PharmaceuticalSupplyChainInitiative(PSCI)CorrectiveActionPlanReportforPSCIAuditatSuppliertoPharmaceuticalIndustryAUDITORANDAUDITREPORTINFORMATIONReportNumber:Dateofaudit:Dateandtypeofpreviousaudit:AuditFirmName:LeadAuditorName:Title:NamesoffurtherauditorsPhoneNumber:EmailAddress:FACILITYDETAILSCompanyName:ParentCompanyName(ifapplicable)StreetAddress:City:State/Province/County:Postal/ZipCode:Country:FacilityBackgroundInformationPleaseindicatewhichofthefollowingbestdescribesthisfacility(checkallthatapply):∙API(Drugsubstanceandintermediates)∙Drugproduct****checkboxes∙PrimaryPackaging∙SecondaryPackaging,∙Distribution,∙Biologicalmanufacture,∙Chemical∙R&D∙Serviceprovider∙Other(describe)Describetypeofworkcurrentlybeing,orproposedtobe,performedatthisfacility,andproducttype(s):SITECONTACTINFORMATIONSiteRepresentativeName(host):Title:PhoneNumber:EmailAddress:PSCISupplierCorrectiveActionPlanFindings,CorrectiveActionsandFollow-upFindingNumberThereferencenumberoftheFindingfromtheAuditReport,forexample,DiscriminationNo.7FindingTypeC=CriticalO=OtherPleasestatewhetherCritical,OtherFindingDescriptionofFindingPleasedescribethefinding(asdoneinthePSCIAuditReport)AgreedCorrectiveActionsDetailsofactionstobetakentofollowupontheFindingRecommendedCompletionTimescaleTimescale(Immediate,30,60,90,180,365days)VerificationMethodDesktop/Follow-UpVisitAgreedbyManagementandNameofResponsiblePerson:NoteifmanagementagreetotheFinding,anddocumentnameofresponsiblepersonVerificationEvidenceandCommentsDetailsoncorrectiveactionevidenceStatusOpen/ClosedorcommentNote:CriticalObservations:Arehighorveryhighriskobservationsthatrequireimmediateactiontoprotecthumanlife,thehealthofemployeesortheenvironment;mayresultinlossoflicensetooperate,damagetoreputation. Acriticalobservationrequiresimmediatecorrectiveactionbythesupplier.OtherObservations:Areobservationsthatrequirecorrectiveactionsthataremanagedagainstatimelinecommitmentbytheauditedsite.PSCISupplierCorrectiveActionPlanConfirmationPleasesignthisdocumentconfirmingthattheabovefindingshavebeendiscussedwithandunderstoodbyyou:(sitemanagement)SiteRepresentativeSignature:NameTitleDateAuditorSignature:NameTitleDatePleaseindicatebelowifyou,thesitemanagement,disputeanyofthefindingsIdisputethefollowingnumberedFindings:PleaseindicateifthisAuditReportandCorrectiveActionPlancanbesharedwithPSCImembercompanies.AgreetosharethecompletedAuditReportandCorrectiveActionReportwithallPSCImembers:Yes_______No_______AgreetosharecompletedAuditReportandcorrectiveActionReportwithonlyspecificPSCImembers:_______________________________________________Signed:TitleDateSiteComments:
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