国外供应商审计GMPQuestionnaireWord格式.docx
- 文档编号:16541746
- 上传时间:2022-11-24
- 格式:DOCX
- 页数:17
- 大小:20.35KB
国外供应商审计GMPQuestionnaireWord格式.docx
《国外供应商审计GMPQuestionnaireWord格式.docx》由会员分享,可在线阅读,更多相关《国外供应商审计GMPQuestionnaireWord格式.docx(17页珍藏版)》请在冰豆网上搜索。
__________________________________
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?
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?
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)?
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?
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?
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?
73.
Arematerialsproperlylabelledtoprecludeerrorinissuance?
74.
Arethereproceduresforthecontrolandissuanceofmaterial?
75.
Arematerialsstoredandhandledinamannerdesignedtopreventdamage,mix-up,contamination,andotheradverseeffects?
76.
WhencomputersareusedasapartofanautomatedproductionorQAsystem
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 国外 供应商 审计 GMPQuestionnaire