Auditing文档格式.docx
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Auditing文档格式.docx
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Principles
2.11
ACertifiedQualityManagementSystem(e.g.ISO9001)isimplemented?
(ifyes,seechapter20)
2.12
Isthereaqualitypolicy?
Howisitbroughttotheattentionoftheemployees?
IsthereaQualityManualorequivalentdocumentationthatdescribesindetailhowtheQualitySystemisimplemented?
HowdoesManagementrevieweffectivenessofqualitysystem
2.13
IstheQualityUnit(QA/QC)independentofproduction?
2.14
Isthereanauthorizedperson(s)forthereleaseofIMandAPIs?
Whoistheperson(s)?
2.16
Arealldeviationsdocumentedandexplained?
Arecriticaldeviationsinvestigatedinatimelymanner?
Isthereawrittenprocedureforhandlinginvestigations(6.53)?
Averagedaysforcompletion?
2.17
HowisitensuredthatmaterialsarenotreleasedorusedbeforecompletionofevaluationbytheQU?
IfnotdonebyQU:
Isanappropriatesysteminplace?
2.18
HowismanagementnotifiedofseriousGMPdeficiencies,qualityrelatedcomplaintsand/orproductdefects?
Averagetimeneededforinformation?
2.2
ResponsibilitiesoftheQU
2.21
ArethereproceduresthatensurethatQUreviewsandapprovesallqualityrelateddocuments?
2.22
Non-transferableresponsibilitiesofQU:
-release/rejectionofAPIsandIM(tobesold)
-establishsystemtorelease/rejectmaterialsandlabels
-reviewofcriticalprocessstepsbatchrecords
-ensurecriticaldeviationsareinvestigated
-approvingspecificationsandmasterinstructions
-approvingallqualityrelateddocuments
-ensuringconductionofinternalaudits
-approvingcontractmanufacturers
-approvingchangeswithqualityimpact
-approvingvalidationdocuments
-ensurecomplaintsareresolved
-ensuringcalibrationsystemisfunctioningaccordingtoprocedureexecuted
-ensuringthatstabilitydataisgeneratedandreviewed
-performingproductqualityreviews
2.3
ResponsibilitiesforProductionActivities
-procedureforpreparing,reviewingandapprovinginstructions
-reviewingbatchproductionrecords
-ensurealldeviationsandinvestigationsarehandled
-cleaningoffacilities
-calibrationsperformed
-validationdocumentsgenerated
-evaluationofproposedchanges
-ensurethatfacilitiesandequipmentarequalified
2.4
InternalAudits
2.40
Areregularauditsperformed?
Isthereanauditschedule?
Istheschedulefollowed?
2.41
Areauditfindingsandcorrectiveactionsdocumented?
Proceduretonotifymanagementofauditfindings?
Arecorrectiveactionscompletedwithinagreedtime(aretheresignificantdelays?
)
2.5
ProductQualityReview
2.50
AreregularProductQualityReviewsconductedforallproducts?
Frequency(dedicated,campaign)?
Content(atleast):
-reviewofcriticalIPCandAPItestresults
-reviewofallbatchesfailed
-reviewofallcriticaldeviations
-reviewofprocesschangesandimpactonquality
-reviewofchangestoanalyticalmethods
-reviewofresultsofongoingstabilityprogrammes
-reviewofreturns,complaints,recalls
-reviewofadequacyofcorrectiveactionsdefinedinpreviousreview
2.51
Evaluationandassessmentforneedofadditionalcorrectiveactionstoaddressrecurringissuesand/orneedforprocessorcleaningrevalidation
3
Personnel
3.1
PersonnelQualifications
3.10
Adequatenumberofpersonnel?
Qualificationofpersonnelsufficientatdifferentlevels?
3.11
AreresponsibilitiesofallpersonnelengagedinmanufactureinAPIsinwritingavailable?
Areresponsibilitiesperiodicallyreviewedtoensuretheyarecurrent?
3.12
Isregulartrainingconducted?
Arerecordsoftrainingmaintained?
Iseffectivenessoftrainingevaluated?
How?
3.2
PersonnelHygiene
3.21
Dopersonnelwearcleanclothingsuitableforactivity?
Additionalprotectiveapparelwherenecessary(e.g.FinalProductPackingRooms)?
3.22
HowisitensuredthatpersonnelhavenodirectcontactwithIMandAPIs?
3.23
Howisitensuredthatnosmoking,drinking,chewingandstorageoffoodtakesplace?
3.24
Howarepersonnelwithinfectiousdiseasesoropenlesionsidentified?
Isthereaprocedureinplacethatthesepersonshavenoproductcontact?
3.3
Consultants
AreconsultantsusedtoadviseonanyGMPrelatedactivities?
Isthereanassessmentofconsultant’seducation,trainingandexperience?
4
BuildingsandFacilities
4.1
DesignandConstruction
4.10
Cancleaningandmaintenancebeeasilyperformedbasedondesignofequipmentandlayoutoffacility?
Haveproductionandwarehousefacilitiesbeendesignedtopreventcontaminationorcrosscontamination?
Ifnot,howiscontaminationprevented?
4.11
Isthereadequatespaceforplacementofequipmenttopreventmix-uporcontamination?
4.12
Outdoorequipmentraisesconcernsforcontamination?
4.13
Doesflowofmaterialsandpersonnelraiseconcernsforcontamination?
4.14
Definedareasorcontrolsystemsinplaceforthefollowingactivities:
-receipt,identification,samplingofincomingmaterials
-quarantinebeforerelease/reject
-SamplingofintermediatesorAPI’s
-holdingofrejectedmaterialsbeforefurtherdisposition?
-Packagingandlabelingoperations?
4.15
Washingfacilitiesandtoiletsavailableforpersonnel?
4.16
Laboratoryareasseparatedfromproduction?
4.2
Utilities
4.20
Allutilitiesthatcouldimpactonproductqualityareidentifiedandqualified?
Aretheutilitiesmonitoredandactionstakenwhenalertlimitsareexceeded?
4.21
Adequateventilation,airfiltrationandexhaustsystemsinplace?
Arethesesystemsdesignedandoperatedtopreventcontamination?
4.22
Controlofre-circulatedairsufficienttoavoidcontamination?
4.23
Permanentlyinstalledpipeworkappropriatelyidentified?
Ispipeworkmaintainedandlocatedinsuchawayastopreventcontamination?
4.24
Aredrainsdesignedtopreventback-siphonageormicrobiologicalcontaminationinareaswhereproductisexposed?
4.3
Water
4.30
Waterdemonstratedtobesuitableforintendeduse?
4.31
IsProcesswatermeetingdrinkingwaterqualityasaminimumstandard?
Isadditionalwatertreatmentsysteminplace?
Isqualityofallgradesofprocesswatermonitoredatpointsofuseforphysical/chemicalattributes,totalmicrobialcounts,objectionableorganisms?
Areactionstakenwhenlimitsareexceeded?
4.32
Tighterspecificationsneededtoensurequality?
Whatarethespecifications?
4.33
Validationoftreatmentof(higher)watertreatment?
4.34
Ifclaimsaremadeforsterileorparenteraluse:
Monitormicrobialcounts,objectionablemicroorganismsandendotoxins
4.4
Containment
4.40
Forhighlysensitizingmaterialsarededicatedproductionareas(facilities,airsystems,equipment)inuse?
4.41
Dedicatedproductionareaforhighpharmacologicalactivity
4.42
Aretheremeasurestopreventcross-contaminationfrompersonnel,materialsetc.forexamplemovingfromoneproductionareatoanother?
4.43
Productionofhighlytoxic,non-pharmaceuticalproducts,forexamplepesticidesexcludedfrompharmaceuticalproductionfacilities?
4.5
Lighting
Adequatelightingfore.g.cleaningandmaintenance
4.6
SewageandRefuse
4.60
Sewagetoberemovedtimely
4.7
SanitationandMaintenance
4.70
Buildingstobekeptproperlymaintained,repairedandcleaned
4.71
Writtenproceduresforcleaningforequipmentandfacilitiesinplace
4.72
Proceduresforpestcontrolinplace?
5
ProcessEquipment
5.1
5.10
Equipmentsuitablylocated,easytocleanandmaintain?
5.11
Equipmentsurfacesdonotalterproductquality
5.12
Equipmentonlyusedwithinthequalifiedoperationrange?
5.13
Majorequipmentandpermanentlyinstalledpipeworkidentified
5.14
LubricantsnotincontactwithIMandAPIs?
Otherwisefoodgradelubricantsused?
5.15
Precautions(measures)takenwhereequipmentisopenedtopreventcontamination?
Forexampleadditionofseedsorsampling
5.16
Arecurrentengineeringdrawingsavailableforequipment,installationsandutilitysystems?
5.2
EquipmentMaintenanceandCleaning
5.20
Preventivemaintenanceprogrammeinplace?
Schedulefollowed?
5.21
Writtenproceduresforthecleaningofequipmentinplace?
Dotheproceduresgivesufficientdetailtoenableoperatorstocleaneachtypeofequipmentinaneffectiveandreproduciblemanner?
5.22
Areequipmentandutensils,suchassamplingdevicescleaned,storedandwhereappropriatesanitizedorsterilizedtopreventcontaminationorcarry-overofamaterialthatwouldaffectthequalityoftheIMorAPI?
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