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rttlun,:AwuulJoun [t

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lu:r u nr :yrr n a rfi iu i'r wl fr n

:. do4anr:finu1Fr?1r.rn{anrvr6'o.ru{JuhnrlASEAN Guideline On Stabi[ity Study

Of Drug Productttau:'tu{1ulun:dfizuanr:6nurtrjlfluhnr:rdorirrauoilleritluorqv o a A d.j i

u 1 vr : o l.l rru't vl 1 { n 1 : n 1 Lfr u n'l : (Lu n 5 rilfr r fr o r rio.r )

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5. trzu u uta v/u6 o:r ur ru n rr rt:? aao ! n ? u o n olo rt o r n : v !? u n 1 : r,r fr sr t or an r ufi zu a

to urTlt rl6uuuilarlnu'l#rfl utrjnuRsEAN G uider.i ne on submission of

Manufacturing Process Val.idation Data for Drug Registration (uaurv"frroufi

rfiurrio.r)

o. do4ailialtfiuun:rdtLan{fl1:auarutorzufrnflruo{;rluutoru{trfrnirrJ:rrrudo!

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7. :vuu nr:riruuo:fi'arol{unr:zufr n (Lun: fi fi ifi urdo.r)

a. cio rir u u rur r a i 5'r u 1r o { r-n q n- I d'r u r rir 6'ry (lu n : fi fi r n' a.l do r )

9. nr:uoaolnr:fr nur:u uy L?a1n1:rfi l:"nur (Hol'ding time) torbut k pack lu:vv?1.in15 Lnuttaun'l51tud.t:u14?'t'iffnruvtzua nnnanruyt=l::Qa{n11Juy!i:Qfiale.iiaurrin oAA u( LunSruytnu?t0.t)

ltoutulunr:

6utoufftr

rrja^uu$da.:

1. nr:rfrrnr: overage rorr-nqfiun'rardrd'ryfrortriuflur.iaornnl:vrnaounr:6nrsr

n?r lJ n {aa 1il to.r ar fr n airu*{urrir r5 o :riU

z. dorirraurrillFl:51unt:rl:?ala'ouu6orirurfiodrrariruuavdoriruunrrn:oruoluul

r o.r zu a' n ri'rudu r 6'o ltri urj a' u u urj a rAv

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2. n r : x uJi u rr rfi u ! a n :r o r iu n r : ru 6 r r'ti':n o t1 ry r n ru rJ o l uiu ura v fi t o rr fflrrrJHuuru..Ja.l

3. nr:xurJiultfruu batch anatysis torzua'nfiruqi'arfit6'ilourulet ru floolYu rravfiI u i ---

4,irorrf[rurjfrrluuilat o"ruru 2 iu+. rarirf;oil:otzuanr:irn:ryvirorzufrrrfiruc{ur siruru z iufitourihuJf,auurjalt

s. rio|a nr:finurnru nranrn 6'ot rfl utrl pruRS rRN G uideli ne on stabit ity study

of Drug ProductLt6v:rutrulun:fifinranr:finrcrtilrflutil0rudorirraunlJ.l0t:s.ruo1u

ur (niolrruryrlnr:rir rfl unr:)

Non-AVG

MaV-2

n1:tv{iln1T overage

Non-AVG

MaV-3

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flryurnrrun{6n1nu1

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ar vr nfi'rdo n1:rnao! nluriorirrauqilr n:orufi ro urih uJ6uu urJar druru 2 junr:

ar fr nrjr i o I ra:*o qun r :ar 6 m

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B. rio4anr:finurnrun.,on'.tri6'r',,flutr.lmu ASEAN Guidel'ine on stabiLity study

of Drug Product uav :ralrulun:nifizuanr:rt'nrgrhjrflutrjntrtiorirrauoil'tn:01uo1u4t

or (vr io:r uuryrr nr:rir rfr unr:)

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outslud

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Non-AVG

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rfiarriot)

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iaunl5Lv{iltu9t?i

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tY}J'IUfi}J

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i q ,: -,"-;-"-."" t---i'-' ts

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q. ,rnu'.rr,i'.rnluorutasaarnd.r:rld.:fitorrri'ltrrjFuuur..Jal([un:fifiufiurdol)

s. {ola nr:fi nur nr}.t nounlr 6'ro,ttuhj nuRSEnN G uide l.i ne on Stability Study

Of Drug ProductLrfiy:rulrulun:fifir,ranr:finrgrlrirflutlnrrriorirvuoilln:5'luo'lq

or (r,r iol utu'rvrq nr:rir tfi unr:)

6. ronali P 7 nrlrin'oua-ninruvinr:duvrrrfluun'riluruuu ASEAN (ACTD) fito

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fioultlud

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.;LUAUULL!A.I

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rfluhjnr:r ASEAN Guideline On Stabil.ity Study Of Drug Productttau:'lU{lulu

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rfiorJ:snounr:

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J[Y'lOU:Un0Un1:

t. yrirf,oir:o{ CEP nfortonar:u' oonlfru European Directorate

for the Quatity of medicines (EDQM)

z. {o rir vu n }r 1 or :o1 u1r o'1 ?-n q A ! n-'r u'r rir 6'ry 0u n : nifi rfr u r dor )

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rtttunr:Jquuljoun tfl

rujdtruurilar

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d,\,vod4dlrlju LU Fl',tlJ10 n1uuo01 t{ uu 14:0 tvl u1j tvll

z. rflunr:rui'lrur.Jduurula.:fif;urflo.rlra']nn1:tileuutda{Lona1:rirfiiurtotarv,fiutiuu (origina[ drugs)

3. n:fironar:rirfiuorro.r{zufinlurJ:vtvrfi (vrvtf,uuzu6nviour-jr!:rnu16'utt1JlJ

(original. drugs) raion:firy'rira''rr firfluvrvrCuuer'rr-uurfifido4arrafiousir:nurfitdil! a qv v q Af,uvrvrflauliudr'Luf,onr:rirlvri to{urfrurlu (originaI drugs) rirvunrl#tonar:

YAn r n u u'r Fr o.r r1iil o u n ull n | 5 u n 1 : u n t{ufi o n r : firlrailtu vr v tfi u u u r

1 . a a 1 n rra u ro n a r : rir rYu u r arir fi t6':-r o u tu'r Ft ru rJ t o liutu i

2. a a 1 n tta v ro n a 1 : ril nl1l u r fi t o ur ff1t uJ 6 u u ini a I

3. ro n a1 : uta a { ru r] r,r alunl i? o rLfi'[r rl 6 u u utl arI

4. ronar:rirfi!ur (Package insert) doqaalJtolzu6nfiruc{mr:JLL!I..J Summary of

Product Characteristtcs (SmPC) u6oronar:rirnluurdrvir{thu fiLil:-loqtu'lnto.idouyrvrtousiriuurduuur (original.) rravdrrurrirtoiui'hui6uuru.Ja'rfi16'ilo1.{ry1rrx1n

drrinrrunruv nr:! nlio'r1i1: lrau u'r

s. vrir f; o 0 u u o l.r a 1 n ri"rr o': zu fr n rYrucfll#dr r 6 t ro n a r : rir riu u r

JJuu[v'l0

rJ:vnounr:

v{Q15[U1

14lJ''ru[14sr n:finr:eir:ru{lurJanlrai?aaoun?r}Jnn6'ottorn:vurunr:26n (Process val.idationt!

report) r,ld'.rornkiiuhrirrYrynr:rsuvrrru^uuuru#r trid'qr{Ju nr:uritturJf;uuutla.i:1unr:vvuiuum"r:-uur

trin'ruflunr:lirrari.rf;ofi.rrirrinur rvl'orir:rurrurianl:n:?aaounrunn6'o.rllo.iniu!?unr:26n (Process

Val'idation report)