21/10/2016

GoodDocumentationPractices|IVTJVT

SignIn|
Search

JVT

CHROMacademyVideoTrainingCourses

GoodDocumentationPractices|IVT
ByTimSandleOct1,20144:00amPDT

Abstract
TheeffectivecontrolandmanagementofdocumentationisacriticalpartoftheGMPprogramwithintheorganization.
Documentationcontrolisnotoptionalitisalegalrequirement.Anoverviewofgooddocumentationpractices
applicabletothoseworkinginthepharmaceuticalandhealthcaresectorsispresented.Specifictopicsfordiscussion
includedocumentationfundamentals,documentcreation,documentmanagement,bestpracticesinstyleandlayout,
completingdocumentsandrecordkeeping,electronicrecords,storage,errorsincludingerrorcorrection,andassociated
topics.Recommendationspresentedshouldcontributetodevelopmentofaneffectivesitedocumentationprogram.

Introduction
Theeffectivecontrolandmanagementofdocumentationisacriticalpartofthegoodmanufacturingpractice(GMP)
programwithintheorganization.Theaccuratecaptureofinformationplaysanimportantpartinthemanufactureof
pharmaceuticalsandmedicaldevices[1].GMPisthatpartofqualityassurancewhichensuresthatproductsare
consistentlyproducedandcontrolledtothequalitystandardsappropriatefortheirintendeduse[2].
TocomplywithGMP,facilitiesrequiredocumentedsystemsbasedonspecifications,manufacturingandpackaging
instructions,procedures,andrecords.Inparticular,specificbatchmanufacturingdocumentationmustbeinplace.
Thesedocumentsmustmakeitpossibletotracethehistoryofeachbatch.Thistraceabilityneedstobepossiblefora
minimumdefinedperiodthatistypicallyoneyearafterexpiryofthebatch.Thesetypesofrecordsareessentialforthe
qualityassurancesystem.
DocumentationisalsokeytoGMPcomplianceforitensurestraceabilityofalldevelopment,manufacturing,andtesting
activities.Documentationprovidestherouteforauditorstoassesstheoverallqualityofoperationswithinacompany
andthefinalproduct[3].Forexample,withtheFDACodeofFederalRegulations(CFR),21CFR211.180(e),recordsand
reports,states:"writtenrecordsshallbemaintainedsothatdatathereincanbeusedforevaluatingthequality
standardsofeachdrugproduct".ThisextracttherebylinkstheimportanceofgooddocumentationtoGMP.
Thispaperpresentsanoverviewofgooddocumentationpracticesapplicabletothoseworkinginthepharmaceutical
andhealthcaresectors.Specifictopicsfordiscussionincludethefollowing:
Goodmanufacturingpracticeanddocumentationincludingerrorsanderrorcorrection
Documentfundamentals
Documentcreation
Documentmanagement
Typesofdocuments
Bestpracticesfordocumentcreation,includingstyleandlayout
Completingdocumentsandrecordkeeping
Electronicrecords
Documentstorage

GoodManufacturingPracticeandDocumentation
ThereareanumberofaspectsofGMPthatrelatetodocumentation.GMPrequiresthatdocumentsshouldbe:
Controlledwithinthequalitysystem
Approved,signedanddated
Regularlyreviewed
Retained,and
Canbesupersededwithinthequalitysystem.
Pharmaceuticalandotherhealthcareorganizationmusthave"good"documentationpractices.Whethertheterm"GDP'
shouldbeusedtorepresent"gooddocumentationpractice"iscontentioussinceGDPismorecommonlyusedasan
acronymfor"gooddistributionpractice"'inrelationtothedistributionofmedicinalproducts.

TypesofDocumentation
Documentationreferstobothprintedformsandelectronicsystems.Broadlyspeaking,documentationtypescanbe
classifiedas:
Specifications
Manufacturingandpackaginginstructions
Standardoperatingprocedures
Records.
Morespecifically,thevarioustypesofdocumentsfoundwithinatypicalpharmaceuticalorganizationinclude:
Technicalagreements
Confidentialityagreements
Technicalreports
Qualitysystemrelateddocuments

http://www.ivtnetwork.com/article/gooddocumentationpractices

1/7

21/10/2016

GoodDocumentationPractices|IVTJVT
QualityManual
SOP's
Validationprotocolsandreports
Deviationreports
Auditplans
ValidationMasterPlansandvalidationdocumentsincludingURS,DQ,FAT,IQ,OQ,PQ,andValidationreports
Testmaterialrelateddocumentsincludingproductspecification,testmaterialreceipt,andreports
Personnelrelateddocumentsincludingtrainingrecords
Facilityrelateddocumentsincludingfloorplans,HVACplans,andenvironmentalspecifications
Deviationformsincludingunplanneddeviationsandsystemfailureinvestigation
Changecontrol
Worksheets,notebooks,andlogbooks
Documentationmustbeclear,freefromerrors,subjecttoregularreview,andbekeptuptodate.

Responsibilities
GMPrequiresthatthemanagementofeachfacilitydefinesresponsibilityfororigination,distribution,maintenance,
changecontrol,andarchivingofallGMPdocumentationandrecordswithinagivendepartmentorunit.Atthe
departmentallevel,documentownersarerequiredtoensureacceptabilityofallaspectsofdocumentationandrecords
management.Thedocumentationsystemsshouldbeauditedperiodicallybythequalityassurancefunction.Despite
controlsystemsandapplicationoftheauditprocess,regulatorsfrequentlycitedocumentationerrorsandpoorpractices
atinspection.

DocumentErrors
CommondocumentationerrorsthatcommonlyappearinFDAwarninglettersandreportsfromotherregulatory
authoritiesinclude[4]:
Documentationnotcontemporaneous
Useofdittomarks
Useofsignaturestamp
Failuretouseinkasspecifiedbyprocedure
Incorrectinkusedforentriescausingillegibledatawhenasubstancewasspilled
Logbookcorrectionsfailedtoidentifypersonwhomadethechanges
Obscuredoriginaldata
Useofpencil
Inaccuraterecords
Samplesequencetableandaudittrailnotdocumented(todrawonthecommonlyusedphrase:"ifitisnot
documented,itdidn'thappen")
Handwrittenchangesnotdated
Writeovers,multiplelinethrough,anduseof"whiteout"orothermaskingdevice.
ThemostcommonGMPcitationoccurswithcorrectionoferrorswheninformationisrecorded.Correctionof
documentationerrorsshouldinclude:
Drawasinglelinethroughtheerror,
Makethecorrectionnexttotheerror,
Writeanexplanationfortheerror,
Signanddatethecorrection.
Itisrecommendedthatthesecommonerrorsarehighlightedintrainingonthecreationanduseofdocumentation.

DocumentFundamentals
Therearemanydifferenttypesofdocumentsfoundwithinpharmaceuticalorganizations,eachservingadifferent
purpose[5].Althoughtherearedifferentdocumenttypes,documentscangenerallybeplacedintoasmallnumberof
categoriescascadingdownthequalitysystem.
Withthetypesofdocumentsandsomeoftheerrorsrelatingtodocumentationuse,itisusefultoconsideratthispoint
howdocumentscometogetherandwhatthebasicsofadocumentare.ThisisillustratedinFigure1.

http://www.ivtnetwork.com/article/gooddocumentationpractices

2/7

21/10/2016

GoodDocumentationPractices|IVTJVT

Figure1:ClassicDocumentationHierarchy
Thevastmajorityofdocumentsareproceduresorrecords.Themostcommonexamplesofaprocedurewithinthe
pharmaceuticalorganizationarestandardoperatingprocedures(SOP)[6].ArecordisoftenrelatedtoaspecificSOP
andcarriestheconfirmatorydetailsrequiredofthatSOP.Forexample,theSOPforasterilitytestrecordshould
requiredetailssuchastheproductname,itsbatchnumber,anditstestresult.

DocumentCreation
Thecreationofdocumentationcanbeconceivedverymuchlikeaprocess.Indoingso,thefirststagecanbedescribed
aseventcapture.However,theinformationoreventhasnostatusunlessitcanbeverifiedorapproved,whichisthe
secondstage.Thelastpartoftheprocessistocommunicatetheevent,inthiscontextbycirculatingandimplementing
thedocument.Toillustratethisconsideralaboratorytestcommontomanymicrobiologylaboratoriesthegramstain
technique.Todocumenttheprocedure,weneedtowritedownthestepswhichcapturetheprocess.Aspartofa
controlledsystem,thestepsneedtobeverifiedasbeingcorrectandtheprocedure"signedof"(approvalstage).The
procedurecanthenbeissuedinintoroutineusealongwithassociatedtraining,whichisthecommunicationstage.

Figure2:DocumentationFlowPath

DocumentManagement
Eachpharmaceuticalorganizationshouldhaveasystemfordocumentationmanagement.Thissetsouttherulesand
mechanismsforcreatingandcontrollingadocument.GMPmakescertainrequirementsofadocumentationsystem
suchas:
Assigningresponsibilitytoanindividualforcontrolofthesystem
Ensuringlayout,approval,authorizationanduniqueidentificationofalldocumentsisprovidedforoftenbya
masterdocumentationSOP
HavingamasterdocumentationSOPtoinclude:
Proceduresforissue,retrieval,reissue,maintenanceofcurrencyandtraceability
Proceduresfordeterminingtheneedfordocuments
Identificationofdocumentstobeincludedinbatchdossiers(forbatchrelease)
Linkageofdocumentstolicensesandregulatoryrequirements
Outliningauditrequirementsforthedocumentationsystem
Ensuringthatonlythemostuptodateversioniseverused
Retentiontimesandarchiving.

DocumentControl
Furtherconsiderationsregardingthesystemcontrollingdocumentationinclude:
Documentsshouldbeavailableatpointofuse
Masters,includingelectronicversions,areheldundercontrol
Thereiscontroloverformat
Thereisasystemforchanges,approval,andreissue
Thereiscontrolofdocumentsofanexternalorigin.
Themajorityoftheserequirementsalsomakeuptheelementsofthe"documentationlifecycle"Fromdocument
creation,throughitsuse,toitsstorageandarchiving,andthentoitseventualretirementandpossiblyreplacementby
arevisedversion.
Thecontrolofdocumentsnecessitatesthefollowingsteps:

http://www.ivtnetwork.com/article/gooddocumentationpractices

3/7

21/10/2016

GoodDocumentationPractices|IVTJVT
1.Documentationcreation
Documentsmustbecontemporaneouswiththeeventtheydescribe
Documentsmustnotbehandwritten(exceptforhandwrittenentries)
Whenelectronicallyproduced,thedocumentationmustbecheckedforaccuracy
Freefromerrors
Forsometypesofdata,thedocumentationmustbeinaformatthatpermitstrendevaluation.
2.Documentapproval
Documentsmustbeapprovedforuse.Theymustbeapproved,signed,anddatedbyappropriate
authorizedpersonnel.
3.Handwrittenentries
Adequatespaceneedstobeprovidedforexpectedhandwrittenentries
Handwrittenentriesmustbeinindelibleink
Criticalentriesmustbeindependentlychecked(secondpersonverified)
Nospacesforhandwrittenentriesshouldbeleftblank.Ifunused,theyarecrossedoutor"n/a"(or
similartext)entered
Dittomarksorcontinuationlinesarenotacceptable
Astampinlieuofahandwrittensignatureisnotacceptable.
4.Documentcopies
Copiesneedtobeclearandlegible
Errorsmustnotbeintroduced
Documentsshouldberegularlyreviewedandkeptcurrent,
Documentsshouldberetainedandreadilyavailableforaudits
Archiveddocumentsmustberetrievablefortheappropriateduration
Electronicdocumentmanagementsystemsmustbevalidated
Electronicrecordsmustbebackedup.
5.Documentmodification
Handwrittenmodificationsaresignedanddated
Alteredtextshouldnotbeobscured(e.g.,noobliteratingthetextthroughcrossingout)
Whereappropriate,thereasonforalterationmustbenoted(forexample,"e.e."isacommon
abbreviatedreason,indicating"entryerror"),
Controlsexisttopreventtheinadvertentuseofsupersededdocuments
Electronicversionsshouldonlybemodifiedbyauthorizedpersonnel
Accesstoelectronicdocumentsmustbecontrolledbypasswordorothermeans.
Ahistory(audittrail)mustbemaintainedofchangesanddeletionstoelectronicdocuments.Welldesigned
documentationandappropriatedocumentationareparamount.Itisnecessarytodocumenteveryaspectoftheprocess,
activities,andoperationsinvolvedwithdrugandmedicaldevicemanufacture.Ifthedocumentationshowinghowthe
productwasmadeandtested(whichenablestraceabilityand,intheeventoffutureproblems,recallfromthemarket)
isnotcorrectandinorder,thentheproductdoesnotmeettherequiredspecificationandcouldbeconsideredtobe
adulterated.

TypesofDocuments
Thedifferenttypesofdocumentsfoundwithinpharmaceuticalandmedicaldevicefacilitiesweredescribedearlier.
Themaintypesofdocumentsarenowdiscussedinmoredetailwithdifferencesbetweenthedifferenttypesnoted.

Specifications
Specificationsaredocumentsrelatedtostartingmaterials,packagingcomponents,andfinishedproducts.They
describethestandardstowhichthesematerialsandproductsmustcomplyiftheyaretobeapprovedforusein
manufacturingorforcommercialsale.Forexample,thefinishedproductspecificationshouldcontain:
Thedesignatednameoftheproductandthecodereferencewhereapplicable
Theformulaorsuitableareference
Adescriptionofthepharmaceuticalformandpackagedetails
Directionsforsamplingandtestingorareferencetoprocedures
Thequalitativeandquantitativerequirementswiththeacceptancelimits.Forexample,thesterilitytestor
absenceofspecifiedpathogens
Thestorageconditionsandanyspecialhandlingprecautions,whereapplicable
Shelflife.

Instructions
Allinstructionstopersonnel(forexample,mediamanufacture,bacterialidentification,analyticalmethods,andsoon)
shouldbeclear,precise,unambiguous,andwritteninnumberedsteps.Theyshouldbewritteninalanguageandstyle
thattheusercanreadilyunderstand.Associatedwithinstructionsarerecords.Thesecanbeeithercombinedwiththe
instructionorinaseparatedocument.

BatchDocumentation
Amajorelementinfinalproductreleaseshouldbeareviewofalltherelevantbatchdocumentationtoensurethe
presenceofallnecessaryinformationandthesatisfactorycompletionofallnecessaryrecords.Thiswillinclude
sterilizercharts,microbiologicaltestingcertificatesofanalysis,processrecords,testresults,andsoon.

ProceduresandRecords

http://www.ivtnetwork.com/article/gooddocumentationpractices

4/7

21/10/2016

GoodDocumentationPractices|IVTJVT
Inadditiontotheinstructionandassociatedrecordsdescribedabove,specificproceduresincludingmaterialreceipt,
sampling,testingrejection,complaints,andotherdocumentsarealsorequired.
DependingofthetypeofdocumentGMPexpectationsarethatthedocumentcarries:
Productname
Descriptionoftheitem
Referencenumberanditemcode
Packorbatchsize
Listofmaterials
Specificprecautionsorinstructions
Namesofassociatedpersonnel
Datesandtimes
Versionnumber
Approvals.

BestPracticesforDocumentCreationandUse
Acompanyshouldcontinuallyevolvegoodpracticesforcreationofdocuments.Itisimportantthatdocumentsare
designed,prepared,reviewed,anddistributedwithcare.Documentsalsomustbeapproved,signed,anddatedbythe
appropriatecompetentandauthorizedpersons.Further,documentsmustberegularlyreviewedandkeptuptodate.
Whenadocumenthasbeenrevised,systemsmustbeoperatedtopreventinadvertentuseofsupersededdocuments.It
isespeciallyimportantthatonlycurrentdocumentationshouldbeavailableforuse[7].Afurtherimportant
considerationistoensurethattherecordscanbekeptinanorderlyfashiontofacilitateretrievalatsomeunspecified
timeinthefuture.
Bestpracticesextendtothewritingofthedocument.Usingwordsthateveryonecanunderstandminimizingjargon,
acronyms,andabbreviationsandusingwordswithunambiguousmeaningcanhelpthereadertomoreeasily
understandandinterpretthedocument.Key"readability"qualitiesforadocumentinclude[8]:
Concise:Presentinformationclearlysoitcanbeeasilyunderstoodwithnoroomformisinterpretation.For
example,thedateformat"06/05/14"cancauseconfusion.Itisbettertouseonethatisunambiguous,suchas
"05jun2014,"especiallyifthedocumentisusedintheUSandEurope.
Legible:Informationshouldbereadableandleavenoroomforerror.Forexample,handwrittendatathatare
notlegiblemaycreateerrorsindataanalysisorresultinmissingdata.
Accurate:Documentationshouldbeerrorfreeproperlyreviewed,verifiedandapproved.Informationshould
berecordedasaneventhappensandnotafterthefacttoavoidrecording"whatyouremember"ratherthan
"whatactuallyhappened."
Traceable:Documentationshouldbetraceable.Itshouldbemadeclearwhologgedtheinformation,whatit
was,andwhenandwhyitwasdocumented.
Tohelpwithefficientlocationofrecords,attentionshouldbepaidtonumberingincludingtheversionnumberfor
traceability.Simplesequentialnumberofdocumentsonlyworksforasmallnumberofdocuments.Inmostcasesa
definedstructuretothenumberingsystemisneeded.Forexample,001100couldrepresentregulatorydocuments,
101200couldrepresentQCtestingdocuments,and201300couldrepresentproductiondocumentation.This
systemmaystilllimiting.Thenumberingsystemmayneedtoincludereferencestothesite,asystem(production,QC,
validation,andsoon)aswellasitssequentialnumber.

DocumentStyleandLayout
Itisoftenhelpfultoadoptaspecificdocumentstyleforconsistencyofoperations.Elementsofthestyleshouldbe
specifiedinanapprovedprocedure.Thesemightinclude[9]
Logo
Pagination/layouttopreventconfusionandensurethedocumentiskeptinorder
Headersandfooters
Fontincludingthesizeisusefultominimizeerrorsintroducedwhenchangingbetweenfonts
Pagenumbers
Executivesummary
ChangesChangecontrolisimportantfortraceability
Circulationlisttoensurethedocumentisreviewedandreceivedbytheappropriatepersonnel
Tableofcontents
Authorizationlevelsstatedondocument
Crossreferences
Revisionhistory
Definitions
Content(contextandmeaning)
Aclearareaforrecordingproblems/incidents
Useofpictures,flowcharts,diagramsassuitablealternativestotext.
Careshouldbetakenindesigningandstylizingdocumentation.Documentsmusthaveunambiguouscontents.The
title,nature,andpurposeshouldbeclearlystated.Theymustbelaidoutinanorderlyfashion.Documentsmustbe
easytocheck.Reproduceddocumentsmustbeclearandlegible.Manypeopledonotconsidertheimportanceofhow
keyinformationispresentedwithinadocument.Thiscanresultinthereaderwastingtimeornotconductingthe
correcttasks.Forexample,apoorlystructureddocumentcouldasktheusertoconductataskthatrequiressomeaction
tobeperformedpriortothesubjecttaskbutonlymentionsthepreworkattheendofthedocumentandwithno
referencetothepreworkatthebeginning.
Helpfulconsiderationsforlayoutsincludethefollowing:
Coverpagewithidentifiersandstatus
Tableofcontentscreatingaroadmapthroughthedocument
Scopeandapplicabilitysection
Introduction

http://www.ivtnetwork.com/article/gooddocumentationpractices

5/7

21/10/2016

GoodDocumentationPractices|IVTJVT
Informationandinstructionsinalogicalsequence
Additionalinformationanddetail.
Numericalinformationmustincludethecorrectuseofunits.Theuseofcolorcodingingraphicalinformation,suchas
blacklinesforexistingpipeworkandredlinesfornewpipework,mightalsobeuseful.
Thenarrativemustconsiderwritingstyle,nomenclature,anddealingwitherrorsandcorrections.Whenconsidering
thenumericalissues,whatareviewedasstandardunits?Thinkaboutmathematicalsymbolsandtheorderinwhich
calculationsareperformed.Forexample,thebodmasapproach(b)rackets(o)rder(d)divide(m)ultiply(a)ddition
(s)ubtraction,isuseful.Ifsomeonegetsthesequencewrong,theywillgetthewrongresult.Itisalsoimportanttothink
abouttherulesonrounding,i.e.,Above0.5,roundup,etc.Finally,considerstandardizingsymbolsindrawings.
Itisusefultoconsiderdifferentstylestoaccommodatethedifferentreadingstylesofreaders.Therearethoughttobe
threestylesbasedonthelinguistic,logicalandspatialtalents.Thesecanbesummarizedas[10]:
Linguistictalent.Thereisastrongabilitytowriteandtalkfluently.Phraseslike"giftofthegab"oftenapply.
Individualsinthiscategorycanalsowriteandreadwell.Shakespearehadlinguistictalent.
Logicaltalent.Thereisstrongabilitytothinklogicallyandarequickincalculatingoddsandstatistics.Albert
Einsteinhadlogictalent.
Spatialtalent.Thereisstrongabilitytoimagethingsinthe"mind'seye."Thesepeopleoftenhavegood
navigationalskillssuchasChristopherColumbus.
Thefollowingshouldbeconsideredwheneverpossible:
Narrativewrittentext
Tabulartables
Chartsbarcharts,piecharts
Colorboldunderlinedtext
Picturesphotographs,images
Diagrams2d,3d
Processlogicflowcharts
Includingvariouscombinationsoftheaboveisextremelyuseful.Aflowchartmighthelpwithnavigatingthedocument
whilepicturesareveryusefulindressingproceduresforentryintocleanrooms.Tablesareusefulforsummarizingdata
suchasmicrobiallimitsforenvironmentalmonitoring.
Theuseofcrossreferencingindocumentsishelpfulinkeepingthedocumentshortandmanageable.Becarefulofcross
referencingtoomanydocumentsasthiscanbeselfdefeating.Theuserwillnotfollowtheprocedureiftheyhaveto
locatetoomanyotherdocuments.
Finally,considerationoftheenduserwhenwritingisalsoextremelyimportant.Toooftendocumentsarewrittenby
managersortechnicalstaffwithoutthoughtforthepeoplethatwillbeusingthem.Ideallyitisrecommendedthatthe
enduserwritesthedocument.

CompletingDocumentsandRecordKeeping
Afterdocumentshavebeendesigned,prepared,andapproved,theymustbeusedandcompletedproperly.For
example,wheredocumentsrequiretheentryofdata,theseentriesmustbemadeinclearlegiblehandwritingusinga
suitableindeliblemediumnotapencil.Sufficientspacemustbeprovidedforentries.Withsuchentries,itis
importantthatanycorrectionmadetoadocumentorrecordmustbesignedorinitialedanddatedthecorrectionmust
permitthereadingoftheoriginalinformation.Whereappropriate,thereasonforthecorrectionmustberecorded.
Withrecordkeepingingeneral,arecordmustbekeptatthetimeeachactionistaken.Allactivitiesconcerningthe
conductofpreclinicalstudies,clinicaltrials,andthemanufactureandcontrolofproductsmustbetraceable.

ElectronicRecords
Theadventofcomputerizedsystemscausedindustrytomoveawayfrompaperbasedsystemstopaperlesssystems.
Electronicrecordsoffermanyadvantages.Therealityisthattypicallythereisabalancebetweenthetwo.Forexample,
considerarecordfortheabsenceofpathogentestonanonsterileproduct.Recordingthetestresultpresentsuswith
twooptions.Firstlyitcanandofteniswrittenonalogsheet.Secondlywecanusealaboratoryinformation
managementsystem(LIMS)torecordtheresultelectronically[11].
AsacontrolledformitwillbecreatedinMicrosoftWord(electronic)andprintedontopapertocheckitsoitcanbe
signedforapprovalgivingitstatus.Thiscanbedoneonscreenbutmanypeopleprefertoreviewahardcopy.Approval
canbeelectronicrecordingusernameandpassword,ortheprinteddocumentcanbephysicallysigned.Inthelatter
case,theapproveddocumentcouldbescannedsoitcanbestored,distributed,andreferencedelectronically.A
physicallyapproveddocumentwillneedphotocopyingifitistobedistributedinthe"paperworld."Electronic
distributionofaphysicallysigneddocumentcansaveonpaperbutdoespresentproblemsmainlyfromthescanning
process.Ascanthatcreatesapictureoftheoriginalwillbeaverylargefile.Useofopticalcharacterrecognitioninthe
scanningprocessproducessmallfiles,butthescanningprocessintroduceserrorswherecharactersmaygetmissedor
replacedrequiringafurtherproofreadoftenfromapaperprintout.Duringtheactivestage,personnelmayprefera
hardcopytoworkfromsothatanelectronicdocumentwillbeprintedontopaper.
Archivingofpaperrecordsiscostlyintermsofspaceandtosomedegreeretrievability,butlittlemoreintermsof
maintenance.Archivingofelectronicrecordspresentsmorechallengingproblems.Theyonlyexistasaseriesof"1's"
and"0's"(binarycode)onstoragemedialikeaCDROM.Withelectronicrecordarchiving,thetechnologywindow
mustbeunderstood.ThismeansthatthedatamightbeavailableontheCD,butafter5yearstheremaynotbeany
hardwarethatcanreadit.Essentialtoelectronicrecordarchivingisthatcompanieshaveanadequatemigration
strategy.Paperrecordsarestillusableafterseveralthousandyearsbutdataondiscsmaybelostafteronly510years,
orashorterperiodifthediscsarenotproperlycontrolled.Themigrationstrategyshouldalsoincludetheregular
transferofdataontofreshmedia,evenifthehardwarehasnotchanged.
TherequirementsforelectronicrecordsandsignaturesaredealtwithintheUStitle21part11oftheCodeofFederal
Regulations(CFR).Althoughorganizationsdonothavetouseelectronicrecordsandsignatures,iftheydo,theymust

http://www.ivtnetwork.com/article/gooddocumentationpractices

6/7

21/10/2016

GoodDocumentationPractices|IVTJVT
complywiththeCFR.Itisimportantthatsuchrecordsareaffordedtheequivalencetopaperrecordsandhandwritten
signatures.TheCFRmakeitclearthatproceduresshallbefollowed,recordsshouldbedocumentedatthetimeof
performance,anddeviationsrecordedandjustified.

DocumentStorage
Storageofcriticalrecordsmustatsecureplace,withaccesslimitedtoauthorizedpersons.Inrelationtothis,21CFR
211.180(d)states"theserecordsorcopiesshallbesubjecttophotocopyingorothermeansofreproductionaspartof
suchinspection.Recordsthatcanbeimmediatelyretrievedfromanotherlocationbycomputerorotherelectronic
meansshallbeconsideredasmeetingtherequirementsofthisparagraph."
Thestoragelocationmustensureadequateprotectionfromloss,destruction,orfalsification,andfromdamagedueto
fire,water,andotherdisasters.Recordswhicharecriticaltoregulatorycomplianceortosupportessentialbusiness
activitiesmustbeduplicatedonpaper,microfilm,orelectronically,andstoredinaseparate,securelocationina
separatebuildingfromtheoriginals.
Datamayberecordedbyelectromagneticorphotographicmeans,butdetailedproceduresrelatingtowhateversystem
isadoptedmustbeavailable.Accuracyoftherecordshouldbecheckedasperthedefinedprocedure.Ifdocumentation
ishandledbyelectronicdataprocessingmethods,onlyauthorizedpersonsshouldbeabletoenterormodifydatainthe
computer,accessmustberestrictedbypasswordsorothermeans,andentryofcriticaldatamustbeindependently
verified.
Ifelectronic,photographicorotherdataprocessingsystemsareusedfortheretentionofdocuments,anappropriate
storageforrequireddurationisnecessarytoprotectagainstlossordamage.Itisparticularlyimportantthatduringthe
periodofretention,thedatacanberenderedretrievableandlegiblewithinanappropriateperiodoftime.Thismeans
havingavalidatedsystemofdatarecall.Thedatashouldalsobeavailableinalegibleform.Rapidretrievalofreports
anddataisessentialforaudits.

Summary
Thispaperhaspresentedanoverviewofthemaintypesofdocumentationfoundwithinthepharmaceuticaland
medicaldevicesectors.Ithasprovidedsuggestionsforgoodpracticeexamplesofhowthedocumentationcanbe
designed,produced,andcontrolledaspartofacompliantGMPsystem.Gooddocumentationpracticesareanessential
partofGMPandcompliance.Whenimplemented,therecommendationspresentedinthispaperwillhelpwith
maintainingcontrolandensuringcomplianceinaGMPenvironment.

References
1.Hargreaves,P.(2007)."GoodManufacturingPracticeintheControlofContamination"inDeyner,S.P.and
Baird,R.M.(eds.),GuidetoMicrobiologicalControlinPharmaceuticalsandMedicalDevices,2ndedition,CRC
Press,BocaRaton,FL,pp121142.
2.Patel,K.T.andChotai,N.P.,(2008).PharmaceuticalGMP:Past,Present,andFutureaReview.
Pharmazie.63(4):2515.
3.Todd,J.I.(2007).GoodManufacturingPracticeforImmunologicalVeterinaryMedicinalProducts.RevSci
Tech.26(1):13545.
4.Gbel,C.,Baier,D.,Ruhfus,B.andHundt,F.(2009).GCPInspectionsinGermanyandEuropeFollowingthe
ImplementationoftheDirective2001/20/ec,GerMedSci.317:doc01.Doi:10.3205/000060.
5.Sandle,T.andLamba,S.S.(2012)."EffectivelyIncorporatingQualityRiskManagementintoQualitySystems".
inSaghee,M.R..(ed.).AchievingQualityandComplianceExcellenceinPharmaceuticals:AMasterClassGMP
Guide,NewDelhi:BusinessHorizons,pp89128.
6.Bolton,F.J.andHowe,S.A.(1999)."DocumentationintheLaboratory"inSnell,J.J.S.,Brown,D.F.J.,and
Roberts,C.QualityAssurance:PrinciplesandPracticeintheMicrobiologyLaboratory,pp1928.
7.Patel,k.T.andChotai,N.P.(2011).DocumentationandRecords:HarmonizedGMPRequirements,JYoung
Pharm.3(2):138150.
8.Sachdeva,V.(2012.).GoodDocumentationandQualityManagementPrinciples.Retrievedfrom:
http://apps.who.int/prequal/trainingresources/pq_pres/stakeholders_2011/...
9.Sandle,T.(2009)."BestPracticesforMicrobiologicalDocumentation"inHodges,NandHanlon,G.(eds.):
IndustrialPharmaceuticalMicrobiologyStandardsandControls,EuromedCommunications,England,
Supplement9,s9.1s9.24.
10.Gardner,H.(2000).IntelligenceReframed:MultipleIntelligencesforthe21stCentury.BasicBooksInc.,USA,
pp2746.
11.Sandle,T.andAlexander,B.(2011).ElectronicPack1:BestPracticesinMicrobiologicalDocumentation,
PharmaceuticalMicrobiologyInterestGroup,Pharmig:StansteadAbbotts,UK.
DownloadtheentirearticleinPDFformat

PRINTERFRIENDLYVERSION

Tags:JVT

http://www.ivtnetwork.com/article/gooddocumentationpractices

7/7