COSTCO好多GMP质量验厂要求及标准COSTCOGMPQualityauditStandardrequirement

COSTCO好市多GMP质量验厂要求及标准COSTCOGMPQualityauditStandardrequirement#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FacilitiesandEquipment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要素并持续改善清洁状况)200Aretherewrittenproceduresaddressingthemaintenanceofthefacility?PreventiveMaintenancepoliciesandschedulesshouldbedocumented.Recordsshouldbeavailableforreviewandshouldcontaininformationregardingdailypre-operationequipmentinspection,dailymonitoringofequipmentfunction,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 200FE3Istherealistofapprovedchemicalsformaintainingthesanitationofthefacility?Chemicalsusedforanyoftheaboveactivitiesshouldbedefinedwithintheapprovedproceduresandpolicies.MaterialSafetyDataSheetsshouldbemaintainedforallchemicals.AnappropriatesampleofchemicalsshouldbeselectedandMSDSrequestedforeach.IfanychemicalsareobservedinusewithoutapprovalorifanyofthechemicalsselecteddonothaveMSDSprovided,theanswerisNO.是否有清洁用化学品清单。这些用来清洁的化学品应该有合适的批准程序批准，有SDS数据。如果发现任何没有在清单中的化土品，或则没有MSDS，答案就应该是No”1学00FE4Isstorageofchemicalsusedinthefacilityadequate?EnsurethatallchemicalsarestoredinamannerconsistentwiththeinstructionspertheirMSDSsheets.Additionally,ensurethatthemethodofstorageisinsuchamannertoeliminateproductcontamination.AnswerisNOifstorageconflictswitheitherrequirementabove.存储化学品的设施是否合适充足？确保所有化学品都按照其MSDS要求合适存储，避免污染。否则答案为‘NO”300FE5Isthefacilityinsatisfactorystructuralcondition?NoRodentEntryPoints,NobrokenGlassorWindows,Ceilingdoesnotindicatewaterdamageorstructuraldefects.厂房结构是否令人满意，没有虫害入侵点，没有破碎的玻璃或窗户。天花板没有漏水的痕迹。300BASICGMPQuality-2018V3

FE6Iswastematerialhandledappropriately?Ensurethedumpsterareasarecleanandwellorganized.Externalwasteisnotexcessive.肥料处理是否合适，垃圾桶附近干净整洁。100FE7Isthedesignofthefacilityadequatetoallowforsmoothflowofmaterialsandreducepotentialforcontamination?工厂平面结构设计是否合理，可以是物料流转顺畅，避免潜在的污染风险200FE8Arethereadequateenvironmentalcontrolsforthebuilding?Iftheproductunderassessmentrequiresenvironmentalcontrols,ensurethatthesupplierhascontrolledandverifiedtemperatureatcriticalareas.Ifenvironmentalcontrolisinadequate,theanswerisNO.Ifenvironmentalcontrolisnotapplicabletotheproduction,theanswerisN/A.建筑物是否有合适的环境控制，如果产品有环境控制需求，请确保供应商有控制和确认温度。300FE9Isthelightingadequateforthebuilding?建筑内部照明是否充足100FE10Isthepestcontrolprogramadequate?Ensurethatacontractexiststhatdocumentsaregularlyscheduledpestcontrolserviceprogram.Thecontractpackageshouldincludeataminimum:a)writtendocumentationregardingtheserviceperformedandtypeofmaterialsused;b)acurrentmapindicatingthelocationsofallrodenttraps;c)copiesofthelicensesandcertificatesofinsuranceforthepestcontrolcompanyandcurrentlicenseforinspectors.Reviewarepresentativesampleofinspectionrecordsfromthelast12months.Ensurethatanypestproblemsnotedhavebeenaddressedandhadbeenaddressedpriortothenextinspection.Ensurethetraps/devicesaretraceableeitherbynumericallabeling,barcodingorothermethod.Ensurethatthepestcontrolinspectorhasinitialedorprovidedsomeotherdocumentationtosupportthatalltrapshadbeenproperlyinspected.Finally,toreceiveaYESforthisquestion,nosignofrodentactivitywasnotedduringthecourseofthisassessment.虫害控制程序是否合适？确保有外发的定期虫害控制合约合约至少包括a)服务内容和所有材料b)鼠笼的安放位置图c)虫害防治公司的营业执照，检查12个月的虫害控制记录，鼠笼等设备有编号，可以追溯。鼠笼等设备合适安装并定期检查证据300FE11Arethewashroomsandtoiletscleanandingoodworkingorder?Clean,stockedwithAntibacterialSoapandsingleusenapkin/towel,runninghotwater.水房和厕所是否良好？干净，有防菌肥皂和一次性纸巾，热水300FE12Isanorganizedsparepartsinventorykeptonhandatthefactory?Lookforaroomorareaseparatefromproductionthatcontainssparepartsfortheproductionequipment.Doesnotneedtobeallspareparts,butataminimumshouldbecriticalpartsneededtokeeptheequipmentrunning.Factoryshouldhaveinventorylist.备件仓是否组织良好？备件仓需同生产隔离。关键零件必须要备件并有清单控制100BASICGMPQuality-2018V3

TOTALSCOREFORTHISSECTION2500QualitySystem品质系统OrganizationandPersonnel组织和人员QS1IsaTableofOrganization(ToO)availableforreview?Current?Approved?Controlled?MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.组织架构图？最新，有批准和受控200QS2Isqualityassuranceindependentofmanufacturing?EnsurethattheToOdescribesseparationofmanufacturingauthorityandqualityassuranceauthority.有没有独立于生产的品质保证部门。组织架构同应该有体现200QS3Areuptodatebiographies(CVs)availableforsupervisorypersonnelshownontheToO?主管以上人员必须要简历保存100QS4Doesthequalitydepartmenthaveadequatecoverageduringallshifts?Reviewlast30daysofshiftschedules.Foreveryproductionshift,theremustbedocumentedQCcoveragetoscoreaYES.*Guidance:"DocumentedQCCoverage"maybedemonstratedthroughacombinationofbothofthefollowingpractices:1)Designationof"QualityResponsible"operator(s)duringa2ndor3rdshift.Thisisacceptablesolongasverificationoftrainingmaybeprovidedandconclusiondrawnthatdesignated'QualityResponsible"operatorshavetheeducation,experienceandknowledgetoactintheroleofQC.2)ThevendormusthaveprocedureandrecordstoensurethatQAreviewsandreleasesallbatchespriortoshipment.品质部门是否有足够的人员去覆盖所有的生产班次?检查最近30天的生产安排，每个生产班，都必须有品质文件，“品质文件”是指/：)每班有指定合格的品质负责人，且品月负责人有合适的培训，经验和知识2)供应商必须有程序和记录确保出货tqa检查每批货物。3后00QS5IsthereawrittenprocedureforgeneralGMPtraining?Thisshouldbeaprocedureorotherdocumentsdefiningfrequencyoftraining,generalscopeoftraining,trainingproviderandmethodologyfordeterminingcompetency.GMP培训程序？程序要定义培训频率，培训范围，讲师和培训方法100QS6Aretrainingrecordsavailableforindividualsrandomlyselected?Randomlyselectanappropriatesamplebasedonthesizeofoperationtoverifytrainingrecordsexist.Ifnorecordexistsforsampledemployees,scoreNO.随机检查培训记录100BASICGMPQuality-2018V3

QS7Dotrainingrecordscontainnames(trainer/trainee),datesandsubjectmatter?AlsoensuretherecordsdemonstrateconformancewiththeproceduretoscoreYES.培训记录是否报考名字(讲师和学员)，日期和培训主题。200QS8Isthereasufficientmeansforverifyingtraineecomprehension?Reviewthemethodoftrainingverification.Ensurethatitisappropriatetotheextentofresponsibilityfortheproduct.是否有合适培训效果确认方法200QS9Aresatisfactorytrainingmaterialsavailableforreview?Slides,handouts,otherdocumentationtodemonstratetrainingprovidedconformstoprocedure.是否有合适的培训材料，幻灯片，印刷材料100QS10DoGMPtrainingmaterialsadequatelyaddressfacilitysanitation,personalhygiene,andrecordkeeping?培训材料是否有涵盖厂房清洁卫生，个人卫生和记录保存200QS11Doemployeespracticesanitationandhygieneinthemanufacturingoperations?Duringthewalkthroughofproduction,storage,etc.observeemployeestoensureallsanitationandhygienepoliciesareimplemented.Ifobservationdeterminespoliciesarenotbeingfollowed,mustscoreNO.员工是否按照卫生要求开展工作，在现场走访时观察员工和实施的人身状况300QS12Areonthejob(OTJ)trainingrecordsavailableforindividualsrandomlyselected?Specificallyverifyanyemployeeobservednotfollowingsanitationandhygienepoliciestodetermineifthey'vebeenprovidedthetraining.随机检查员工在职培训记录，特别检查那个没有按照卫生要求做事的员工200QS13AreOTJtrainingrecordscompleteandadequate?Containsnames(trainer/trainee),datesandsubjectmatter,specificreferencetomachine,process,oractivity.岗位培训记录是否详实，包括姓名(讲师和学员)，日期，主题，参考材料和相关活动200QS14AreSOPsavailableforreview?SOPsshouldcoverallcriticalprocessesutilizedforthecontrolledmanufactureofproduct(s)includedintheassessmentscopetoscoreYES.有没有SOP(标准作业程序)，SOP应该涵盖所有关键受控工序300QS15AreSOPswritten,identifiedandapprovedinasatisfactorymanner?Current?Approved?Controlled?MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.SOP是否文件化，有编号和被批准。最新，有审批和受控300BASICGMPQuality-2018V3

QS16IsdistributionofnewandrevisedSOPsandretrievalofobsoleteSOPsadequate?有没有SOP修改，分发控制程序200QS17DodocumentedINSPECTIONproceduresorinstructionsexist?Reviewinspectionproceduredocumentation.检查作业指导书，100QS18AreSOPsreviewedperiodicallytoensuretheirapplicabilitytocurrentpractices?SOP定期审查100QS19Isthereadocumentedchangecontrolprocedureforplannedandunplannedchangestoproductionprocesses?有没有文件化的变更控制程序，包括计划内的生产工序变更和非计划的变更300QS20Arechangesrelatingtomanufacturing/packagingprocessesadequatelyapproved,wherenecessary?ThesechangesshouldbeapprovedbytheresponsiblepartiesidentifiedinthechangecontrolprocedureindicatedabovetoscoreYES.有关生产包装的变更是否有合适的批准程序。300QS21Arelogbooksavailableforreviewwithrespecttoproduction?生产登记本100QS22Istheuseoflogbooksdetailedinawrittenprocedure?文件化的生产登记本使用说明100QS23Arelogbooksclearwithrespecttoactionstakenbyindividuals?生产登记本记录清晰，可以看清楚没有人的动作记录。100QS24Dologbooksexhibitgooddocumentationpracticeswithrespecttochanges,legibilityandsequenceofevents?Nowhiteout,scratchoutmarks,etc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.生产登记本是否更改谨慎，清晰易读100QS25Arelogbooksperiodicallyreviewedtoensuretheiradequacy?生产登记本记录是否定期检查100QS26Isthereanadequatewrittenprogramforthemaintenanceofproductionrecordsforeachfinishedproductmanufactured?是否有合适的文件化程序来维护每批产品的生产记录300QS2Dobatchproductionrecordscontainadequateinformationwithrespecttothepackagingoffinishedproducts?Ensure300BASICGMPQuality-2018V3

7packaginglabels/informationincludeadequateinformationtosupportthatproductionrecordsareaccuratewithrespecttoidentification,quantity,weight,material,etc.批生产记录是否包括关于成品包装的合适信息，标签信息QS28Dobatchproductionrecordscontaintherequiredinformationnecessarywithrespecttoassuringthequalityoffinishedproducts?Ensureproductionrecordscontainidentificationofthetypeofmaterial,amountofmaterial,andverificationofanycriticalstepsperthespecificationtoscoreYES.批生产记录是否包含原材类型，数量个关键步骤确认规范300QS29Dobatchrecordsexhibitgooddocumentationpracticeswithrespecttochanges,legibilityandadequacyofentries?Nowhiteout,scratchoutmarksetc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.批生产记录改动谨慎，清晰易读。没有涂鸦，修改有备注时间和签名100QS30ArebatchrecordsreviewedbyQApriortoarchival?批记录在存档前必须有QA检查确认300QS31Areadequaterecordsmaintainedwithrespecttotheseinvestigations?不良品原因调查是否有记录200QS32Doinvestigationsincludeareviewofproductionandlaboratoryeventswhichmaycontributetoorbethecauseofthefailure?调查是否包括检查生产记录，实验室记录200QS33Ifinvestigationsareinconclusiveandretestingisconducted,istheapproachtoretestingbasedonsoundrationale?如不良调查得出结论需要从新测试，那么测试方法是有合适300QS34Doallinvestigationsconcludeanactualorprobablecauseforthefailure?是否所有调查都给出实际或可能的原因200QS35Areinvestigationscompletedwithinareasonabletimeframe?失效调查是否在合理的时间内完成300QS36DoesQualityAssuranceadequatelyreviewthefailureinvestigations?品质部门是否合适地审查这些调查300BASICGMPQuality-2018V3

AnnualProductReview/InternalAudits/CorrectiveandPreventativeActions年度产品审核/内审/预防改善100QS37IsthereanadequatewrittenprocedureforconductingProductReviews?Thisshouldcontainfrequency,methodology,responsiblepartiesandrecordkeepingrequirements.是否有合适的程序来主导产品审查，包括审核频率，方法，责任人和记录保持QS38Isthereanadequatewrittenprocedureforconductinginternalaudits?Thisshouldcontainfrequency,methodology,responsibleparties,recordkeepingrequirements,authority,followuporcorrectiveactionreferencebasedoninternalauditresults.是否有内审程序，包括频率，方法，责任方，记录，拥有者改善行动跟进200QS39Areinternalauditsbeingconductedaccordingtotheprocedure?内审是否按程序进行200QS40Issupportingdocumentation(schedules,auditreports,CAreports)fortheauditsavailable?Dothesedocumentsandrecordsdemonstrateconformancetotheprocedure?内审计划，内审报告，内审改善报告，200QS41Areresponsestotheauditfindings/observationsintheformofcorrectiveand/orpreventativeactions(CAPA)addressingrootcause?内审负责撰写改善行动的人是否有也谢清楚了不良发生的原因200QS42AreCAPAsbeingcompletedandinstitutedwithinareasonabletimeframe?改善行动是否在合理的时间内完成200QS43DoesQualityAssurancefollow-upanddetermineiftheappropriateCAPAhasbeencompleted?ThisshouldbedocumentedviatheCorrectiveActionformorrecordutilizedbythefactoryORviaasubsequentinternalauditofthedeficientarea.QA是否跟进并确保执行合适的改善行动300QS44ArecorrectiveactionplansdevelopedanddocumentedbasedontheresultsoftheweeklyQCmeetings?IstheredocumentationofcorrectiveactionplansintheQCmeetingnotes?MustseetoscoreaYES.是否在每周的品质会议中开发改善行动记录。200—TOTALSCOREFORTHISSECTIONMaterialSystem&SupplierQualityManagement原材料和供应商品质管理8900ComponentsHandling/HoldingandDistributionBASICGMPQuality-2018V3

部件/零件的处理与分发MS1Doesthefactoryhaveadocumentedprocesstomakesurethatincomingrawmaterials,components,and/orsub-assembliesconformtospecifications,qualitystandardsandUSSafetyrequirements?Verifythatthereisaprocessdocumentedtoensureallincomingrawmaterials,componentsand/orsub-assembliesconformtospecificationsandUSSafetyrequirements.Painttestedforleadcontent,etc.工厂是否有文件化的程序来确保原材料，零件，外发加工品符合产品规范，品质标准和美国安全要美国安全标准包括油漆测试铅含量等3，00MS2Isthereanadequateprocedureforthereceipt,samplingandidentificationofallrawmaterials?Ensurethatinspectionproceduresextendtoreceiptandqualificationofrawmaterial.Ensurethatrecordsexisttosupportconformancetoprocedure.Ifnoprocedureorrecordsexist,scoreNO.是否有文件化的检查程序来接受，抽样和标识所有原材料。确保检查程序包括接受和认证原材料。确保所有检查记录按照程序3进行00MS3Arethereadequatespecificationsforallcomponentsandrawmaterialsreceived?Identification,type,grade,size,amount,weight,supplier,etc.原材料/零件的产品规格，包括识别，类型，等级，大小，数量，重量，供应商等信息300MS4ArerawmaterialsadequatelyquarantineduntilreleasebyQAtoproduction?Samplemultiplerawmaterialsandensurearecordexiststotracefromreceipttoqualification.Ifnotrailexists,scoreNO.是否所有原材料在分发给生产部之前都初检查记录，抽样300MS5Areallcomponents(rawmaterials,primaryandsecondarypackaging)beingtestedagainstappropriateandestablishedspecifications?所有零件(原材料，主要和次要包装材料)都按照和事的规格测试300MS6Whererawmaterialsarenotfullytestedagainstspecifications,isthereaprogramforqualifyingsuppliers?如果原材料没有合适的测试，有没有供应商认可程序300MS7Wherehistoricaldataisusedtoqualifysuppliers,doeshistoricaldataincludeinformationonallthecharacteristicslistedinthespecification?如果历史数据用来认证供应商，这些历史数据是否包括材料规格书中列出的所有特征。200MS8Doesthehistoricaldatasupporttheuseofreducedtesting?是否有历史数据来支持减少测试的动作200BASICGMPQuality-2018V3

MS9Whereauditsareusedtoqualifysuppliers,areauditreportsadequateandavailableforreview?Auditreportsshouldcontainnameofsupplierandauditor.Theyshouldcontaininformationregardingtheprocessand/ordepartmentscovered.Theyshouldreferencethemethodologyand/orrequirementsusedtoassessthesupplier.如果用审查来认可供应商，那么是否有审查报告，这些报告包括供应商名字，审核员，他们也应该包括流程，部门。应该有审要求等2查方法，00MS10Doesaprogramforperiodicauditingofvendors(materialandservicesuppliers)exist?是否有对供应商定期审查200MS11IfCertificatesofAnalysisareaccepted,verifythatatleastononelotperyeartheitemisfullytested?如果接受分析认证。至少对原材料每年测试一批300MS12Arerawmaterials,in-processmaterialsandfinishedproductsadequatelystoredandhandledsoastoavoidexposuretophysical,chemicalandmicrobiologicalcontamination?原材料，在制品和成品存储是否良好，避免暴漏在物料理，化学和微生物污染的环境中300MS13IsthereanadequateprogramtoensureFIFO?是否有先进先出控制？100MS14Isthereaformalprogramforthere-qualificationofrawmaterialsstoredforlongperiodsoftime?Iftheproductunderassessmentrequirespotentmaterials,ensurethatthesupplierhaseffectivecontrolofexpiredorlesspotentmaterial.Ensurethatrequalificationprocessisadequatetoensurethepotencyofrawmaterial.Ifre-qualificationisinadequate,theanswerisNO.Ifpotencyisnotapplicabletotheproduction,theanswerisN/A.有没有正式的材料重新测试程序材料长时间存放后需要做测试300MS15Arerawmaterials,in-processandfinishedproductsadequatelydispositionedwhenfailingtomeetestablishedspecifications?Ensurethataprocessexistsforlabelingand(ifappropriate)quarantineofnonconformingmaterialexists.Ensurethatrecordsexisttodemonstratedispositionofnonconformingmaterial.Ifnoprocessorrecordsexist,scoreNO.对于不良品是否有合适的处理，确保不良品有合适的标识，有相关的记录来追踪不良品处理300MS16Isthereanadequateprogramtoestablishthequalificationsandreliabilityofsuppliersprovidingrawmaterialsiffulltestingisnotconductedonincomingrawmaterials?Suppliersmustbequalifiedbasedonsoundreasoning.Whatistheimpacttothefinalproduct?Howdoesthefactorysourcenewsuppliers?ThesequestionsmustbeassessedinordertoscoreaYES.如果不是对原材料进行ulltest,是否建立一个合适的程序300BASICGMPQuality-2018V3

MS17Doesthefactorydocumentandtracktheirsupplierreliability(performance)?Reviewfactory'ssupplierreliability/performancetrackingdocument.Recordsshouldin