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Auditing

AuditingGuide

Annex2–AideMémoire

Company :

Auditor（s） :

Location,Country :

DateofAudit:

GeneralRemark

Chapters1to19ofthisAideMémoirerefertotheappropriatechaptersofICHQ7（GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients）.Chapter20relatestoaspectsofQualityManagementSystemsaccordingtoISO9001orICHQ10PharmaceuticalQualitySystem.

1

Introduction

1.3

Scope

HasthecompanydesignatedthepointatwhichtheproductionoftheAPIbegins?

Canarationalebeprovidedforthisdecision?

Hasthedecisionbeendiscussedwiththerespectiveauthority?

Arethequalitycriticalstepsidentified?

2

QualityManagement

2.1

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

DesignandConstruction

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?

5.2