How QbD and the FDA Process Validation Guidance Affect Product Development and Operations， Part 1 Peter H. Calcott.pdf

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1、FOCUSON...COMPLIANCEHowQbDandtheFDAProcessValidationGuidanceAffectProductDevelopmentandOperations,Part1byPeterH.Calcottarlierthisyear,theFDAissuedWhenitwasfirstincorporatedinitslong-awaitedprocessthemid1980s,PVwasviewedasanewEvalidationguidancedocument,regulatoryrequirementtobeperformedwhichhadbee

2、nseveralyearsinsometimeinphase3oftheclinicaldevelopment.Itiswellwrittenanddevelopmentcycle.Thatwaswheneffectivelyarticulateswhatmanyprocesseswerebeinglockeddownandprogressivecompanieshavebeencompanieshopedtheirproductswouldthinkinganddoingforyears.Butbeprovensafeandefficacious.Whethermanypeopleint

3、heindustryaregoingforadrugapprovalorbiologicsIoanaDavIes(www.Istockphoto.com)askingquestions:Howwillitaffectlicensure,acompanyeithersubmittedourprocessdevelopmentprograms?protocolsandperformedPVlater(butdrugdevelopmentlifecycle,thatitHowwillitaffectthesubmissionsandbeforesaleofthefirstlots)orsubmi

4、ttedneverstops,andthatitisavalue-licensureofourproducts?AndhowthecompletedPVreportswithitsaddedactivity.Thiscanbedescribedwillitaidinourcommercialsubmission.Oncethatwascomplete,usingwhatIcallthe“fourDs”:operations?Orwillithavenoeffect?youcouldputyourreportsonashelf•Design(buildeachprocesstoasetCon

5、siderwhatthedocumentsays.andforgetaboutthemunlessyoumadeofstandardsorrequirementsfocusingInthesimplestterms,itarticulatesradicalchangestoyourproductoronwhatacustomerwants/needs)fourmainmessages.Astrongprocessprocess.Thiswasnotavalue-added•Demonstrate(byconductingdevelopmentprogramisessential—activ

6、ity,butratheracheck-the-boxexperimentsandvalidationtoshowpreferablyusingqualitybydesignprocess.thatprocessandproductmeetdesign(QbD)—toeventuallyobtainMeanwhile,theFDAwantedallrequirements)expeditedproductapprovalandbenefitlegacyproducts(thosethathadbeen•Document(thecornerstoneoffromarelaxedregulat

7、orypositionwithapprovedbeforePV)tohavetheirgoodworkisrecordingitforposterity)theagency.Processvalidation(PV)isprocessesvalidated,too.Thiscreateda•Determine(ensurethatresultslinkedintothatactivityinverifyingitsflu