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1、LectureFourProcessValidationandQualityAssuranceOutlineIntroductionProcessControlandValidationProspectiveValidationConcurrentValidationRetrospectiveValidationSamplingandTestingAcceptanceLimitsandProcessValidationRawMaterialsInspectionIn-processControlsReleaseTargetsDiscussionInt
2、roduction12…i…N-1NRawMaterialFinishProductManufacturingStepsiUnitProcessStep(i)withAssociatedProcessCharacteristicsTotalManufacturingProcess=FIGURE6.1.1Processdecomposition.Amanufacturingprocessisacontinuousprocessthatusuallyinvolvesanumberofstages(seeFig.6.1.1).Asanexample,con
3、siderthemanufacturingprocessfortabletsofapharmaceuticalcompound.Table6.1.1summarizesthecriticalstagesofthemanufacturingprocess.ItcanbeseenfromTable6.1.1thattheprocessconsistsofseveralcriticalstagesincludingtheactivepreblendingstage,theprimaryblendingstage,thelubricantpreblsndin
4、gstage,thefinalblendingstage,andthecompressionstage.Theconceptofin-processcontrolandprocessvalidationisnotnew,whichhasbeenwellestablishedinvariousindustriesintheUnitedStates.Thepharmaceuticalindustry,however,isdifferentfromotherindustriesforatleastfollowingtwoaspects.First,drug
5、productsareusuallyadministeredtohumansubjectsandabsorbedintotheirbodysystem(almost)torelieveacertainillness.Itisthereforeimportanttoensuretheidentity,strength,quality,andpurityofdrugproducts.AnyderivationfromUSP/NFspecificationsfortheidentity,strength,quality,andpurityofdrugpro
6、ductscanresultnotonlyinnotachievingitseffectivenessbutalsocausesevereadersereactions.Second,inthepharmaceuticalindustry,sizeofabatch(e.g.,tablets)isusuallymeasuredintheunitofmillionsoftablets.Thebatchofmillionsoftabletsiseitheracceptedorrejected,dependingontheresultofafewtablet
7、ssampledfortheUSP/NFtestsforpotency,contentuniformity,dissolution,anddistintegration.Therejectionofbatchisusuallyverycostlybecausethebatchmayberecoveredforreuse.Inthiscausethetraditionalacceptancesamplingplanadoptedbyotherindustriesmaynotbefeasiblefordrugproducts.Itisthensugges
8、tedthatawell-establishedcontrolprocedurebeusedtomonito
