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KOREANMFDS
PresentationTopics
Notificationof
Inspection
InspectionCosts
PreInspection
CulturalAspects
InspectionOpeningMeeting
FacilityWalkthroughs FocusAreas
GeneralInspectionProceedings
Response
ProductApprovalTimelines
InspectionHighlightsSummary
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KOREANMFDS
TheAgency
1996as
the
Korea
Food
and
Drug
Safety
AgencyvisionandpurposesimilartoUSFDA:
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Notificationof
Inspection
Inspectiontriggered
by
anew
product
filing.
OurRe ulator Affairscollea ueinKorea
servedasourliaisonwiththeagency.
inspectiondaysforthePAI.
.
Inspectorsnames(2)notifiedinadvance.
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Notificationof
Inspection
nspect onpurpose:
InspectionDates: February1821,2013
Two(2)InspectorsofthePharmaceutical
QualityManagement
Division
TheLeadInspectorwastheScientificReviewer assignedto
ourNDA
Consideredanational
expert
in
GMP
facilities
and
utilities
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InspectionCosts
InspectionarrangedandcostspaidbyMerck.
Agencyrequiredbudgetlimits:
Travel:Specificflightsselectedbyinspectors
Hotel:
105
USD/night
(w taxes,
WIFI,
breakfast)
Meals: 49USDpereachinspector
Dail roundtrans ortationwithMerckSecurit
Dailyallowance:26USDpereachinspector
InspectionfeepaidbyMerck:$10,500
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PreInspection
Preinspection
checklist
received
translatorsbytheagency
mfg.processinoperation
a yexten e
nspect on
t me
per o
request
Noinspectionagendaprovided
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PreInspection
eta e sto ocumentsrequeste a out
monthspriortoinspectionMultipledrawings(facilities,operations,productmfg.
processflow,water/airsystems,labs.,etc.)
, ,
yeardata/trendanalysis
Training(Operators,QAandLabs)
Organizationalcharts
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PreInspection
eta e sto ocumentsrequeste a out
monthspriorinspection(continued)MultipleSOPs(Environmental,Training,PestControl,
DocumentationMgt.,ChangeControl,Internal/Supplier
Audits,Retention
Sam les,
Micro,
Sam lin ,
Stabilit ,
Deviations, OOS,APR,Complaints,Recall,packaging,
disposition,etc.)
a a on
as er
an,
rocess
a a on,
a c
recor s,Bulkproductholdtime
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MFDA
Investigators
English
is
very
limited WesternHandshakeispopularinSouthKorea
BusinessCards:importantpartofintroduction
Receiveacardwithbothhands,readand
acknowled e contents kee on desk for duration
ofmeeting
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Culturalaspects
Dietaryhabits:
Didnotrequestanyspecificmeals
Suggesttohavewhitericeandvegetablesinmenu
InspectionwasfullyledbytheLeadinspector
inspectionleader,andherrolewaslimitedto
documentreviewandwalkthrou hobserver
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InspectionOpening
Meeting
Openingmeeting
agenda
followed:
1. Introductions Ledbythehost
Exchangebusinesscards
Roundtable
introductions
SiteSr.Mgt.,Translators,ScribeandHost
2. GeneralSitepresentation BysiteGM
3. Productpresentation
By
product
technical
lead
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InspectionOpening
Meeting
4. Noagency
presentation
offered
by
the
inspectors
5. Agreedinspectionitemsfor1st day:
Reviewof
drawings
sent
in
advance
such
as:
Productmfg.facilities
Personnelandmaterialsflow
HVAC/PurifiedWaters stems
Facilitytour
(11:00
AM)
Fullproductprocessflow(chronologicalorder)
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FacilityWalkthroughs
Focus
Areas
WarehouseExternalairparticlescontrols
Pestcontrol
Productmaterialmovementprocess
APIReceiving/Storage/Weighing/Disposition
Qualityincoming
sampling
room
controls
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FacilityWalkthroughs
Focus
Areas
Manufacturing
Productmfg.stagessegregation
Rooms,equipmentandcorridorscleaning
Material/people
flow
controls
Equipment&utilitiesstate
Mfg.Equipment
HEPAfilters
Dustcollectionsystem
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FacilityWalkthroughs
Focus
Areas
Laboratories API&Rawmaterialsweighing/testingreports
MicrobiologyLabEnvironmentalMonitoring
ReserveSamplescontrolledcage
Containers,Room
Temperature RH
controls
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FacilityWalkthroughs
Focus
Areas
Utilities PurifiedWater&HVAC
Spentmostofthetourtimeinspectingphysical
conditionsand
labelin
of
these
s stems
SystemsQualifications
HEPA filters verification ro ram
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GeneralInspection
Proceedings
a yexten e nspect ont meper o s
8:30AM arrivaltosite
7:00PM 8:00PMdeparturetime
Mostof
the
time
during
the
four
inspection
dayswerespentinfacilitywalkthroughs
Inspectorsdidnotsplitduringtours
Noformal
daily
wrap
ups
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InspectionClosure
Briefagencypresentationoffered
Agencygeneralinformation/goals
Reportandresponseprocess
Inspectionreport
should
be
received
in
23weeks
Responsereportmustincludecompletedactionsand
evidences
productapproval
will
then
be
determined.
Presentationelectronicfilenotshared
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InspectionClosure
observations/concernsin
closure
meeting
e r a y o ra treportprov e
Few
minor
observations
mostly
related
to
facilities
u
Observationsnotcategorizedwhenmentioned
oexpectat ons
o
s
n cate
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Response
Translatedto
English
in
2days
Very
long
response
process
Ledbetweensitehost&MerckKoreaLiaison
(Leadtranslator) withtheKFDA
a sonca e
e
ea
nspec orsevera
mes
an
visitedhimintheKFDAofficestwicetoreview
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Response
Leadinspector
requested
to
revise
response
re orttoaddmoreevidenceofcom leted
actionsasattachments:
AllBefore
and
After
Pictures,SOPs,drawings,reports
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ProductApproval
Timeline
NDA
submitted to KFDA 0
KFDAinspection 6
Originalresponseissued 9
ev se response ssue
KFDArequestedadditional
evidences
11
Responsefinally accepted 12
NDAapprovedbyMFDS 13
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InspectionHighlights
Summary
n ro uc ons us nesscar spro oco
Facilitywalkthroughswithproductinoperations g. tagesroomssegregat on
Facilities&equipment
Watchfortheinspectorsbodylanguage!
Noformaldailywrapups
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Thankyou!
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