欧洲GMP药品现场检查项目表.docx

欧洲GMP药品现场检查项目表.docx

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欧洲GMP药品现场检查项目表

AuditChecklistforDrugIndustry

Disclaimer

ThefollowingchecklistisintendedtoaidinthesystematicGMPauditofafacilitythatmanufacturesdrugcomponentsorfinishedproducts.

Theadequacyofanyproceduresissubjecttotheinterpretationoftheauditor.Therefore,theauthoracceptsnoliabilityforanysubsequentregulatoryobservationsoractionsstemmingfromtheuseofthisauditchecklist.

InstructionsforUsingthisAuditChecklist:

Beforestartinganon-siteaudit,plantheaudit.Reviewpastaudits,noteindicationsofpossibleproblemareasanditems,ifany,thatwereidentifiedforcorrectiveactioninapreviousaudit.Ifyouarenotalreadyfamiliarwiththisfacility,learnthetypeofproductproducedhereandhowitisorganizedbypersonnelandfunction.Whatdoesyour"customer",.,yoursuperiororseniorfacilitymanagement,expecttolearnfromthisaudit?

Thechecklististobeusedwithanotebookintowhichdetailedentriescanbemadeduringtheaudit.

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?