MappingDocumentforISPESpecificationandVerificationGuides

Introduction
ThisdocumentexplainstherelationshipbetweenthefollowingISPEGuides:
ISPEBaselineGuide,Volume5:CommissioningandQualification1(BaselineGuideVolume5)
ISPEGuide:ScienceandRiskBasedApproachfortheDeliveryofFacilities,Systems,and
Equipment2(FSEGuide)
ISPEGoodPracticeGuide:AppliedRiskManagementinCommissioningandQualification3
(AppliedRiskManagementGuide)

Overview
BaselineGuideVolume5representsestablished,baselinepractice.Thisapproachachievesadequate
complianceinaneffectiveway,butdoesntfullyleveragethelatestQualitybyDesign(QbD)andrisk
basedconcepts.
TheFSEGuidedescribesacomprehensiveandstrategicscienceandriskbasedapproach,focused
onQualitybyDesign,andbasedonfitnessforintendeduse.Itreflectsthelatestindustryand
regulatorythinking,byfocusingontheaspectsmostcriticaltoproductqualityandpatientsafety.
TheAppliedRiskManagementGuidedescribeshoworganizationscanmovefromestablished
baselinepracticetoamoreefficientscienceandriskbasedframework.Itdescribesatransition
strategyandhelpscompaniestojudgethebestandmosteffectivepathforwardforthem.

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ObjectivesoftheGuides
1. ISPEBaselineGuide,Volume5:CommissioningandQualification
ThisGuide(BaselineGuideVolume5)focusesontheengineeringapproachesandpracticesinvolved
inprovidingcosteffectivemanufacturingfacilitiesinatimelymannerthatmeettheirintended
purposes.Specifically,theGuideaddressestheprocessofdesigning,constructing,commissioning,
andqualifyingthefacilities,utilities,andequipmentregulatedbytheUSFDAorotherhealth
authorities.
Itappliesaprocessofimpactassessmentwithsubsequentenhanceddesignreviewandqualification
asappropriate.
2. ISPEGuide:ScienceandRiskBasedApproachfortheDeliveryofFacilities,Systems,
andEquipment
ThisGuide(FSEGuide)providesdirectiontoindustryontheimplementationofascienceandrisk
basedapproachfordemonstratingthatpharmaceuticalandbiopharmaceuticalfacilities,systems,
equipment,andassociatedautomationarefitforintendeduse.ThisGuideisintendedtobe
compatiblewithInternationalConferenceonHarmonisation(ICH)GuidesQ8(R2),Q9,andQ10,4,5,6
andtheASTMStandardE250007StandardGuide.7
Thesepublicationsemphasizetheimportanceofsciencebasedprocessunderstandingandtheuse
ofriskmanagementprinciplestofocusonaspectscriticaltoproductqualityandpatientsafety.
3. ISPEGoodPracticeGuide:AppliedRiskManagementinCommissioningand
Qualification
ThisGuide(AppliedRiskManagementGuide)describestheapplicationofQualityRiskManagement
totraditionalCommissioningandQualification(C&Q)practices.Itlinksthetraditionalterminology
andapproachesofC&Q(asusedinBaselineGuideVolume5)tothenewerscienceandriskbased
specificationandverificationterminologyandapproachesappliedintheFSEGuide,andother
documentssuchasICHQ95andASTME2500.7

ComparisonoftheGuides

Topic
Terminology

BaselineGuide
Volume5
TraditionalC&Q

Adoption

Traditional/established TransitionalStrategy

Organization

Traditional/established Transitionbasedon
maturity
ImpactAssessment
QualitativeRisk
Assessmentbasedon
productknowledge
Compliancefocus
ProductQualityfocus

RiskAssessment

Regulatory

AppliedRisk
ManagementGuide
TraditionalC&Q

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FSEGuide
Specificationand
Verification
Immediate
implementation
ASTME2500roles/
responsibilitiesinplace
IntegratedQRMbased
onICHQ9
Patientsafetyfocus

AdvantagesofaScienceandRiskBasedApproach
ApplicationofaScienceandRiskBasedApproachencouragestheindustryandindividual
organizationstoreassesstheterminology,practices,androlesandresponsibilitiesinvolvedin
deliveringnewmanufacturingcapacitytofocusonthecriteriarequiredtoestablishsuitabilityfor
intendeduse.
Riskmanagementapproachesbasedonanalyzingrisktopatientsafetyandproductqualityprovides
betterdefinitionofcriticalaspects,andmaysaveeffortinexecution(versussystemandcomponent
impactassessment).Otherbenefitsinclude:
Improvementsindesigntomeetsciencebasedprocessrequirements,andimproved
effectivenessandlowercostofinspectionsandtesting.
Efficientandfocuseduseofresources,ensuringtheyaredirectedtoqualitycriticalaspects
andactivities.
Better application of resources and better conformance to GxP regulations, due to the clarification of the
roles of Quality Assurance (QA) and Subject Matter Experts (SMEs).

RoleoftheAppliedRiskManagementGuide
TheISPEGoodPracticeGuide:AppliedRiskManagementinCommissioningandQualificationaimsto
assistcompaniestoachievethesebenefits,bymovingfromtraditionalapproachestowardafully
scienceandriskbasedapproach.Itdoesthisby:
describingtheapplicationofQualityRiskManagement(QRM)totraditionalC&Qpractices
linkingthetraditionalterminologyofC&Q(asusedinBaselineGuideVolume5)tothe
VerificationterminologyoftheFSEGuideandASTME2500
outliningbridgingstrategiesfororganizationswithwellestablishedQualificationbasedQuality
ManagementSystems
providingaroadmapshowingthespectrumofpotentialapproachesformovingfromthe
approachdescribedinBaselineGuideVolume5tothatsuggestedintheFSEGuide,ASTME2500,
andICHQ9

ATransitionalStrategy
ATransitionalStrategyisdescribedintheAppliedRiskManagementGuide,reflectingthatthefull
frameworkofapproachesdescribedintheFSEGuidemaynotbeimmediatelyachievableinall
organizations.
ThefullscienceandriskbasedapproachasdescribedintheFSEGuidehasprerequisitesfor
effectiveimplementation,anditmaytaketimeforanorganizationtoputtheseinplace.
TraditionalterminologyandconceptsareoftenembeddedinQualityManagementSystems.
ChangingtheQMSmustbedonecarefully,andwithinputfromappropriatestakeholders,while
ensuringcontinuedcompliance.

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Existingdocumentsandtemplatesmustbetakenintoconsideration,andchangesmayrequire
significanttimeandcost.Asprocesses,documents,andtemplatesarechanging,theorganization
willstillrequirepracticalapproachesandtools,suchasclassificationsystems,forongoingprojects.
Adoptingthescienceandriskbasedapproachwillbringlongtermbenefit,buttheshorttermday
todaybusinessneedsmustalsobeconsidered.
Strategically,however,theregulatoryexpectationsforadoptionofQualityRiskManagement
approachesarebecomingveryclear.Thisrequirementwillincreasinglyleadtopurelytraditional
approachesbecomingnoncompliantaswellasnoncompetitiveovertime.

WhichApproachtoTake?
Giventhemajorbenefitsofadoptionofthescienceandriskbasedapproach,shouldaparticular
organizationimmediatelyadopttheFSEGuideapproach?Orshoulditadoptatransitionalstrategy
formovingfromatraditionalC&Qapproach,byfollowingtheAppliedRiskManagementGuide?
Thefollowingtablewillassistorganizationsindecidingwhichapproachissuitableforthem.
AdoptFSEGuideImmediately
NeworflexibleQualitySystems
Withoutsignificantlegacy
terminology/mechanisms

FollowAppliedRiskManagementGuide
TransitionalApproach
EstablishedQualitySystems

Embeddedterminology

Organizationallycapable

Nonriskbasedculture

Organizationalmaturitycurve

References
1. ISPEBaselineGuide,Volume5:CommissioningandQualification.
2. ISPEGuide:ScienceandRiskBasedApproachfortheDeliveryofFacilities,Systems,and
Equipment.
3. ISPEGoodPracticeGuide:AppliedRiskManagementinCommissioningandQualification.
4. PharmaceuticalDevelopmentQ8(R2),InternationalConferenceonHarmonisationof
TechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse(ICH).
5. QualityRiskManagementQ9,InternationalConferenceonHarmonisationofTechnical
RequirementsforRegistrationofPharmaceuticalsforHumanUse(ICH).
6. PharmaceuticalQualitySystemQ10,InternationalConferenceonHarmonisationof
TechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse(ICH),
www.ich.org.
7. ASTME250007StandardGuideforSpecification,Design,andVerificationof
PharmaceuticalandBiopharmaceuticalManufacturingSystemsandEquipment.

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