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ID:46126352
大小:393.57 KB
页数:22页
时间:2019-11-21
《不受限制的基本GMP审核检查表》由会员上传分享,免费在线阅读,更多相关内容在工程资料-天天文库。
1、不受限制的基本GMP审核检查表RetailFactoryAuditReportNon-RegulatedBasicGMPBASICGMPREQUIREMENT/CRITERIA/REFERENCETotalPossibleScorePointsScoredYes/NoN/AMajor/MinorCOMMENTSFacilitiesandEquipmentFE1Isthefacilityclean(internal/external)?Throughoutthecourseoftheassessm
2、ent,observationofcleanlinessshouldbetaken.Cleanlinessshouldbedefinedasanenvironmentthatreducesand/oreliminatesthepotentialforcontamination.2FE2Aretherewrittenproceduresaddressingthemaintenanceofthefacility?PreventiveMaintenaneepoliciesandschedulessho
3、uldbedocumented・Recordsshouldbeavailableforreviewandshouldcontaininformationregardingdailypre-operationequipmentinspection,dailymonitoringofequipmentfunction,dailyhousekeepingactivities,sanitationactivitiesandanyothernecessaryactivitiestomaintainthes
4、afetyandqualityofproduct.2FE3Istherealistofapprovedchemicalsformaintainingthesanitationofthefacility?Chemicalsusedforanyoftheaboveactivitiesshouldbedefinedwithintheapprovedproceduresandpolicies.MaterialSafetyDataSheetsshouldbemaintainedforallchemical
5、s.AnappropriatesampleofchemicalsshouldbeselectedandMSDSrequestedforeach.IfanychemicalsareobservedinusewithoutapprovalorifanyofthechemicalsselecteddonothaveMSDSprovided,theanswerisNO.1Isstorageofchemicalsusedinthefacilityadequate?Ensurethatallchemical
6、sarestoredinamarinerconsistentwiththeinstructionspertheirMSDSsheets.Additionally,ensurethatthemethodofstorageisinsuchamannertoeliminateproductcontamination.AnswerisNOifstorageconflictswitheitherrequirementabove.3Isthefacilityinsatisfactorystructuralc
7、ondition?NoRodentEntryPoints,NobrokenGlassorWindows,Ceilingdoesnotindicatewaterdamageorstructuraldefects.3Iswastematerialhandiedappropriately?Ensurethedumpsterareasarecleanandwellorganized・Externalwasteisnotexcessive.1Isthedesignofthefacilityadequate
8、toallowforsmoothflowofmaterialsandreducepotentialforcontamination?2Arethereadequateenvironmentalcontrolsforthebuilding?Iftheproductunderassessmentrequiresenvironmentalcontrols,ensurethatthesupplierhascontrolledandverifiedtemperatureatcriticalareas.If
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