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Level 3 Level 3
Volume 15 Issue 2 Article 10
2020
The Challenges of Remote Auditing Faced by the Pharmaceutical The Challenges of Remote Auditing Faced by the Pharmaceutical
Industry Industry
Megan Hannon Technological University Dublin, anne.greene@tudublin.ie
Follow this and additional works at: https://arrow.tudublin.ie/level3
Recommended Citation Recommended Citation Hannon, Megan (2020) "The Challenges of Remote Auditing Faced by the Pharmaceutical Industry," Level 3: Vol. 15: Iss. 2, Article 10. doi:https://doi.org/10.21427/yj8x-cm05 Available at: https://arrow.tudublin.ie/level3/vol15/iss2/10
This PART 2: Research articles from MSc cohorts on the Pharmaceutical Validation Technology (PVT) and Pharmaceutical Quality Assurance (PQA)programmes, PRST, TU Dublin is brought to you for free and open access by the Current Publications at ARROW@TU Dublin. It has been accepted for inclusion in Level 3 by an authorized administrator of ARROW@TU Dublin. For more information, please contact arrow.admin@tudublin.ie, aisling.coyne@tudublin.ie.
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AuthorMeganHannon,TechnologicalUniversity(atDublin
Abstract
Onthe11thofMarch2020,theWorldHealthOrganisation(WHO)declaredtheCOVID-19outbreak as a global pandemic. The way companies operated had to change and manypeoplearenowencouraged towork fromhome. Companieshavehad toadaptmanyoftheir work practices and in some cases adopt new ways conducting activities suchconducting and hosting of audits. The paper seeks to investigate the challenges andpotentialbenefitswithconductingremoteaudits.
Anindustry-basedsurveywasconductedtoidentifythechallengeswithconductingremoteauditsfromthepharmaceuticalindustry’sperspective.Toovercomesomeofthechallengesidentifiedanactionplanisproposedtofacilitatecompaniesinpreparingforremoteaudits,asitappearsthis“newnormal”maybesomethingthatweallhavetoadapttointhefuture.
IntroductionOnthe11thofMarch2020,theWorldHealthOrganisation(WHO)declaredtheCOVID-19
outbreak as a global pandemic(WHO, 2020). COVID-19 is a highly contagious virus that
attacks the lungs and airways. There is currently (at the time of writing this paper,
November 2020) no vaccine approved for COVID-19. Due to the fast spread of the virus
throughout the world, governments are developing and enforcing plans to control the
spreadoftheviruswithintheircountries.ThefirstcaseofthevirusinIrelandwasconfirmed
on the28thofFebruary. International travelbans formanycountrieswereenforced inan
efforttocontrolthespreadofthevirus.Thistravelbanhasimpactedmanyindustrysectors,
includingthepharmaceuticalindustry.Oneimpactofthistravelbanwasthepostponement
of on-site ‘GoodManufacturingPractice’ (GMP) audits.Auditorswouldnormally travel to
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manufacturing sites to inspect facilities; this is no longer possible with such travel bans.
Companieshavehadtocomeupwithnewapproachesandwaysofconductingsuchaudits.
Equally,regulatoryagentshavehadtodevelopplansonhowtoconductGMPcompliance
auditsutilisingstaffina‘remoteworking’environment.
TheEuropeanMedicinesAgency(EMA,2020)hasreleasedupdatedguidanceonauditsand
has deemed remote auditing acceptable.While travel bans are being rescinded by some
countries, rulesandgoodhygieneetiquette regarding socialdistancingwill still apply into
the future. Social distancing is definedmaintaining safe space (typically about 2metres)
fromsomeonenotfromthesamehousehold(CentersforDiseaseControlandPrevention,
2020). This is been termed the new ‘normal’; furthermore, it is anticipated that social
distancing will be in place until a successful vaccine is found. This ‘social distancing’
etiquettewillhaveamajor impactonGMPauditingon-site,evenwhenalltravelbansare
lifted.Thishasresultedincompanieswithintheindustry,conductriskmanagementplans
foralloftheiroperationsincludingauditingactivities.
With such restrictions and operational requirements now in place, companies and
regulatorsarenowexploringtheconceptofremoteGMPauditingtoreplacethetraditional
on-siteaudit.Onepossiblesolutionisremoteauditsperformedoff-sitethroughtheuseof
information and communication technology (FDA, 2020). When the European Medicines
Agency (EMA) issuedguidance toassist the industryduring theCOVID-19Pandemic; they
extended thevalidityperiodof currentGMPCertsandstated that ‘Ifneeded, inspections
willbecarriedoutremotelytosupportsuchextensions,withon-siteinspectionscarriedout
assoonasfeasible’(EMA,2020).
RemoteAuditingRemote/digital auditing is a form of accessing a company for compliance by
teleconferencing, phone calls and emails. Traditionally in the pharmaceutical industry
regulatory and supplier audits are held on site. The COVID-19 pandemic has forced both
companies and regulatory agents to think about the auditing process in a different way.
Withtheadvancesintechnologyitisnowpossibleforauditstobeheldremotely.
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Remote auditing is one of the audit methods described in International Standards
Organisation(ISO)guidancedocumentISO19011:2018AnnexA1(ISO,2018).However,this
waspublishedbeforetheoutbreakofCOVID-19.AnupdatedISOguidancedocument“ISO
9001AuditingPracticesGroupGuidanceon:REMOTEAUDITS”(ISO,2020)wasissuedinApril
2020andgivesextraguidanceonremoteauditingasaresultoftheglobalpandemic.The
guidancedocumentoutlinesdifferent areas that need tobe consideredwhen conducting
remoteaudits.Italsodetailssomepotentialrisksandlimitationswithremoteauditing.
‘The first step to ensure feasibility is determining what technology may be used, if
auditorsandauditeeshavecompetenciesandthatresourcesareavailable’
(ISO,2020)
Without the correct technology remote auditing is not possible. One pressing area of
concernthatmustbeaddressedbeforeremoteauditsaredecided is thatofdatasecurity
and protection. In terms of data security and protection there should be appropriate
agreements put in place between the auditee and the auditor. Before COVID-19 it is
possible that the use of screensharing and video recording many not been covered in
agreementsand thisneeds tobe rectified inany futurearrangements.The ISOdocument
states‘whenanalysingfeasibility,thedigitalqualityofthedatatobereviewedshouldalso
beconsidered’(ISO,2020).Thisisanimportantfactortobeconsideredasremoteauditing
maynotbefeasibleifacompany’sdocumentationisnotcompletelydigitised.
RegulatoryAuditsTheEMAcoordinatestheinspectionsformedicalproductsthataremanufacturedandsold
within the EuropeanUnion (EU). The EMAdoes not conduct audits itself, the competent
authorities of EU member states must conduct these audits, in accordance with EMA
guidance and regulations. The Health Products Regulatory Authority (HPRA) conducts
Regulatory GMP audits on behalf of the EMA in Ireland. Typically, these audits are done
every2to3years,usingarisk-basedapproach.
TheEMAhavestatedthatcurrentGMPcertificateswillbeextendeduntiltheendof2021
forcompaniesintheEuropeanEconomicArea(EEA).However,itshouldbenoted;thisdoes
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notcoveranychangestotheGMPCertificate.IfacompanyislocatedwithintheEEAbutthe
facility has never been inspected before, therewill be a need for a ‘distant assessment’.
This is identified as a remote audit, with the provision that ‘on-site inspection should be
conducted when circumstances permit’ (Medicines Agency, 2020). The EMA have stated
thattheywillconduct‘distantinspection’ifrequiredsocompaniesneedtopreparetohost
theseinspectionsifrequired.
SupplierManagementEveninthemiddleofaglobalpandemicthesafetyofdrugsdeliveredtopatientsisapriority
fortheregulatoryagents.Thismeanscompaniesmuststillensurethecompetencyoftheir
supplierandcontactmanufacturers. Itwasmadeclear in theEMAQ&Adocument issued
April2020that‘thattheobligationofmanufacturersandimporterstocomplywithGMPis
notwaived’(MedicinesAgency,2020)’.Companieshavehadtoadoptnewwaysofworking
andstillensuretheyhaveoversiteoftheirsuppliersandcontractmanufacturers.TheEMA
also identify and explain some regulatory flexibility during the COVID-19 pandemic in
relation to this aspect of suppliermanagement. Temporary changes arepermittedwhen
requirede.g.‘Onsitesre-auditsofsuppliers,andreplacementbyremoteaudits’(Medicines
Agency,2020).
An assessment using an appropriate risk-based approach and the use of a Quality Risk
Management system is recommended. ‘Remoteaudits shouldprovide confidence that the
contractedparty is fit-for-purposeandwillnotnegativelyaffect thewholesaledistribution
process’ (Medicines Agency, 2020). This requires companies to develop remote auditing
plans using a robustmethodology and framework. To explain, each situation should be
assessed,documented,andauthorisedusingarisk-basedapproach.
InJanuary2009ICHguidelineQ9onQualityRiskManagementwasreleased.Thisguidance
documentenablesmanufacturerstobuildinqualityriskmanagementtotheirprocessfrom
developmenttopackingandshippingwithinthestagesofproductlifecycle.Themainfocus
ofriskmanagement is toproduceasafeandeffectivedrugforpatients.ThetermQuality
RiskManagementisdefinedbytheICHas‘Asystematicprocessfortheassessment,control,
communication,andreviewofriskstothequalityofthedrug(medicinal)productacrossthe
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product lifecycle’. The term ‘risk’ is described as ‘The combination of the probability of
occurrenceofharmandtheseverityofthatharm(ISO/IECGuide51)’.Riskassessmentsare
usedtodeterminetherisksandhowtoeliminateormitigateagainstthem.
ICHQ9 identifies that quality risk management can be integrated into auditing and
inspections planning ‘To define the frequency and scope of audits, both internal and
external’Riskassessmentsconsiderdifferentfactorswhendeterminingtheauditschedule
suchas:perviousinspectionreports;and,thecomplexityoftheproduct.Riskmanagement
isusedbymanufacturersandtheregulatoryagentstoplantheirinspections‘Toassistwith
resource allocation. including, for example, inspection planning and frequency, and
inspection and assessment intensity’ (ICH, 2015). Bothmanufacturers and regulators are
advised to use riskmanagement tools to assess the risk in conducting audits during the
globalpandemic.Thegoalisalwaystoreducetherisktopatientsbutalsoduringaglobal
pandemic, theeliminationormitigationof this risk for inspectors tovisitamanufacturing
facility needs to be considered.Whilemindful of the recommendation that non-essential
travelshouldbeavoided;iftheriskassessmentscanjustifyeitherextendingtheperioduntil
theauditorperformingremoteaudits,thisrecommendationshouldbeobserved.
RemoteWorkingTheCOVID-19globalpandemichasimpactedtheworkinglivesofpeopleinmanydifferent
ways. Some of these impacts include people encouraged towork from home, the Irish
government as part of the ‘Plan for Livingwith COVID-19’ has stated remoteworking is
encouraged where possible across all levels of the plan (Ireland, 2020) . Equally, many
childcare facilities were forced to close or suspend services which in turn added greater
pressures on parents. The workplace and the childcare facility were now the home for
manypeople.Moreover,whiledifficulttohavepredictedaglobalpandemic;manypeople
werenotreadyforthischangeintheirdailylivesofworkandchildcare.Thesechangesin
lifestyleconditionshaveaffectedpersonnelintermsofpersonalstressintheirlives.
Studieslookingintothepsychologicaleffectsofremoteworkinghavefoundthatitcanlead
personneltofeeloverwhelmed,uncertaintyandsocialisolation(Allen,2020).Itissuggested
that thosewho primarilywork fromhome face isolation and are less able to collaborate
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effectively with colleagues (Allen, 2020). To overcome feelings of isolation people are
comingupwithnewideassuchasavirtualcoffeedate;assigning30minswithcolleaguesto
talk about issues other than work. Furthermore, it is found that often training for
teleworking/remoteworkingislacking,resultinginstaffstrugglingtodevelopacompetent
levelofefficiency(Grant,WallaceandSpurgeon,2013).Theglobalpandemic’sswiftspread
across the globe further tested organisations’ capabilities to deliver remote working
training. The main issue with remote working for staff members is finding the balance
betweenworkandhome life. More importantly,with technology there isa linkbetween
workandthehomeenvironment;boundariesareoftenblurredmakingithardforworkers
toswitchoff(Grant,WallaceandSpurgeon,2013).
There are also the technical difficulties with working remotely. Personnel need to have
accesstobroadbandwhileathometobeabletoconducttheirroleseffectively.Companies
alsoneed to ensure that their staff have the correct technology at home such as screen,
keyboards etc. Companies should also put in place procedures for security and
confidentially agreements while working remotely, these procedures and policies should
detailthecorrectprocessforworkingfromhometoensuretheconfidentialityofwork.The
procedures should include detail on topics such as paperwork being removed from the
manufacturingsiteandbroughttoapossiblylesssecurehome.Riskassessmentsshouldbe
conductedtoensurerisksofworkingremotelyarecapturedandmitigated.
Non-Verbal Communication Non-verbal communication involves the unspoken word, interactions between people
through body language, facial expressions, hand movements and eye contact. This non-
verbalcommunicationislostduringremoteaudits.Theexistenceofavisualchannelwhile
talkingfacetofaceincreasesthesocialpresencebyallowingforvisualcluesthatcanalter
themeaningoftheaudiochannelalone,often inunconsciousways(Short,J.,1976).Non-
verbalcommunicationhasaninfluenceoverthewholecommunicationprocess.
‘Peopleassumethatnon-verbalactionsdonotlieandthereforetheytendtobelieve
thenon-verbalmessagewhenaverbalmessagecontradictsit’(Bessonetal.,2005).
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Non-Verbalcommunicationcangiveawaydetailsthatmaynotbeexpressedduringverbal
communication. Body language is important during audits as it can relay or convey a
messagee.g.ifsomeone’slegisshakingitmaymeantheyarenervous.Orwhenanauditee
is moving their hand when explaining a process, it may mean they are passionate and
confident. Eye contact is another form of non-verbal communication and it is also
particularly important during audits. The frequency of eye contact may suggest either
interestorboredomormayevenbetraydishonesty(Bessonetal.,2005).Facetofaceaudits
by their very nature can reveal more non-verbal forms of communication to both the
auditor and the auditee. However, not all non-verbal communication is lost during
telecommunication.
Thetoneofanindividual’svoiceisconsideredanon-verbalcommunication.Toneofvoice
can communicate if a person is aggressive, critical, nervous, disappointed, monotonous,
friendly,enthusiastic,vivid,andpersuasive;thesedifferenttonescanbecuestotheauditor
aboutasituationinquestion.
Methodology – Industry Survey Asurveywascreatedtoprovidebothqualitativeandquantitativedataonperspectivesheld
on this research topic within the pharmaceutical and biopharmaceutical industry. This
surveywascreatedusing‘SurveyMonkey’;itconsistedof10questionsthatweredesigned
toobtaintheappropriatequalitativeandquantitativedataneeded.Conductingthissurvey
allowedtheauthortodiscoverandidentifycurrentopinionheldonremoteauditing.Data
gatheredalloweda“snapshot”ofopinionintheearlystagesofthe“workingfromhome”
situation we have found ourselves in and to draw some preliminary conclusions on the
impactsthisishavingonthepharmaceuticalindustry.
The survey was completed by seventy-six (76) personnel who work within the Irish
pharmaceuticalandbiopharmaceuticalindustries.ThesurveywassharedonLinkedIn,alsoa
numberofpersonnelwhohaveexperienceintheareaof‘RemoteAuditing;werecontacted
directlytocompletethesurvey.Oneaimofthesurveywastoidentifytheirperspectiveon
currentchallengestheyarefacingwithremoteauditing.
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Results1. Whatindustryareyouworkingin?
FromtheresponsesreceivedmajorityofpeoplewhorespondedworkedintheBio-
pharmaceutical industry (46%) or the pharmaceutical industry (37%) the other
respondentswhereinthemedicaldeviceindustryorother.
Figure3:INDUSTRYSECTOR
2. Whatdepartmentareyouworkingin?
Ofthe76respondents67workedintheQualityDepartmentintheircompany.Theother9
respondentsworkedbetweenQC,ManufacturingandValidation.
3. Hasyourcompanyconducted/hostedanyremoteaudits?
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This was asked in order to determine the number of remote audits that have been
conducted.Fromtheresponses,67%ofcompanieshaveconductedremoteaudits.22%of
respondents answeredNOwhile 10%DIDNOTKNOW if their companyhad conductedor
hostedanyremoteaudits.
Figure4:FREQUENCYOFREMOTEAUDITS
4. Have your company’s auditing procedures been updated to manage remote
auditing?
Question4wasaskedinordertodetermineiftheindustryhadconsideredremoteauditing
before the COVID-19 pandemic. 25% ALREADY HAD INFORMATION on remote auditing.
While 37% said YES, their procedures needed to be updated and 37% said NO their
procedureshavenotbeenupdated.
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Figure5:UPDATEOFAUDITINGPROCEDURES
5. Rank these remote auditing challenges in order ofwhat you think are themostchallenging1beingthemostchallenging5beingtheleastchallenging
Thisquestionwasaskedinordertodeterminetheindustry’sopiniononthechallenges
withremoteauditing.Thefollowingchallengeswererankedfrom1-5.
a. ConductingVirtualToursb. SharingofDocumentationc. DataSecurityConcernsd. InsufficientITPlatformse. ConductingPersonnelInterviews
All of the challengesprovidedwere identifiedwithbyall respondents. Conductingof
virtual tourswas ranked themost challengingby 29 respondents,whileData Security
Concernswasidentifiedby22respondentsasbeingmostchallenging.Furthermore,the
least challenging aspect was identified by 35 respondents as Conducting Personnel
Interviews.Overall,thepriorityofchallengesbytheirScoreMarkingwasidentifiedas:
1. ConductingVirtualTours. 3.67.
2. DataSecurityConcerns. 3.49.
3. SharingofDocumentation. 2.86.
4. InsufficientITPlatforms. 2.81.
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5. ConductingPersonnelInterviews. 2.16.
*Thescoremarkingiscalculatedbycalculatingtheaveragerankingforeachanswerchoice
Figure6:RATINGOFREMOTEAUDITINGCHALLENGES
6. Doyouthinkthereareanybenefitsofremoteauditing?
Thisquestionwasaskedtoidentifytheindustry’sattitudetowardsremoteauditing
and if it could returnbenefits. Respondentswere asked to choose ‘Yes’ or ‘No’; if
theychose‘Yes’theywereaskedtoidentifytheperceivedbenefits.
61 respondents answered YES to this question. Of the 61 that responded YES, 55
commentedtowhattheythoughtwerethebenefitstoremoteauditing.Ofthese55
comments, 21 respondents stated that ‘Reduced Travel’ as a benefit. There were
also respondents believing the benefit of easier pre-planning for remote audits
exists.Anotherrespondentstatedthatabenefitwas:thatit‘Allowsamorefocused
review and make optimal use of auditors time thereby potentially increasing the
samplesizeforaudits.
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Figure7:BENEFITSTOREMOTEAUDITING
7. Isallyourcompany’sdocumentationavailableelectronically?
This questionwas asked to determine howmuch of the industrywas paperless. Remote
audits can by their nature involve no paper and relies on the review of electronic
documents,so ifcompaniesdonothavetheseavailable itwillbehardertoplanforthese
audit types.Of the75respondentsonly3%havenodocumentsavailableelectronically.A
majorityofrespondents,54%identifiedtheircompanyashavingahybridofbothpaperand
electroniccopies;43%ofrespondsidentifiedalldocumentsareavailableelectronically.
Figure8:AVAILABILITYOFELECTRONICDOCUMENTS
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8. Doyouthinktherearecomplianceriskstoremoteauditing?
This question was asked to gain the industry’s opinion on compliance risks. 53% of
respondentsbelievedtherearecompliancerisksassociatedwithremoteauditing.With46%
believing there are no compliance risks. Respondents that answered yes, were asked to
identifythesecompliancerisks.
Figure9:COMPLIANCERISKSWITHREMOTEAUDITING
Manyoftherespondentsbelieveitisdifficulttogainanoverallimpressionofacompanyvia
remoteauditing.Whileclearthatreviewofdocumentationiseasierremotely,otheraspects
ofauditingarenotandthereforeconsideredariskforthefollowingreasons.
‘Auditsampleismorecontrolledbyauditee’
‘Itiseasiertohideissuesinaremoteaudit’
‘Youonlyseewhatyouareshownwithremoteauditing’ ‘Somethingscouldbehiddenfromcamerathatcompanydoesn’twanttobeseenbyauditor’
‘Virtual tours reliant on the auditee to provide a true representation of theareaunderreview’.
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9. DoyouthinkyourcompanyhastheITcapabilitiestoconduct/hostremoteaudits?
Themain factor to a remote audit is the IT capabilities without such technology remote
audits are not possible. When identifying how many of the respondents believe their
company has the capability, of the 76 respondents that answered 67 believed their
companyhadthecapabilitieswhileonly9believedthattheydidnot.Therespondentswho
answered‘No’tothisquestionwerefurtheraskedwhytheybelievedthistobethecase.Of
the 9 that answered ‘No’, 3 common responses identified the lack of virtual tour
capabilities.
• ‘Virtualtoursneedworkinmycompany’
• ‘VirtualTourscapability’
• ‘Capabilitytoperformalivetourofourfacilities.Iwouldalsobeconcernedabout
poorqualityofvideo-callswhichcouldmakeinterviewsalittlemoredifficult.’
Figure10:ITCAPABILITIESFORREMOTEAUDITING
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10. Howdoyouthinkvirtualtoursshouldbeconducted?
Thisquestionwasusedtodeterminewhatrespondentsconsideredhowtoconductvirtual
tours. This question provided 4 identified options and provided an opportunity for
respondents to identify a specific opinion.Of the 76 respondents, 62 identified that ‘Live
videowalking around the site’ is the bestway to conduct a virtual tour. 12 respondents
selected‘pre-recordedvideos’asawayofconductingvirtualtours.
Figure11:THECONDUCTOFVIRTUALTOURS
Ofthe13specifiedopinions,7suggestedusingacombinationofmethodstoconductthat
virtualtourswhile4suggestedtheuseof‘smartglasses’asameansof‘livetour’toseethe
operatorsperforming.
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11. Doyouthinkthereisenoughguidancedocumentsonremoteauditing?
This question was asked to determine the industry’s perspective on remote auditing
guidancedocuments.Ofthe76peoplewhoansweredthisquestion47believedthereisnot
enoughguidancedocumentsfortheindustry.While21oftherespondentsdidnotknowif
there were enough guidance documents. Only 7 of the respondents believed there is
enoughguidancedocumentsonremoteauditing.
Figure12:REMOTEAUDITINGGUIDANCE
DiscussionRemote auditing has become more relevant since the onset of the global COVID-19
pandemic. Regulations on auditing in relation to GMP audits by regulators and the
regulationsinrelationtooutsourcedactivitiesidentifiesthelegalrequirementforauditsto
ensure the safety of drugs. However, the traditional approach of onsite audits is not
possibleatthistime.Thisrequirescompaniesandregulatorstoadoptnewwaysofworking
andauditingforcompliance.Asaresult,muchoftheguidanceonremoteauditingforthe
Pharmaceutical Industry was published the past year as the industry grappled with the
situationitfounditselfin.
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This researchhasshownthat the industrybelieves that there isa lackofguidanceonthe
topic.Duetoanunexpectedglobalpandemic,regulatorsandcompaniesmayhavebeenill-
prepared in their contingency plans to deal with its impact on auditing operations.
Regulatory agencies responded in short-term and published Q&A documents to address
someoftheindustryconcerns.
Sharingofdocumentationduringremoteauditingwasoneofthekeychallengeshighlighted
bytheindustry.Fromtheresultsoftheindustrysurvey42%ofrespondentsidentifiedtheir
companyhaving documentation available electronically,while 52%had a hybrid of paper
andelectronic copies. For thecompanies thathaveahybrid format, theywill still require
time tobe fullyprepared for remoteaudits. Thismay involve scanningofanydocuments
thatarenotavailableelectronically.
Sharing of documentation links into the challenge of data security concerns for industry.
28% of the respondents identified this as their biggest challengewhile 22% respondents
identified this as their second biggest challenge. Companies need to ensure confidential
information is not revealed unnecessarily through processes such as screen sharing. The
regulations for outsourcing activities state that contracts are required between two
companies, these contracts may now require an update to align with a remote auditing
process. These contracts will require addressing items such as confidentially agreements
andincludeinformationfortheremotesharingofdocumentation.
Conducting tours of a facility is an obvious challenge with remote auditing. It was
highlightedasachallengeintheindustrysurvey.Conductingofvirtualtourswasrankedthe
mostchallengingaspectof remoteauditingduring the IndustrySurvey.Fromthe industry
survey‘livevideo’wasexpressedasbeenthebestwaytoconductavirtualtour.‘Livevideo’
isputforwardasamethodtogivearealtimereviewofinspectedareasandmayallowfor
auditorstocommunicatewithpeoplewhoareonthetour.
Anotheraspectoftheresearchwastohighlightanybenefitsofremoteauditing.Thesurvey
highlighted the obvious benefits such as no requirement to travel to different countries,
reductionincostofanauditandenvironmentallymorefriendlyduetoreductionincarbon
footprint due to less air travel. Respondents during the survey also stated that remote
auditscanbemoreplannedinnature,whichcanleadtomoreefficientuseoftime.
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In summary, there aremany challenges faced by companies required to conduct or host
remoteaudits.Preparationwillbekeytominimisingsomeofthesechallenges.Tofacilitate
thisan‘ActionPlan’isproposed,thisactionplanjustfocusedonaidingcompaniesprepare
forremoteaudits.Theactionplanisdiscussedbelow.Itisalsoevidentthattechnologyisa
key enabler to conducting remote audits, without the correct technology and familiarity
withthistechnology,remoteauditswillnotbeeffective.Companiesandregulatorsneedto
move forward with this approach as a priority to ensure patients continue to receive
medicineswhileensuringcompliance.
ActionPlanInordertosuccessfullyconductaremoteauditonaserviceprovider/contactmanufacturer
thefollowingkeyactionsdetailedbelowneedtotakeplacethekeymessageispreparation
iskeytoasuccessfulaudit.
QualityRiskManagement tools suchas riskassessments shouldbecarriedoutbefore the
remoteaudit.Riskassessmentscanbeused todetermine ifanaudit isneedede.g.when
wasthepreviousauditandwhatwastheoutcome?Theriskassessmentshouldalsobeused
todeterminethescopeoftheaudit.
Once thescope isdefined theaudit teamshouldmeetanddiscuss the ITplatforms tobe
usedandifthereneedstobeavirtualtour.Asdiscussed,QualityAgreementsmayneedto
be updated if time permits, they should be updated prior to audit. If needed a
‘Memorandum of Understanding’ should be in place to define the confidentiality
agreement.
An important task to prepare for a remote audit is to ensure the training of staff on the
technologytobeused.Technicalissuescanhappen,andthemorefamiliarstaffarewiththe
ITplatformthesmoothertheauditingprocesswillbe.
A full actionplan canbe seenbelow. The tableoutlines a roughestimateof timelines to
adheretowhenplanninganaudit.Ideallyplanningshouldstartassoonasanotificationof
anauditisreceived.
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Action Timeline
RiskAssessmentØ Conduct Risk Assessment to determine if
anauditisrequiredorifanextensioncanbeconsidered.
Ø IncludethecriticallyoftheproductØ Lookatthelastauditreport.
Atleast8weeksoutfromaudit
HostPreagendameetingØ DiscussauditscopeØ DiscussLogistice.g.ITplatformsØ Discussifvirtualtoursarepossible.Ø DiscussQualityAgreements
6weeksoutfromaudit.
UpdateQualityAgreementØ Cover the scope of remote audits i.e
Screensharing, sharing of documentationelectronically.
Ø IncludeconfidentialityagreementØ If specific detail is included on frequency
ofauditingupdate.
6 weeks or as soon as there is an agreementbetweenbothsides.
PrepareAuditPlan/ScheduleØ Prepare a detail audit plan to provide to
theauditeeØ Provide the list of pre request
documentationwherepossible
4weeksoutfromaudit.
SiteAuditTeamMeetingØ Host training session with audit team to
discussITplatformØ Discussthescopeindetail
4/3Weeksoutfromaudit.
FinalPre-MeetingØ SendMeetinginvitesØ Trial Technology – Demo any technology
newtotheauditee.Ø Sharedetailedaudittimetable
1weekoutfromaudit.
Table1:RemoteAuditActionPlan
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Conclusion
In conclusion, there are many challenges faced by the pharmaceutical industry when
conducting/hostingremoteaudits.Withinthepharmaceuticalindustry,theauditingprocess
hashadthesameapproachformanyyearsandthesuddenimpactoftheglobalpandemic
forced the industry to adapt new ways of working. While remote auditing will not
completelyreplaceonsiteaudits,therewillnowbeanoptiontoconductremoteauditsviaa
risk-basedapproach.Itislikelythatthiswillbethe‘NewNorm’untilavaccineisapproved
forCovid-19,additional guidanceand legislation covering remoteauditswill benecessary
forthepharmaceuticalindustry.
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ReferencesBesson,C.etal.(2005)Theimportanceofnon-verbalcommunicationinprofessionalinterpretation.
CentersforDiseaseControlandPrevention(2020)SocialDistancing,Quarantine,andIsolation.
Availableat:https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/social-
distancing.html(Accessed:11November2020).
EMA(2020)UpdatetoguidanceonregulatoryexpectationsinthecontextofCOVID-19pandemic|
EuropeanMedicinesAgency.Availableat:https://www.ema.europa.eu/en/news/update-guidance-
regulatory-expectations-context-COVID-19-pandemic(Accessed:4July2020).
FDA(2020)Manufacturing,SupplyChain,andDrugInspections|COVID-19|FDA.Availableat:
https://www.fda.gov/drugs/coronavirus-COVID-19-drugs/manufacturing-supply-chain-and-drug-
inspections-COVID-19(Accessed:4July2020).
Grant,C.A.,Wallace,L.M.andSpurgeon,P.C.(2013)‘Anexplorationofthepsychologicalfactors
affectingremotee-worker’sjobeffectiveness,well-beingandwork-lifebalance’,EmployeeRelations,
35(5),pp.527–546.doi:10.1108/ER-08-2012-0059.
ICH(2015)CommitteeforHumanMedicinalProductsICHguidelineQ9onqualityriskmanagement.
Availableat:www.ema.europa.eu/contact(Accessed:23June2020).
Ireland,G.of(2020)gov.ie-ResilienceandRecovery2020-2021:PlanforLivingwithCOVID-19.
Availableat:https://www.gov.ie/en/publication/e5175-resilience-and-recovery-2020-2021-plan-for-
living-with-COVID-19/(Accessed:11November2020).
ISO(2018)ISO-ISO19011:2018-Guidelinesforauditingmanagementsystems.Availableat:
https://www.iso.org/standard/70017.html(Accessed:11November2020).
ISO(2020)ISO9001AuditingPracticesGroupGuidanceon:REMOTEAUDITS.Availableat:
https://committee.iso.org/files/live/sites/tc176/files/documents/ISO9001AuditingPracticesGroup
docs/AuditingGeneral/APG-Remote_Audits.pdf(Accessed:7July2020).
MedicinesAgency,E.(2020)‘QUESTIONSANDANSWERSONREGULATORYEXPECTATIONSFOR
MEDICINALPRODUCTSFORHUMANUSEDURINGTHECOVID-19PANDEMIC’.Availableat:
https://ec.europa.eu/health/sites/health/files/human-
use/docs/guidance_regulatory_covid19_en.pdf.
Short,J.,E.W.andB.C.(1976)‘TheSocialPsychologyofTelecommunications.’,Londan:Wiley.
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22
TammyAllen(2020)APSBackgrounderSeries:PsychologicalScienceandCOVID-19:Working
Remotely–AssociationforPsychologicalScience–APS.Availableat:
https://www.psychologicalscience.org/news/backgrounders/backgrounder-COVID-19-remote-
work.html(Accessed:22June2020).
WHO(2020)WHODirector-General’sopeningremarksatthemediabriefingonCOVID-19-11March
2020.Availableat:https://www.who.int/director-general/speeches/detail/who-director-general-s-
opening-remarks-at-the-media-briefing-on-COVID-19---11-march-2020(Accessed:11November
2020).
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