国外供应商审计GMPQuestionna.docx

国外供应商审计GMPQuestionna.docx

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国外供应商审计GMPQuestionna

COMPANYPROFILE

SUPPLlER:

DATE:

2004-06-16

ADDRESS:

____________________________________

PLANTSITETELEPHONE:

PLANTSITEFAXNUMBER:

MAINOFFICETELEPHONE:

）

Nameandaddressofparentorganization,ifapplicable

____________________________________________________________________________

PlantManager:

____________________________________________________

QA/QCManager:

_________________________________________

ProductionManager:

__________________________________

R&D/TechnicalServices___________________________________________

Materialsthatwillbeprovided:

Answerstoquestions:

AsourCompanyissendingthisquestionnairetoallitssuppliers,someofthequestionsmaynotberelevant,inwhichcasepleasemarkthecommentboxwithN/A（notapplicable）.

No.

GENERAL

YES

NO

COMMENTS

1.

IsthefacilityISOcertified?

Ifso,whichstandardandsincewhen?

2.

Doyouhaveawrittentrainingprogramforallemployees?

DoesthisincludecGMPtraining?

Pleaseindicatehowmanyshiftsareatthemanufacturingfacility

3.

Aretrainingrecordsmaintainedforallemployees?

Ifsohowlongarethetrainingrecordskept?

4.

Doemployeesworkingincertainareasspecialisedtraining（i.e.Laboratories,classifiedareas,packaging）?

5.

Isthetrainingcompetencybased?

6.

Arethereproceduresandcontrolsinplacetoensurecross-contaminationdoesnotoccurofmaterialsbeingstoredortransportedinreusablecontainers?

7.

Aretheenvironmentalconditionsadequateforrawmaterialandfinishedgoodstoensurematerialstability?

8.

Arepersonnelsuitablydressedwherealackofsuitableattirecouldadverselyaffecttheproduct?

9.

Isyourwarehousetemperaturecontrolledandormonitored?

10.

Dothefacilitiesprovideadequatespacetopreventmixes?

11.

Aretherecleaningproceduresforthefacilityandacleaningschedule?

12.

Isthereaninsectandrodentcontrolprogram?

DoyouhaveaSOPforpestcontrol?

13.

Areanyofthefollowinghandledatyourplant?

:

Antibiotics（ifyes,whattype）

hormones,steroids

cytotoxics,pesticides/insecticides?

No.

GENERAL

YES

NO

COMMENTS

14.

IsthereanHVACsystem?

Ifyes,hasitbeenqualified?

15.

Aretheenvironmentalconditionsproperlycontrolledanddocumented,whereappropriate?

Pleasebrieflydescribeyoursite’senvironmentalmonitoringprogramandpreventivemeasurestakentopreventcross-contaminationatpointsofmaterialexposure.

16.

Isthereperiodicdocumentedinspectionoftheseenvironmentalcontrolstoverifythatthesystemisfunctioningproperly?

17.

Doesthecompanyhaveaninternalwaterpurificationsystem?

Whatisthesourceoftheincomingwater?

Iftheincomingwaterispotable,istestingperformed?

18.

Doyouhaveaprogramforroutinewatermonitoring?

19.

DoyouhaveaSOPfortheOperationandMaintenanceoftheWaterSystem?

20.

Iscalibrationprograminplace?

21.

IsallQCandProductionmeasurementequipmentroutinelychecked,calibrated,andinspectedaccordingtoawrittenprocedure?

Dothecalibrationproceduresprovidespecifictoleranceranges?

22.

Arethecalibrationsperformedinternallyorbyanexternalcalibrationcompany?

23.

Isthecalibrationdate,thecalibrator,andthenextcalibrationdaterecordedanddisplayed,orarerecordscontainingsuchinformationreadilyavailableforeachpieceofequipmentrequiringcalibration?

No.

GENERAL

YES

NO

COMMENTS

24.

Arethecalibrationproceduresformalisedandaretraceabletoappropriatestandards?

25.

DoyouhaveanapprovedSOPforpreventiveMaintenanceofallcriticalequipmentandinstrumentation?

26.

Ismeasurementequipmentthathasgonebeyondthecalibrationcycleremovedfromserviceuntilsuchcalibrationisperformed?

27.

Wheremaintenanceofequipmentisnecessarytoassuremanufacturingspecificationsaremet,isthereawrittenscheduleformaintenance,adjustment,andcleaningofequipmentwhichisadheredto?

28.

Isthisschedulevisiblypostedonorneareachpieceofequipment,orisitreadilyavailabletopersonnelperformingmaintenanceactivities?

29.

Isthereawrittenrecordmaintained,documentingwhenmaintenanceinspectionactivitiesareperformedtoassureadherencetoapplicableequipmentmaintenanceschedules?

30.

Areanyinherentlimitationsorallowabletolerancesvisiblypostedonornearequipmentrequiringperiodicadjustmentsorreadilyavailabletomaintenancepersonnel?

31.

Aretherewrittenproceduresfortheuseandremovalofmanufacturingmaterials（e.g.lubricantorcleaningsolutions）fromtheproductorisitlimitedtoaspecificamountthatdoesnotadverselyaffecttheproduct'sfitnessforuse?

32.

Iscleaningvalidationinplacefortherelevantequipment?

Ifyes,didthisincludebothrinseandswabsamples?

33.

DoyouhaveaSOPforcleaningeachpieceofequipment（i.e.tanks,reactors,fluidbeddryers,hoses,connectors,ancillaryequipment）?

No.

GENERAL

YES

NO

COMMENTS

34.

Arecleaningrecordsmaintainedforeachpieceofequipment?

Ifso,howlongarethecleaningrecordskept?

35.

Istherealistofapprovedrawmaterialssuppliers?

36.

Arethereproceduresinuseforthereceiptofpurchasedmaterials?

37.

Aretherewrittendispositioncriteriaandproceduresfortheacceptance/rejectionofrawmaterials?

38.

AreCertificatesofAnalysisprovidedwitheachshipmentandifso,aretheyperiodicallychallenged?

39.

Iftherawmaterialcannotbesampledduetohazardorinstability,doesthesupplierprovideananalysisreport,whichshowsconformancetoappropriaterequirements?

40.

Arerawmaterialsinspected,sampledandtestedforconformancetospecifications?

41.

Aretherewrittenrawmaterialsamplingandtestingprocedures?

42.

Arerawmaterialinspectionanddispositionrecordskeptforaperiodoftime?

Howlong?

43.

Doesthesupplierretainrawmaterialsamplesandforhowlong?

44.

Arerawmaterialsawaitinginspectionsegregatedfromalreadydispositionedmaterial?

45.

Areallobsolete,rejected,ordeterioratedrawmaterialsclearlyidentifiedandsegregatedfromacceptedmaterials?

No.

GENERAL

YES

NO

COMMENTS

46.

Isaformalapproveddispositionfordamagedproductsissued?

47.

Arerecordsadequatefortraceabilitytosupplier'sidentification?

48.

Istheproductionalwayscarriedoutinthesameplantandsamemachine?

49.

Doyouworkbasedoncampaigns?

50.

Doesthebatchnumberreflectonehomogeneousproductionrun?

Ifreprocessingisnecessary,isthisreflectedinthelotnumber?

51.

Ifdryingisperformedinseveralsublotsarehomogeneitybetweenthesublotsverified?

52.

Doesthesynthesis-manufacturingprocessutilizeare-cycling（recovery）step?

（i.e.solvents,motherliquorsrecovering…）

Ifsolventsarerecycledhowmanyrecyclingsareallowed?

53.

IsthereamasterbatchrecordforeachAPIdetailingallthematerials,weights,temperaturesandproductionstepsforthesynthesis/manufacturingprocess?

DoestheBatchrecordspecifytheamountoftimeallowedbetweensuccessiveproductionsteps?

Arethetemperaturechartsfromeachprocessingstep（i.e.mixing,hydrogenation,isomericseparation,drying）includedintheBatchRecord?

54.

Areproceduresdocumented?

55.

IsthereanapprovedSOPforinprocesscontrolsforeachstageofthemanufacturingprocess?

Atwhatstagesoftheprocessareinprocesssamplestaken?

56.

Areyieldcalculationsperformedandmaterialsreconciliationmadeatdifferentstages?

Pleasedescribe

57.

IsthereaChangeControlSOPgoverningchangesinprocess,equipmentorsystems?

No.

GENERAL

YES

NO

COMMENTS

58.

Ifyes,whomustapprovepriortomakingthechange?

Whoapprovesrevisionstothemasterproductiondocuments?

Whoapprovesrevisionproductspecifications?

59.

IstheOAManualand/orInspectionPlanapprovedbyCompanyManagement?

60.

AreperiodicinternalauditsoftheQAprogramconductedtoverifycompliance?

61.

AretheresultsoftheauditsdocumentedandreviewedbyManagement?

62.

DoestheQA/QCunithavefinalauthoritytoacceptorrejectmaterials?

63.

Isthereawrittenagreementwherebythesupplieragreestonotifythemanufacturerofanyproposedchangeinrawmaterialand/ormanufacturingprocess?

64.

Arequalityhistoryrecordskeptforeachsupplier?

65.

Areanyoftherawmaterialsobtainedthroughreclamationorrecycledprocesses?

66.

Arerawmaterialsassignedanexpirationdates?

67.

Istheretraceabilitytorawmateriallot#'sthroughthemanufacturingprocess?

68.

Doyounotifycustomersofanyssignificantchangetoyourprocess?

69.

Aretherewrittenspecificationsand/orproceduresdescribingin-processtesttobeperformed;sampling,andtestmethods?

70.

Areinprocessassemblyandinspectiontestresultsdocumented?

71.

Isnon-conformingmaterialpromptlyidentifiedandsegregated?

72.

Arethereproceduresandcontrolstopreventcross-contaminationbetweenlotsandaretheseproceduresdocumented?

No.

GENERAL

YES

NO

COMMENTS

73.

Arematerialsproperlylabelledtoprecludeerrorinissuance?

74.

Arethereproceduresforthecontrolandissuanceofmaterial?

75.