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1、AuditChecklistforDrugIndustryDisclaimerThefollowingchecklistisintendedtoaidinthesystematicGMPauditofafacilitythatmanufacturesdrugcomponentsorfinishedproducts.Theadequacyofanyproceduresissubjecttotheinterpretationoftheauditor.Therefore,theauthoracceptsnoliabilityforanysubsequen
2、tregulatoryobservationsoractionsstemmingfromtheuseofthisauditchecklist.InstructionsforUsingthisAuditChecklist:Beforestartinganon-siteaudit,plantheaudit.Reviewpastaudits,noteindicationsofpossibleproblemareasanditems,ifany,thatwereidentifiedforcorrectiveactioninapreviousaudit.If
3、youarenotalreadyfamiliarwiththisfacility,learnthetypeofproductproducedhereandhowitisorganizedbypersonnelandfunction.Whatdoesyour"customer",i.e.,yoursuperiororseniorfacilitymanagement,expecttolearnfromthisaudit?·Thechecklististobeusedwithanotebookintowhichdetailedentriescanbema
4、deduringtheaudit.·Whilethechecklististoguidetheauditor,isnotintendedtobeasubstituteforknowledgeoftheGMPregulations.·Althoughasinglequestionmaybeincludedaboutanyrequirement,theanswerwillusuallybeamulti-partonesincetheauditorshoulddeterminetheaudittrailforseveralproductsthatmayu
5、semanydifferentcomponents.Enterdetailsinyournotebookandcrossreferenceyourcommentswiththequestions.·Atleastthreeproductionbatchesshouldbeselectedforthoroughanalysistoinclude:(a)traceabilityofallcomponentsormaterialsusedinthesubjectbatches,(b)documentationofrawmaterialorcomponen
6、t,in-process,andfinishedgoodstestingforthesubjectproductbatches,(c)warehousinganddistributionrecordsastheywouldrelatetoapossiblerecall.·Responsesenteredonthechecklistshouldbeconsistent."X"isrecommendedfor"NO";acheckmarkfor"YES";"n/a"fornotapplicabletoquestionsthatdonotapply.An
7、asteriskandnotebookpagenumbershouldbeenteredonthechecklisttoidentifywhererelevantcommentsorquestionsarerecordedinyournotebook.·Thenotebookusedshouldbealaboratory-typenotebookwithboundpages.thenotebookshouldbeclearlylabeledastotheaudittype,date,andauditor(s).Manyauditorsprefert
8、ouseanotebookforasingleauditsoitmaybefiledwiththechecklistand
