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1、PrinciplesandPracticesofAnalyticalMethodValidation:ValidationofAnalyticalMethodsisTime‐consumingbutEssentialChungChowChanEditor’sNote:ThisarticleisexcerptedfromachapterthatappearedinPharmaceuticalManufacturingHandbook:RegulationsandQuality,whichwasedi
2、tedbyShayneCoxGad,PhD.Thebookwaspublishedin2008byJohnWiley&SonsInc.Validationofananalyticalprocedureisthestatesthat“theaccuracy,sensitivity,speci?city,processbywhichitisestablished,bylaboratoryandreproducibilityoftestmethodsemployedstudies,thattheperf
3、ormancecharacteristicsofbythe?rmshallbeestablishedanddocumen-theproceduremeettherequirementsforitsted.”O(jiān)fcourse,asscientists,wewouldwanttointendeduse.Allanalyticalmethodsintendedapplygoodsciencetodemonstratethatthetobeusedforanalyzinganyclinicalsample
4、sanalyticalmethodusedhaddemonstratedaccu-willneedtobevalidated.Validationofanalyt-racy,sensitivity,speci?city,andreproducibility.icalmethodsisanessentialbuttime‐consumingFinally,managementofthequalitycontrolunitactivityformostanalyticaldevelopmentlabo
5、-wouldde?nitelywanttoensurethattheanalyt-ratories.Itisthereforeimportanttounderstandicalmethodsthatthedepartmentusestoreleasetherequirementsofmethodvalidationinmoreitsproductsareproperlyvalidatedforitsdetailandtheoptionsthatareavailabletointendeduseso
6、theproductwillbesafeforallowforoptimalutilizationofanalyticalhumanuse.resourcesinadevelopmentlaboratory.Therearemanyreasonsfortheneedtovalidateanalyticalprocedures.AmongthemCurrentGoodManufacturingPracticesareregulatoryrequirements,goodscience,andqual
7、itycontrolrequirements.TheCodeofTheoverarchingphilosophyincurrentgoodFederalRegulations(CFR)211.165eexplicitlymanufacturingpracticesofthe21stcenturyandinrobustmodernqualitysystemsisthatqualityDr.ChungChowChanisemployedatCCCConsulting.shouldbebuiltinto
8、theproduct,andtestingReachhimatchungchow@rogers.comalonecannotbereliedontoensureproductThisarticlewaspreviouslypublishedinDecember/Januaryquality.Fromtheanalyticalperspective,this2010inPharmaceuticalFormulation&Quality.willmeanthatanalyticalme
