3 Korea MFDS - Osvaldo Lozada

8/11/2019 3 Korea MFDS - Osvaldo Lozada

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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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KOREANMFDS

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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KOREANMFDS

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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KOREANMFDS

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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KOREANMFDS

MFDA

Investigators

English

is

very

limited WesternHandshakeispopularinSouthKorea

BusinessCards:importantpartofintroduction

Receiveacardwithbothhands,readand

acknowled e contents kee on desk for duration

ofmeeting

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KOREANMFDS

Culturalaspects

Dietaryhabits:

Didnotrequestanyspecificmeals

Suggesttohavewhitericeandvegetablesinmenu

InspectionwasfullyledbytheLeadinspector

inspectionleader,andherrolewaslimitedto

documentreviewandwalkthrou hobserver

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KOREANMFDS

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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KOREANMFDS

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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KOREANMFDS


Focus

Areas

Manufacturing

Productmfg.stagessegregation

Rooms,equipmentandcorridorscleaning

Material/people

flow

controls

Equipment&utilitiesstate

Mfg.Equipment

HEPAfilters

Dustcollectionsystem

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Focus

Areas

Laboratories API&Rawmaterialsweighing/testingreports

MicrobiologyLabEnvironmentalMonitoring

ReserveSamplescontrolledcage

Containers,Room

Temperature RH

controls

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KOREANMFDS


Focus

Areas

Utilities PurifiedWater&HVAC

Spentmostofthetourtimeinspectingphysical

conditionsand

labelin

of

these

s stems

SystemsQualifications

HEPA filters verification ro ram

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KOREANMFDS

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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KOREANMFDS

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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KOREANMFDS

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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KOREANMFDS

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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3 Korea MFDS - Osvaldo Lozada

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Transcript of 3 Korea MFDS - Osvaldo Lozada