欧洲GMP药品现场检查项目表Word文件下载.docx
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欧洲GMP药品现场检查项目表Word文件下载.docx
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Whilethechecklististoguidetheauditor,isnotintendedtobeasubstituteforknowledgeoftheGMPregulations.
Althoughasinglequestionmaybeincludedaboutanyrequirement,theanswerwillusuallybeamulti-partonesincetheauditorshoulddeterminetheaudittrailforseveralproductsthatmayusemanydifferentcomponents.Enterdetailsinyournotebookandcrossreferenceyourcommentswiththequestions.
Atleastthreeproductionbatchesshouldbeselectedforthoroughanalysistoinclude:
(a)traceabilityofallcomponentsormaterialsusedinthesubjectbatches,(b)documentationofrawmaterialorcomponent,in-process,andfinishedgoodstestingforthesubjectproductbatches,(c)warehousinganddistributionrecordsastheywouldrelatetoapossiblerecall.
Responsesenteredonthechecklistshouldbeconsistent."
X"
isrecommendedfor"
NO"
;
acheckmarkfor"
YES"
"
n/a"
fornotapplicabletoquestionsthatdonotapply.Anasteriskandnotebookpagenumbershouldbeenteredonthechecklisttoidentifywhererelevantcommentsorquestionsarerecordedinyournotebook.
Thenotebookusedshouldbealaboratory-typenotebookwithboundpages.thenotebookshouldbeclearlylabeledastotheaudittype,date,andauditor(s).Manyauditorsprefertouseanotebookforasingleauditsoitmaybefiledwiththechecklistandthefinalreport.
ThereferencestosectionsintheGMPregulationareforyourconvenienceshouldaquestionarise.Insomeinstances,twoormoresectionswithintheGMPregulationmayhavebearingonaspecificsubject.TheheadingsintheGMPregulationwillusuallyoffersomeguidanceontheareascoveredineachsection.
Ageneralsuggestionforasuccessfulauditistospendmostofyourtimeonmajorissuesandasmallerportionofyourtimeonsmallissues.theremaybeobservationsthatyoumaywishtopointouttosupervisorypersonnelthatdeserveattention,butdonotbelonginanauditreportbecausetheyarerelativelyinsignificant.Bythesametoken,toomanysmallitemssuggestsatrendofnon-complianceanddeserveattentionassuch.Whencitingthese,bespecific.
Question
Instructions/questions(noteanyexceptionsandcommentsinnotebook).
Yes,No,orNA
DocumentN°
archivingarea
GeneralControls
Doesthefacilityanditsdepartments(organizationalunits)operateinastateofcontrolasdefinedbytheGMPregulations?
Organizational&
ManagementResponsibilities
Doesthisfacility/businessunitoperateunderafacilityorcorporatequalitypolicy?
DoesaQualityAssuranceunit(department)existasaseparateorganizationalentity?
DoestheQualityAssuranceunitalonehaveboththeauthorityandresponsibilitytoapproveorrejectallcomponents,drugproductcontainersandclosures,in-processmaterials,packagingmaterials,labellinganddrugproducts?
DoestheQAdepartmentorunitroutinelyreviewproductionrecordstoensurethatprocedureswerefollowedandproperlydocumented?
Areadequatelaboratoryspace,equipment,andqualifiedpersonnelavailableforrequiredtesting?
Ifanyportionoftestingisperformedbyacontractor,hastheQualityAssuranceunitinspectedthecontractor’ssiteandverifiedthatthelaboratoryspace,equipment,qualifiedpersonnelandproceduresareadequate?
Dateoflastinspection:
____________________
AreallQAproceduresinwriting?
AreallQAresponsibilitiesinwriting?
AreallwrittenQAprocedurescurrentandapproved?
(Reviewlogofprocedures)
Aretheproceduresfollowed?
(Examinerecordstoensureconsistentrecord-keepingthatadequatelydocumentstesting.)
AreQAsupervisorypersonnelqualifiedbywayoftrainingandexperience?
AreotherQApersonnel,.,chemists,analysts,laboratorytechnicians)qualifiedbywayoftrainingandexperience?
DocumentControlProgram
DoestheQAunithaveapersonordepartmentspecificallychargedwiththeresponsibilityofdesigning,revising,andobtainingapprovalforproductionandtestingprocedures,forms,andrecords?
DoesawrittenSOP,whichidentifieshowtheformistobecompletedandwhosignsandcountersigns,existforeachrecordorform?
Istheproductionbatchrecordandreleasetestresultsreviewedforaccuracyandcompletenessbeforeabatch/lotoffinishedproductisreleased?
EmployeeOrientation,QualityAwareness,andJobTraining
Circlethetypesoforientationprovidedtoeachnewemployee:
(1)Companybrochure
(2)LiteraturedescribingGMPregulationsandstressingimportanceoffollowinginstructions.(3)On-the-jobtrainingforeachfunctiontobeperformed(beforetheemployeeisallowedtoperformsuchtasks).(4)Other:
enterinnotebook.
DoeseachemployeereceiveretrainingonanSOP(procedures)ifcriticalchangeshavebeenmadeintheprocedure?
Indicatehowon-going,periodicGMPtrainingisaccomplished.
Isalltrainingdocumentedinwritingthatindicatesthedateofthetraining,thetypeoftraining,andthesignatureofboththeemployeeandthetrainer?
Aretrainingrecordsreadilyretrievableinamannerthatenablesonetodeterminewhattraininganemployeehasreceived,whichemployeeshavebeentrainedonaparticularprocedure,orhaveattendedaparticulartrainingprogram?
AreGMPtrainersqualifiedthroughexperienceandtraining?
Aresupervisorypersonnelinstructedtoprohibitanyemployeewho,becauseofanyphysicalcondition(asdeterminedbymedicalexaminationorsupervisoryobservation)thatmayadverselyaffectthesafetyorqualityofdrugproducts,fromcomingintodirectcontactwithanydrugcomponentorimmediatecontainersforfinishedproduct?
Areemployeesrequiredtoreporttosupervisorypersonnelanyhealthorphysicalconditionthatmayhaveanadverseeffectondrugproductsafetyandpurity?
Aretemporaryemployeesgiventhesameorientationaspermanentemployees?
Areconsultants,whoarehiredtoadviseonanyaspectofmanufacture,processing,packingorholding,ofapprovalforreleaseofdrugproducts,askedtoprovideevidenceoftheireducation,training,andexperience?
Arewrittenrecordsmaintainedstatingthename,address,qualifications,anddateofserviceforanyconsultantsandthetypeofservicetheyprovide?
PlantSafetyandSecurity
Doesthisfacilityhaveafacilityorcorporatesafetyprogram?
Aresafetyprocedureswritten?
Aresafetyprocedurescurrent?
Doemployeesreceivesafetyorientationbeforeworkingintheplantarea?
Issafetytrainingdocumentedinareadilyretrievablemannerthatstatesthenameoftheemployee,thetypeoftraining,thedateofthetraining,andthenameofthetrainerandthesignatureofthetrainerandtheparticipant?
Doesthisfacilityhaveaformal,writtensecuritypolicy?
Isaccesstothefacilityrestricted?
Describehowentryismonitored/restricted:
Isasecuritypersonavailable24hoursperday?
InternalQuality/GMPAuditProgram
Doesthisbusinessunit/facilityhaveawrittenqualitypolicy?
Isacopyofthisqualitypolicyfurnishedtoallemployees?
If"
yes"
toabove,whenprovided?
__________________
Istrainingprovidedinqualityimprovement?
DoesaformalauditingfunctionexistintheQualityAssurancedepartment?
DoesawrittenSOPspecifywhoshallconductauditsandqualifications(education,training,andexperience)forthosewhoconductaudits?
DoesawrittenSOPspecifythescopeandfrequencyofauditsandhowsuchauditsaretobedocumented?
DoesawrittenSOPspecifythedistributionoftheauditreport?
QualityCostProgram
Doesthisfacilityhaveaperiodicandformalreviewofthecostofquality?
Doesthisfacilityhavetheability,throughpersonnel,software,andaccountingrecords,toidentifyandcapturequalitycosts?
Doesthisfacilitymakeaconsciousefforttoreducequalitycosts?
DesignControl
NotdirectlyrelatedtotheDrugRegulation
FacilityControl
FacilityDesignandLayout
Areallpartsofthefacilityconstructedinawaythatmakesthemsuitableforthemanufacture,testing,andholdingofdrugproducts?
Istheresufficientspaceinthefacilityforthetypeofworkandtypicalvolumeofproduction?
Doesthelayoutandorganizationofthefacilitypreventcontamination?
EnvironmentalControlProgram
ThefacilityisNOTsituatedinalocationthatpotentiallysubjectsworkersorproducttoparticulatematter,fumes,orinfestations?
Aregroundsfreeofstandingwater?
Islightingadequateinallareas?
Isadequateventilationprovided?
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