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WeareplanningtorevisetheGSOPandrequestyoutopreparethelocalSOP.

Weknowitsagreatburdenforyou.

We

also

understand,

in

some

OIAA

companies,

Local

SOP

has

been

just

revised.HoweverOPFhastorequestit.

Weaskforyourunderstandingandcooperation.

Iwouldliketoexplainthepurposeaboutthat.

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OPFstartedPVauditofOIAAcompanieslastyear.

ThreeOIAAcompanieshavereceivedthePVaudit.

OPF

PV

and

LSM

received

some

findings.SomearecommoninotherOIAAcompanies.

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First,itbecameclearthattherewasnolocalSOPofprocessingsafetyinformation

concerningOPFMPs(PVAMPsandNPVAMPs).

It

was

one

of

major

findings.Whatisyourcompanyssituation?

YouneedtopreparethelocalPVSOPaboutOPFsMPsifyoudonthaveit.

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Nextissueisconcerningcasehandling.

Thereweresomemistakesinsafetyreportform.

It

was

also

major

finding.Ofcourse,nobodyisperfect.

ButtoestablishPVsystemwhichpreventsoccurrenceofmistakeisveryimportant.

ThesecheckproceduresareaddedintorevisedOPFGSOP.

Udasanwillexplainindetail.

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Wedontdescribe detailedprocedureinGSOPbecausethesituationsdifferineach

OIAAcompany.

Particularly,

you

need

to

specify

the

procedure

of processing

safety

information

in

your

LocalSOP

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LetmeremindyouofbasicpolicyofOPF.

OPFiscommittedtomanagingthesafetyandqualityofmedicinalproductsinOIAA.

As

you

know,

there

are

two

type

of

MPs,

OPF

products

and

local

products.WhydoesOPFcollectthesafetyinformationaboutlocalproducts,too?

ItisbecausethereistheriskmanagementconsiderationsintheOPFspolicy.

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Iwillexplain anincidentthataffectedthecurrentOPFspolicy.

Theincidentiscontaminationproblemofheparinproductsin2008.

At first,

the

report

noted

an

increase

in

allergic

reaction.However,finallycontaminatedheparinproductscausedsomecasesofdeath.

Thatbecameabigproblem whichaffectedseveralareas.

OPFhadrecognized thatqualitydefectofinjectionsolutionproductssometimescauses

seriousproblems.

ThiseventmadeabigimpactontheOPFriskmanagementpolicy.

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Welearnedsomelessons.

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ClarisOtsuka becameamemberofOIAAthisyear.

Now,,thenumber ofOPFs affiliatescompaniesis12.

Exports

and

imports

between

OIAA

companies

increase..Ifqualitydefectswithsafetyproblemsoccur,whicharenolongerlimitedwithinone

country/area.

Delayofresponsecausesexpand of damages

Pleaseestablishthesystemofprocessingsafetyinformationandensuretheintegrity

Inordertodothat,itisnecessaryforyoutopreparelocalPVSOP.

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Iwouldliketointroduce anactualexample.

Fortunatelythisisa casecausedinothercompany.

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Thesequalityproblemsareconfirmedbyauthority.

The companyreceivedbusinesssuspensionorderandtheproductsarerecalled.

In

this

way,

quality

defect

of

injection

solution

products

sometimes emerged

as

safety

problemandcauseseriousproblems.

Therefore, itisimportanttotreatthesafetyinformationinappropriatemannerfromthe

viewpointofriskmanagement.

Also,ifADRreports dontbereportedaccordingtotheregulation,thecompanymay

receive administrativemeasure.

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Iintroduceanactualexampleaboutadministrativemeasureagainstviolationsof

obligationtoADR.

There

are

212

violations

of

ADR

reporting

obligation in

Pfizer.93MRsdidntreporttheADRs occurred.

TherearentproblemsinyourPVsystem,arethey?

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Ofcourse youknowverywell.

Buthowisotheremployee?

Other

employees

may

get

safety

information

unconsciously.Becausetherearevarioussourcesofsafetyinformation.

PVtrainingforotheremployeesis important.

ToestablishthePVsysteminwhichthesafetyinformationobtainedinyourcompanyis

surelyreportedtoLSMisimportant,too.

ThisishottopicinJapan, too.

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WeareoneOtsuka.

Ifyourcompanylosescustomerstrust,otherOtsukacompaniesareaffected.

Management

of

quality

and

safety

is

a

mission

of

pharmaceutical factory.AppropriateprocessingofsafetyinformationisamissionofLSM.

WeconsiderthattheLPVSOPisessentialfor establishingappropriatePVsystem

CouldyouunderstandwhythelocalSOPsarenecessary?

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IwouldliketoexplainfuturepolicyofOPFaboutLocalPVSOPandGlobalPVSOP.

As youknow,weneedtoconsidertherelationshipofOIAA,OPFandOPC.

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OPCisthebiggestglobalcompanyinOtsukagroup.

NineOIAAcompaniessellbothOPCproductsandOPFproducts.

One

LSM

is

in

charge

of

PV

work

for

both

OPC

products

and

OPF

products.Ontheotherhand,therearethreeOIAAcompaniesnotrelatedOPC.

Atthepresent,theGSOPsdufferinOPF andOPC.

Therefore,therearetwostandardsinsuchOIAAcompanies.

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Thebasicpolicy of OPFGSOPisharmonizingwithOPCGSOP.

However,atthisstage,OPFPVsystemcouldntbeadjustedwiththatofOPC.

We

are

aiming

to

improve

efficiency

of

the

PV

work

in

OIAA.SomeOIAAcompaniedmanagedbyOPChavebeenimplementedOPClocalSOP.

Wewouldliketoavoiddoublestandard.

Weattemptto standardizetheLocalSOPasmuchaswecan.

WewillsupporteachOIAAcompanyconsideringthesituation.

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Iwill explainhowtopreparetheLSOP.

OPFpreparetwotemplates.

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WehavediscussedLSOPwithKOIAAwhichmediatesbetweenOPCandOIAA.

WeaimtointegrateOPFprocedureintocurrentOIAAlocalSOP incooperationwith

KOIAA.ThismeansthatyouwillspecifyOPFsMPintocurrentLocalSOPandtreatOPFsMPin

thesamePVsystemasOPC.

Inthatcase,therearetwobigdifferences.

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First,thedefinitionofsafetyinformationis entirelydifferentbetweenOPFGSOPand

OPCGSOP.

In

the

current

policy of

OPF,

we

collect

only

adverse

events

or

suspicion

thereof

and

so

on.

But,ifyourlocalPVsystemis establishedwiththisdefinitionofsafetyinformation,it

wouldbebetterthatyoutreatOPFproductswithsamedefinition inyourLSOP.

OPFconsiderthatisnoproblembecausethedefinitionincludessafetyinformation

necessaryfor OPF.

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Secondly,thetimelineisalsodifferent.

In thepresentOPFPVsystem,thetimelinecouldntbechanged.

Also,

OIAA

not

related

to

OPC

may

not

use

such

strict

timeline.Ontheotherhand,therearetwotimelinesinOIAAcompaniesrelatedtobothOPCand

OPF.

Itmaybeacauseforconfusion,iftherearetwostandardsinonecompany.

The timelineofOPCismorestrict thanthatofOPF.

Therefore,itisOKthatyoutreatOPFsMPusingthetimelineofOPCwhenweconsider

topreparethelocalSOP.

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OPFwillprepareanewtemplatewherethecurrenttemplateoflocalSOPandtheOPF

procedureareintegrated.

After

the

review

by

KOIAA,

OPF

will

provide

the

new

template

to

OIAA

companies

relatedtoOPC.

PleasepreparethelocalSOPbasedonthetemplateconsideringyoursituation.

WeunderstandthattheOIAAcompaniesrelatedtoOPChavejustfinishedrevisingtheL

SOP.

Wekindlyaskforyourunderstanding.

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InthecaseofOIAAcompaniesnotrelatedtoOPC,thesituationmayvary withineach

company.

OPF

provides

the

template

of

the

version

not

related

to

OPC's

template.Youcanuseitasnecessary.

OrifyoualreadyhavetheLSOPinyourcompany,youcanalsointegrateOPFprocedure

intothecurrentLSOP.

Ontheotherhand,wearealsoplanningtoreviseOPFGSOP.

Inanycase,pleasereflectthecontentsofrevisionofOPFGSOPintheLSOP.

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Iwould liketoexplainthepointsofrevisionofGSOP.

AuditoralsopointedoutthatthereweresomeinappropriatepartsinOPFGlobalPVSOP.

We

revise

OPF

G

SOP

in

response

to

the

findings.ThemainrevisionpointsareQCcheck,duplicatecheck,followup,PVAtemplate,

definitionofDay0,sourceofsafetyinformation.

KumesanandUdasanwillalsoexplainthedetail,Iwillgiveasupplementary

explanation.

WedontdescribedetailedprocedureinOPFGSOP.

So,youneedtodescribetheprocedureinyourLSOPindetail.

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ThechangeofthedefinitionofDay0 willaffectthissituation.

Inthecurrentdefinition,Day0isthedatewhenanemployeeofOtsukareceivesacase

report

that

fulfills

minimum

criteria

defined

in

the

ICH

E2D.After revision,Day0isthedatewhenanemployeeofOtsukaorpartnercompaniesfirst

receivesacasereportthatfulfillsminimumcriteriadefinedintheICHE2D.

ThischangeisourefforttowardtheestablishmentofglobalizedPVsystem.

ThischangewillaffectPVagreementandreportingtimeline.

Kumesanwillexplainindetail.

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Asyouknow,theflowofsafetyinformationbecomescomplicatedwhenthereare

export/import relationshipbetweenOIAAcompanies.

There

is

no

change

in

these procedure,

but

we

add

explanations

in

the

revised

G

SOP.BecausewereceivedPVaudit findings.

Iwill explainitjustincase.

OIAAhastoreportSRFtoOPFwithin2or4calendardays.

OPFneedtoprovideacknowledgement andcasenumberwithin1workingday.

ButOIAA CalsoneedstosendtheSRFtoOIAABwhichismanufacturerinthiscase.

ThisreportisrequiredbasedonOPFGSOPandthePVagreementbetweenOIAABand

OIAAC.

Ontheotherhand, OIAABasmanufacturerneedstoforwardtheSRFtoOPF.

Followupisalsocomplicated.

Udasanwillexplainindetail.

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Finally,IwillshowthescheduleforconsideringlocalSOP.

WeaimtostarttheLocalSOPinApril2016.

OPF

will

prepare

the

template

and

provide

it with

revised

G

SOP

to

OIAA

in

Dec

2015.OIAAwillpreparethedraftofLSOPbytheendofFeb2016.

OPFwillreviewthedraftandOIAAwillfinalize itinMar2016.

OIAAwillstarttheLSOP bytheendofApr2016 aftertraining.

GSOPwillbeeffectiveonApril1st.

Weaskforyourunderstandingandcooperation.

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