不受限制的基本GMP审核检查表.docx
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不受限制的基本GMP审核检查表
不受限制的基本GMP审核检查表RetailFactoryAuditReportNon-RegulatedBasicGMP
BASICGMPREQUIREMENT/CRITERIA/REFERENCE
TotalPossibleScore
PointsScored
Yes/No
N/A
Major/Minor
COMMENTS
FacilitiesandEquipment
FE1
Isthefacilityclean（internal/external）?
Throughoutthecourseoftheassessment,observationofcleanlinessshouldbetaken.Cleanlinessshouldbedefinedasanenvironmentthatreducesand/oreliminatesthepotentialforcontamination.
2
FE2
Aretherewrittenproceduresaddressingthemaintenanceofthefacility?
PreventiveMaintenancepoliciesandschedulesshouldbedocumented.Recordsshouldbeavailableforreviewandshouldcontaininformationregardingdailypre-operationequipmentinspection,dailymonitoringofequipmentfunction,dailyhousekeepingactivities,sanitationactivitiesandanyothernecessaryactivitiestomaintainthesafetyandqualityofproduct.
2
FE3
Istherealistofapprovedchemicalsformaintainingthesanitationofthefacility?
Chemicalsusedforanyoftheaboveactivitiesshouldbedefinedwithintheapprovedproceduresandpolicies.MaterialSafetyDataSheetsshouldbemaintainedforallchemicals.AnappropriatesampleofchemicalsshouldbeselectedandMSDSrequestedforeach.IfanychemicalsareobservedinusewithoutapprovalorifanyofthechemicalsselecteddonothaveMSDSprovided,theanswerisNO.
1
FE4
Isstorageofchemicalsusedinthefacilityadequate?
EnsurethatallchemicalsarestoredinamannerconsistentwiththeinstructionspertheirMSDSsheets.Additionally,ensurethatthemethodofstorageisinsuchamannertoeliminateproductcontamination.AnswerisNOifstorageconflictswitheitherrequirementabove.
3
FE5
Isthefacilityinsatisfactorystructuralcondition?
NoRodentEntryPoints,NobrokenGlassorWindows,Ceilingdoesnotindicatewaterdamageorstructuraldefects.
3
FE6
Iswastematerialhandledappropriately?
Ensurethedumpsterareasarecleanandwellorganized.Externalwasteisnotexcessive.
1
FE7
Isthedesignofthefacilityadequatetoallowforsmoothflowofmaterialsandreducepotentialforcontamination?
2
FE8
Arethereadequateenvironmentalcontrolsforthebuilding?
Iftheproductunderassessmentrequiresenvironmentalcontrols,ensurethatthesupplierhascontrolledandverifiedtemperatureatcriticalareas.Ifenvironmentalcontrolisinadequate,theanswerisNO.Ifenvironmentalcontrolisnotapplicabletotheproduction,theanswerisN/A.
3
FE9
Isthelightingadequateforthebuilding?
1
FE10
Isthepestcontrolprogramadequate?
Ensurethatacontractexiststhatdocumentsaregularlyscheduledpestcontrolserviceprogram.Thecontractpackageshouldincludeataminimum:
a）writtendocumentationregardingtheserviceperformedandtypeofmaterialsused;b）acurrentmapindicatingthelocationsofallrodenttraps;c）copiesofthelicensesandcertificatesofinsuranceforthepestcontrolcompanyandcurrentlicenseforinspectors.Reviewarepresentativesampleofinspectionrecordsfromthelast12months.Ensurethatanypestproblemsnotedhavebeenaddressedandhadbeenaddressedpriortothenextinspection.Ensurethetraps/devicesaretraceableeitherbynumericallabeling,barcodingorothermethod.Ensurethatthepestcontrolinspectorhasinitialedorprovidedsomeotherdocumentationtosupportthatalltrapshadbeenproperlyinspected.Finally,toreceiveaYESforthisquestion,nosignofrodentactivitywasnotedduringthecourseofthisassessment.
3
FE11
Arethewashroomsandtoiletscleanandingoodworkingorder?
Clean,stockedwithAntibacterialSoapandsingleusenapkin/towel,runninghotwater.
3
FE12
Isanorganizedsparepartsinventorykeptonhandatthefactory?
Lookforaroomorareaseparatefromproductionthatcontainssparepartsfortheproductionequipment.Doesnotneedtobeallspareparts,butataminimumshouldbecriticalpartsneededtokeeptheequipmentrunning.Factoryshouldhaveinventorylist.
1
QualitySystem
OrganizationandPersonnel
QS1
IsaTableofOrganization（ToO）availableforreview?
Current?
Approved?
Controlled?
MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.
2
QS2
Isqualityassuranceindependentofmanufacturing?
EnsurethattheToOdescribesseparationofmanufacturingauthorityandqualityassuranceauthority.
2
QS3
Areuptodatebiographies（CVs）availableforsupervisorypersonnelshownontheToO?
1
QS4
Doesthequalitydepartmenthaveadequatecoverageduringallshifts?
Reviewlast30daysofshiftschedules.Foreveryproductionshift,theremustbedocumentedQCcoveragetoscoreaYES.
*Guidance:
“DocumentedQCCoverage”maybedemonstratedthroughacombinationofbothofthefollowingpractices:
1）Designationof“QualityResponsible”operator（s）duringa2ndor3rdshift.Thisisacceptablesolongasverificationoftrainingmaybeprovidedandconclusiondrawnthatdesignated“QualityResponsible”operatorshavetheeducation,experienceandknowledgetoactintheroleofQC.
2）ThevendormusthaveprocedureandrecordstoensurethatQAreviewsandreleasesallbatchespriortoshipment.
3
QS5
IsthereawrittenprocedureforgeneralGMPtraining?
Thisshouldbeaprocedureorotherdocumentsdefiningfrequencyoftraining,generalscopeoftraining,trainingproviderandmethodologyfordeterminingcompetency.
1
QS6
Aretrainingrecordsavailableforindividualsrandomlyselected?
Randomlyselectanappropriatesamplebasedonthesizeofoperationtoverifytrainingrecordsexist.Ifnorecordexistsforsampledemployees,scoreNO.
1
QS7
Dotrainingrecordscontainnames（trainer/trainee）,datesandsubjectmatter?
AlsoensuretherecordsdemonstrateconformancewiththeproceduretoscoreYES.
2
QS8
Isthereasufficientmeansforverifyingtraineecomprehension?
Reviewthemethodoftrainingverification.Ensurethatitisappropriatetotheextentofresponsibilityfortheproduct.
2
QS9
Aresatisfactorytrainingmaterialsavailableforreview?
Slides,handouts,otherdocumentationtodemonstratetrainingprovidedconformstoprocedure.
1
QS10
DoGMPtrainingmaterialsadequatelyaddressfacilitysanitation,personalhygiene,andrecordkeeping?
2
QS11
Doemployeespracticesanitationandhygieneinthemanufacturingoperations?
Duringthewalkthroughofproduction,storage,etc.observeemployeestoensureallsanitationandhygienepoliciesareimplemented.Ifobservationdeterminespoliciesarenotbeingfollowed,mustscoreNO.
3
QS12
Areonthejob（OTJ）trainingrecordsavailableforindividualsrandomlyselected?
Specificallyverifyanyemployeeobservednotfollowingsanitationandhygienepoliciestodetermineifthey'vebeenprovidedthetraining.
2
QS13
AreOTJtrainingrecordscompleteandadequate?
Containsnames（trainer/trainee）,datesandsubjectmatter,specificreferencetomachine,process,oractivity.
2
StandardOperatingProcedures/ChangeControlProgram
QS14
AreSOPsavailableforreview?
SOPsshouldcoverallcriticalprocessesutilizedforthecontrolledmanufactureofproduct（s）includedintheassessmentscopetoscoreYES.
3
QS15
AreSOPswritten,identifiedandapprovedinasatisfactorymanner?
Current?
Approved?
Controlled?
MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.
3
QS16
IsdistributionofnewandrevisedSOPsandretrievalofobsoleteSOPsadequate?
2
QS17
DodocumentedINSPECTIONproceduresorinstructionsexist?
Reviewinspectionproceduredocumentation.
1
QS18
AreSOPsreviewedperiodicallytoensuretheirapplicabilitytocurrentpractices?
1
QS19
Isthereadocumentedchangecontrolprocedureforplannedandunplannedchangestoproductionprocesses?
3
QS20
Arechangesrelatingtomanufacturing/packagingprocessesadequatelyapproved,wherenecessary?
ThesechangesshouldbeapprovedbytheresponsiblepartiesidentifiedinthechangecontrolprocedureindicatedabovetoscoreYES.
3
Documentation（Logbooks/BatchRecords）
QS21
Arelogbooksavailableforreviewwithrespecttoproduction?
1
QS22
Istheuseoflogbooksdetailedinawrittenprocedure?
1
QS23
Arelogbooksclearwithrespecttoactionstakenbyindividuals?
1
QS24
Dologbooksexhibitgooddocumentationpracticeswithrespecttochanges,legibilityandsequenceofevents?
Nowhiteout,scratchoutmarks,etc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.
1
QS25
Arelogbooksperiodicallyreviewedtoensuretheiradequacy?
1
QS26
Isthereanadequatewrittenprogramforthemaintenanceofproductionrecordsforeachfinishedproductmanufactured?
3
QS27
Dobatchproductionrecordscontainadequateinformationwithrespecttothepackagingoffinishedproducts?
Ensurepackaginglabels/informationincludeadequateinformationtosupportthatproductionrecordsareaccuratewithrespecttoidentification,quantity,weight,material,etc.
3
QS28
Dobatchproductionrecordscontaintherequiredinformationne
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