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1、GUIDETOINSPECTIONSOFORALSOLIDDOSAGEFORMSPRE/POSTAPPROVALISSUESFORDEVELOPMENTANDVALIDATIONJanuary,1994Note:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(s).IINTRODUCTIONThisinspe
2、ctionguideprovidesinformationregardingtheinspectionandevaluationofthemanufacturingandcontrolprocessesusedtomanufacturesolidoraldosageformpharmaceuticalproducts.ThisdocumentprovidesguidancefortheFDAinvestigatorandpromotesuniformityandconsistencyduringtheinspectionandevaluationofthevalidationofthesol
3、idoraldosageformmanufacturingandcontrolprocesses.Itcoversthreephasesofthevalidationprocess;productdevelopment,designofthevalidationprotocol,anddemonstrationruns(validation)oftheequipmentandprocessinthemanufactureoffullscalecommercialproductionbatches.Althoughthisdocumentitisnotallinclusive,itaddres
4、sesmanyoftheissuesandexamplesofvalidationproblemsoforalsoliddosageformswhichinvestigatorsandanalystsmayencounter.TheinspectionteamisexpectedtoreviewotheragencydocumentsinpreparationfortheseinspectionsTheValidationGuidelineissuedbytheagencyin1987definesprocessvalidationasestablishingdocumentedeviden
5、cewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes.Thethreecomponentsofthisdefinitionincludedocumentedevidence,consistency,andpredeterminedspecifications.Documentedevidenceincludestheexperiments,dataandan
6、alyticalresultsthatsupportthemasterformula,thein-processandfinishedproductspecifications,andthefiledmanufacturingprocess.Withregardtoconsistency,severalbatcheswouldhavetobemanufactured,usingthefullscalebatchsize,todemonstratethataprocessmeetstheconsistencytest.Atleastthreebatchesareneededtodemonstr
7、ateconsistency.Thedevelopmentofaproductanditsmanufacturingprocessandspecifications,thedesignofthevalidationprotocol,andthedemonstration(validation)runsofthefullscalemanufacturingprocessrequiresscientificjud
