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1、TheAAPSJournal,Vol.16,No.4,July2014(#2014)DOI:10.1208/s12248-014-9598-3ReviewArticleUnderstandingPharmaceuticalQualitybyDesign1,62133LawrenceX.Yu,GregoryAmidon,MansoorA.Khan,StephenW.Hoag,JamesPolli,4,51G.K.Raju,andJanetWoodcockReceived17November2013;accepted24March2014;publishedonline2

2、3May2014Abstract.Thisreviewfurtherclarifiestheconceptofpharmaceuticalqualitybydesign(QbD)anddescribesitsobjectives.QbDelementsincludethefollowing:(1)aqualitytargetproductprofile(QTPP)thatidentifiesthecriticalqualityattributes(CQAs)ofthedrugproduct;(2)productdesignandunderstandingincludingi

3、dentificationofcriticalmaterialattributes(CMAs);(3)processdesignandunderstandingincludingidentificationofcriticalprocessparameters(CPPs),linkingCMAsandCPPstoCQAs;(4)acontrolstrategythatincludesspecificationsforthedrugsubstance(s),excipient(s),anddrugproductaswellascontrolsforeachstepofthem

4、anufacturingprocess;and(5)processcapabilityandcontinualimprovement.QbDtoolsandstudiesincludepriorknowledge,riskassessment,mechanisticmodels,designofexperiments(DoE)anddataanalysis,andprocessanalyticaltechnology(PAT).Asthepharmaceuticalindustrymovestowardtheimplementationofpharmaceutical

5、QbD,acommonterminology,understandingofconceptsandexpectationsarenecessary.Thisunderstandingwillfacilitatebettercommunicationbetweenthoseinvolvedinrisk-baseddrugdevelopmentanddrugapplicationreview.KEYWORDS:controlstrategy;criticalqualityattributes;pharmaceuticalqualitybydesign;processund

6、erstanding;productunderstanding.INTRODUCTIONConsiderdocument;andICHQ11(DevelopmentandManu-factureofDrugSubstance)havebeenissued,ashavetheQualitybydesign(QbD)isaconceptfirstdevelopedbytheconclusionsofFDA-EMA’sparallelassessmentofQuality-By-qualitypioneerDr.JosephM.Juran(1).Dr.Juranbelieve

7、dthatDesignelementsofmarketingapplications(6–9).Thesedocu-qualityshouldbedesignedintoaproduct,andthatmostqualitymentsprovidehighleveldirectionswithrespecttothescopeandcrisesandproblemsrelatetothewayinwhichaproductwasdefinitionofQbDasitappliestothepharmaceuticalindustry.designedi