版GMP验厂审核检查表.docx
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版GMP验厂审核检查表
RetailFactoryAuditReportNon-RegulatedBasic
GMP
QTReport:
AuditDates:
审核日期
ReportDate:
报告日期
FactoryName:
工厂名字
LeadAuditor:
审核组长
Address:
地址
Auditor（s）:
审核员
Fail
PassWith
Conditions
Pass
#Major
CAPAs:
Allprogramrequirementsforcertificatemet?
（rcpCert
Committeeonly）
#Minor
CAPAs:
Noncompliant
不符合
Marginal
警戒
Compliant
符合
CAPAfollow-uprequired?
NOYESnotrcp
FactoryGrade:
工厂等级
FactoryScore:
得分
0.00%
YES?
NO?
Products:
Scopeofaudit:
Mostrecentauditdate:
Whatentityperformedtheaudit?
Typesofcertificationsmaintained:
CompanyRepresentativeduringaudit:
Packaging
ProductionArea-Ft2:
#productionlines:
#Packaginglines:
Area-Ft2:
Warehouse-Ft2:
TotalPlantSize-Ft2:
COMPLETESECTIONBELOWFORCAPAFOLLOW-UPONLY
FactoryScore:
QTReport:
AuditDates:
IReportDate:
Fail
PassWithConditions
Pass
#MajorCAPAs:
Allprogramrequirementsforcertificate
Noncompliant
Marginal
Compliant
#MinorCAPAs
met?
（RCPCertCommitteeonly）
FactoryGrade:
Re-Auditrequired?
NOYESnotrcp
#
BASICGMPREQUIREMENT/CRITERIA/REFERENCE
GMP要求/标准惨考
Total
PossibleScore
最高可能得分
Points
Scored
实际得分
Yes/No
是/否
Majoror
minor
主要/轻微
FacilitiesandEquipment厂房/设备
FE1
Isthefacilityclean（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）
2
0
0
FE2
Aretherewrittenproceduresaddressingthemaintenanceof
thefacility?
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
2
0
0
FE3
Istherealistofapprovedchemicalsformaintainingthesanitationofthefacility?
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MSDS数据。
如果发现任何没有在清单中的化学品，或则没有MSDS,答案就应该是“No”
1
0
0
FE4
Isstorageofchemicalsusedinthefacilityadequate?
Ensurethatall
chemicalsarestoredinamannerconsistentwiththeinstructionspertheirMSDSsheets.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”
3
0
0
FE5
Isthefacilityinsatisfactorystructuralcondition?
NoRodentEntry
Points,NobrokenGlassorWindows,Ceilingdoesnotindicatewaterdamageorstructuraldefects.
3
0
0
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。
FE6
Iswastematerialhandiedappropriately?
Ensurethedumpsterareasare
cleanandwellorganized.Externalwasteisnotexcessive.
肥料处理是否合适，垃圾桶附近干净整洁。
1
0
0
FE7
Isthedesignofthefacilityadequatetoallowforsmoothflow
ofmaterialsandreducepotentialforcontamination?
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
2
0
0
FE8
Arethereadequateenvironmentalcontrolsforthebuilding?
Ifthe
productunderassessmentrequiresenvironmentalcontrols,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。
3
0
0
FE9
Isthelightingadequateforthebuilding?
建筑内部照明是否充足
1
0
0
FE10
Isthepestcontrolprogramadequate?
Ensurethatacontractexiststhat
documentsaregularlyscheduledpestcontrolserviceprogram.Thecontractpackageshouldincludeataminimum:
a）writtendocumentationregardingtheserviceperformedandtypeofmaterialsused;b）acurrentmapindicatingthelocationsofallrodenttraps;c）copiesofthelicensesandcertificatesofinsuraneeforthepestcontrolcompanyandcurrentlicenseforinspectors.
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
3
0
0
FE11
Arethewashroomsandtoiletscleanandingoodworking
order?
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
3
0
0
FE12
Isanorganizedsparepartsinventorykeptonhandatthe
factory?
Lookforaroomorareaseparatefromproductionthatcontainssparepartsfortheproductionequipment.Doesnotneedtobeallspareparts,
1
0
0
1
butataminimumshouldbecriticalpartsneededtokeeptheequipment
running.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
TOTALSCOREFORTHISSECTION
25
0
0
QualitySystem
品质系统
OrganizationandPersonnel
组织和人员
QS1
IsaTableofOrganization（ToO）availablefor
review?
Current?
Approved?
Controlled?
MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.
组织架构图？
最新，有批准和受控
2
0
0
QS2
Isqualityassuraneeindependentofmanufacturing?
Ensurethatthe
ToOdescribesseparationofmanufacturingauthorityandqualityassuranee
authority.
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
2
0
0
QS3
Areuptodatebiographies（CVs）availableforsupervisorypersonnelshownontheToO?
主管以上人员必须要简历保存
1
0
0
QS4
Doesthequalitydepartmenthaveadequatecoverageduring
allshifts?
Reviewlast30daysofshiftschedules.Foreveryproductionshift,
theremustbedocumentedQCcoveragetoscoreaYES.
*Guidanee:
“DocumentedQCCoverage”maybedemonstratedthrougha
combinationofbothofthefollowingpractices:
1）Designationof“Qu
Responsible”operator（s）duringa2ndor3rdshift.Thisisacceptablesolong
asverificationoftrainingmaybeprovidedandconclusiondrawnthat
designated“QualityResponsible”operatorshalveeducation,experienee
andknowledgetoactintheroleofQC.2）Thevendormusthaveprocedure
andrecordstoensurethatQAreviewsandreleasesallbatchespriorto
shipment.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：
1）每班有指定合格的品质负责人，且品质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前qa检查每批货物。
ality
3
0
0
QS5
IsthereawrittenprocedureforgeneralGMPtraining?
Thisshouldbea
procedureorotherdocumentsdefiningfrequencyoftraining,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
1
0
0
QS6
Aretrainingrecordsavailableforindividualsrandomly
selected?
Randomlyselectanappropriatesamplebasedonthesizeof
operationtoverifytrainingrecordsexist.Ifnorecordexistsforsampled
1
0
0
employees,scoreNO.
随机检查培训记录
QS7
Dotrainingrecordscontainnames（trainer/trainee）,dates
andsubjectmatter?
Alsoensuretherecordsdemonstrateconformaneewith
theproceduretoscoreYES.
培训记录是否报考名字（讲师和学员），日期和培训主题。
2
0
0
QS8
Isthereasufficientmeansforverifyingtrainee
comprehension?
Reviewthemethodoftrainingverification.Ensurethatitis
appropriatetotheextentofresponsibilityfortheproduct.
是否有合适培训效果确认方法
2
0
0
QS9
Aresatisfactorytrainingmaterialsavailablefor
review?
Slides,handouts,otherdocumentationtodemonstratetrainingprovidedconformstoprocedure.
是否有合适的培训材料，幻灯片，印刷材料
1
0
0
QS10
DoGMPtrainingmaterialsadequatelyaddressfacilitysanitation,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
2
0
0
QS11
Doemployeespracticesanitationandhygieneinthemanufacturingoperations?
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
3
0
0
QS12
Areonthejob（OTJ）trainingrecordsavailablefor
individualsrandomlyselected?
Specificallyverifyanyemployee
observednotfollowingsanitationandhygienepoliciestodetermineifthey'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
2
0
0
QS13
AreOTJtrainingrecordscompleteandadequate?
Containsnames
（trainer/trainee）,datesandsubjectmatter,specificrefereneetomachine,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
2
0
0
QS14
AreSOPsavailableforreview?
SOPsshouldcoverallcriticalproces
升级会员 