2014版-gmp验厂审核检查表

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1、RetailFactoryAuditReportNon-RegulatedBasicGMPQTReport:AuditDates:审核日期ReportDate:报告日期AuditOwner:AuditActiFactoryName:工厂名字LeadAuditor:审核组长Address:地址Auditor(s):审核员FailPassWithConditionsPass#MajorCAPAs:Allprogramrequirementsfor certificatemet? (RCPCertCommitteeonly)#MinorC

2、APAs:Noncompliant不符合Marginal警戒Compliant符合CAPAfollow-uprequired?NOYESNOTRCPFactoryGrade:工厂等级FactoryScore:得分0.00%YES ☐NO☐Scopeofaudit:Products:Mostrecentauditdate:Whatentityperformedtheaudit?Auditresult:Typesofcertificationsmaintained:FDARegistrationTypeandNumber:Company

3、Representativeduringaudit:ProductionArea-Ft 2 :#productionlines:PackagingArea-Ft 2 :#Packaginglines:Warehouse-Ft 2 :TotalPlantSize-Ft 2 :COMPLETESECTIONBELOWFORCAPAFOLLOW-UPONLYQTReport:AuditDates:ReportDate:FailPassWithConditionsPass#MajorCAPAs:#MinorCAPAsRe-Auditrequ

4、ired?Allprogramrequirementsforcertificatemet?(RCPCertCommitteeonly)NOYES NOTRCPNoncompliantMarginalCompliantFactoryGrade:FactoryScore:0.00%YES ☐NO☐#BASICGMPREQUIREMENT/CRITERIA/REFERENCEGMP要求/标准/参考TotalPossibleScore最高可能得分PointsScored实际得分Yes/No是/否Majororminor主要/轻微Facili

5、tiesandEquipment厂房/设备FE1Isthefacilityclean(internal/external)?Throughoutthecourseoftheassessment,observationofcleanlinessshouldbetaken.Cleanlinessshouldbedefinedasanenvironmentthatreducesand/oreliminatesthepotentialforcontamination.工厂是否干净（评估的整个过程都要观察工厂清洁情况，工厂应该有定义清洁的环境

6、要素并持续改善清洁状况）200FE2Aretherewrittenproceduresaddressingthemaintenanceofthe facility? PreventiveMaintenancepoliciesandschedulesshouldbedocumented.Recordsshouldbeavailableforreviewandshouldcontaininformationregardingdailypre-operationequipmentinspection,dailymonitoringofeq

7、uipmentfunction,dailyhousekeepingactivities,sanitationactivitiesandanyothernecessaryactivitiestomaintainthesafetyandqualityofproduct.有没有书面的厂房/设施维护程序？预防性维护的政策和程序。每日开机检查记录，每日设备功能检查记录，每日打扫卫生记录，以及其他所需的工作来保证产品的安全和质量……200FE3Istherealistofapprovedchemicalsformaintainingthesan

8、itationofthefacility?Chemicalsusedforanyoftheaboveactivitiesshouldbedefinedwithintheapprovedproceduresandpolicies.Mat