对一个API的EDQM检查失败案例分析及解决方案

原料药工厂审计AuditsAPIFacilitiesJPTConsultingKeithPowell-EvansCPAPE2011年年会Presentation内容•AuditActions•AuditTools•AuditGlossary•AuditProcedure•AuditDirective•AuditFindings(Regulatory)•AuditFindings(InternalAudits)•Examinations&Conclusions•审计活动•审计工具•审计术语•审计程序•审计指令•审计结果(药监)•审计结果(内部)•考察与结论pAXXXXXInternalProjectAuditProcess内部项目审计过程GapAnalysisReportByDepartmentRemedialScopeandPlanXXXXXXXProjectInternalAuditProcedureNoxxxxxxxInternalAuditreportNoxxxxxProjectInternalAuditGuidelineNoxxxxxxPrioritisationLinkswithOtherProceduresGuidelinesandProformasTrainingPlanRemedialActivitiesTrainingUp-datedTrainingRecordPassedtoClientGeneralProjectAuditScheduleExcelSheetT.B.DGapAnalysis(DummyAudit)ManualFieldsheetusingExcelSheetAuditPlanForWorkGroupExcelSheetNoxxxxxKeyQualitySystemsProceduresNoxxxxxxxRecordRetentionPolicyNoxxxxxInternalAuditActionFormNoxxxxxProgrammeQualityPlanSFDAProjectNoxxxxxxGeneralInternalAuditProcedureNo:xxxxGMPRegulationsGapAnalysisandAuditProcess差距分析以及审计程序MeetingtoRationaliseCorrectiveActionsSignoffActionformxxxxxAttachminutesofmeetingtoxxxxxMeetingtorationaliseGapresultspAXXXXXInternalProjectAuditProcess内部项目审计过程差距分析报告ByDepartment补救范围与补救计划XXXXXXX项目内部审计程序Noxxxxxxx内部审计报告Noxxxxx项目内部审计指南Noxxxxxx优先权考虑其他指南和形式培训计划补救措施培训更新培训记录递交客户通用项目审计计划表格T.B.DGapAnalysis(DummyAudit)ManualFieldsheetusingExcelSheet工作小组审计计划表格Noxxxxx关键质量体系程序Noxxxxxxx记录保留政策Noxxxxx内部审计措施表NoxxxxxSFDA项目质量计划Noxxxxxx通用内部审计程序No:xxxxGMP法规差距分析以及审计程序纠正措施讨论会签字xxxxx附上开会具体时间xxxxx差距结果讨论会AuditsActions审计活动•Preperation准备–Planning(Scope&Programme)策划(范围与日程)–Requests(Inc.Documents)要求(包括文件)–AuditScope审计范围•WalkRound巡查–FacilityInspection设施检查•Documentation文件•AuditReport审计报告–Development开发AuditsActions审计活动•AuditConclusions审计结论–Observatuons结果–Nonconformancerating不符合率AuditsTools审计工具•Glossary•AuditScope•AuditProgramme•Procedure•Schedule•Regulations•术语•审计范围•审计日程•程序•时间表•规章AuditsGlossary审计术语•Audit审计•Systematic,independentanddocumentedprocessforobtainingauditevidenceandevaluatingitobjectivelytodeterminetheextenttowhichauditcriteriaarefulfilled.•用系统的、独立的和有文档记录过程来获得审计证据和客观地评价，以确定哪些审计标准符合的程度。•NOTEInternalaudits,sometimescalledfirst-partyaudits,areconductedby,oronbehalfof,theorganizationitselfforinternalpurposesandcanformthebasisforanorganization’sself-declarationofconformity.•内部审计:有时被称为第一方审计、进行或代表组织本身供内部使用，可以构成一个组织声称符合性的基础。AuditsGlossary审计术语•Externalauditsincludewhataregenerallytermed“second-”or“third-partyaudits”.Second-partyauditsareconductedbypartieshavinganinterestintheorganization,suchascustomers,orbyotherpersonsontheirbehalf.Third-partyauditsareconductedbyexternalindependentorganizations.•外部审计:包括通常被称为“第二方”或“第三方审计”。第二方审计有组织的相关方进行,如客户或其他代表客户的人员。第三方审计由外部独立组织进行。•Auditcriteria审计标准•setofpolicies,proceduresorrequirementsusedasareference•用于参考的一系列的方针,程序或要求•Auditevidence审计证据AuditsGlossary审计术语•Recordsstatementsoffactorotherinformationwhicharerelevanttotheauditcriteriaandverifiable.NOTEAuditevidencecanbequalitativeorquantitative.•陈述相关审计标准与可获得事实的记录或其它信息。注意,审计证据可以是定性或定量。•Auditfindings审计结果•Resultsoftheevaluationofthecollectedauditevidenceagainstauditcriteria.NOTEAuditfindingscanindicateeitherconformityornonconformitywithauditcriteria,oropportunitiesforimprovement.•根据审计标准对所收集的审计证据进行评价结果。注意,审计结果可以表明，符合或不符合审计标准或改进的机会。AuditsGlossary审计术语•Auditprogramme审计程序•setofoneormoreauditsplannedforaspecifictimeframeanddirectedtowardsaspecificpurpose•为一个特定的时间限度与针对特定目的的一个或多个审计计划•Auditee被审计方•organizationbeingaudited被审计的组织•Auditor审核员•personwiththecompetencetoconductanaudit•有能力实施审计的人员AuditProcedure审计程序INTERNALAUDITREPORTTEMPLATEAuditNo.:Ref:“InternalAuditProcedure(Template)”‘forinstructionsoncompletionofthisformsee(JPT/SOPAUD/001/00).’AuditCoverSheetSummaryofAudit:PurposeandScopeofaudit:Date(s)ofauditNamesofauditors:Namesofauditees:Attendeesatopeningmeeting:Attendeesatclosingmeeting:EffectivenessofCAsfromlastaudit:NoofCriticalNCRsraised:Datereportissued:NoofMajorNCRsraised:Dateresponsedue:NoofMinorNCRsraised:NoofRECsraised:NCR'sRootCauseClassification-Tobecompletedbytheauditeeoncompletionofinvestigation:Referto“Non-ConformanceandRootCauseClassification”procedure,fordetailsofclassifications.ClassPeopleMethodMachineMaterialMeasurementEnvironmentQuantityAuditReportApprovals:Reportpreparedby/Date:LeadAuditorTargetDateforAuditClosure:CloseoutofAuditCompletionofallCAsverifiedby/Date:LeadAuditorINTERNALAUDITREPORTAuditNo.:AReferto“InternalAuditProcedure”forinstructionsoncompletionofthisform.ReportNo:ContactPerson:ReportTypeNonComplianceRecommendationClassification:CriticalMajor:Minor:Section1:DetailsofNonComplianceorRecommendation:(Tobecompletedbyauditor)NCRClassification–PleasetickwhichappliesCAPADecision(NoteallcriticalNCRareautomaticCAPA,MajorNCRareelevatedtoCAPAwhentheCAPAcriteria‘CLIENT’ismet)CriticalNCRPleasereferenceCAR#:MajorNCRPleasereferenceCAR#:(ifapplies)MinorNCRN/ARecomendationN/AEachnon-conformanceorrecommendationmustbeindividuallynumbered.Preparedby/Date:Section2:Response:(Tobecompletedbyauditee)2a:Investigation:(i.e.whatistherootcausetothenon-compliance?N/Athissectionforarecommendation.)AssignNCRRootCauseClass