Requirements for Measles, mumps and rubella vaccines and combined vaccines, live, TRS No ...

102 Pages·2002·7.62 MB·English

Annex 3
Requirements for measles, mumps and rubella
vaccines and combined vaccine (Ilve}

jostanees Ne, AP;

ear

saci ome en be
1 Hecuirernontstr meaates vaccine ws
Canara waroeken on is

Sten nd hii

art Neen onl equre-ents kon
Picea te
1. Requlramonts for amps vaccine 11
cereal amidst Br

Pari Moesfackeng scuirorrans
Tenn ies, fe yon sae pecten

a rau fecuigy sre

rogue gost

sealing
ie ats acs
1 Sie age end ea

3
Bigs

E> Rees so ae

1. Recwirmants for ubelavaclne

Gens care seaors

BR aeore wanibentng surerevs

Ar Tyee

20 ea tiga
Stew: ora

1. Reguiroment for meable-mumpe-rubell (HN) combined vaccine

‘oer onsidoratone

Par: A, Manuactunng squtomants

22 Sarco a fer be si

4 Grp setae tne ws

Fart Nana contents

seceivie 1

Eholy prea yor aneaing se rasla ase “ee
‘aren fr uma” ini ve wed fr he production of ease

Propaeed assay mere for deter 9 hey oss aw reese vacere
Peerney
ial erent for rebsav cf weve tumoa, bells coritinedvace coe 1

Suma protec! restucton ana esting of ur as ere th

‘pperss:
Proposed sey tethering the iusto nme vane |

pens
lini eae for pro soton se wl fmt vacant we

Proceaedazsay neta Ky oloar‘ang he ts santana hs ube cine 196

Strmnry sto o> (raheto® and aaing 2 measles rls
‘tina vaca og ter
rapid assay mathe fr determi“ te visita fra
Fella cortinedise ee

Introduction

[Comino tive wizeine foe measles, mumps and “sll (MMR is used
site for eke fmmunizalion of uke In ceerain reams of the werd
IBecnnse ofits advamnaes ower ln ndividne® eaeeines. (Combined vaceine
provokes an adequate uate cexamaeninchildeon smultimccusty orth
Cece mtections inl fists he eaplomentition of current inubea

Measles
‘Measles isan etm mnariable elie expeence at childhood. se
colfen a sonore chicas, Irequeaily vompligated hy mitdleenr“alection ve

Iwnniehooncumonis, fn souue countries Ife maxor cause of ices sud
leah, Eneephalis ooeurs i sprosimately one of every 2000 reported
foaton, ainivora fleu have petmetant rxin amie and neu
Fetmrdation. Deal, predurofsandy trams rewpirsun:y and seurulogical
scr wou ia our el every AN0K! reported meas euees, The 1

deaths groale for ius andl adults than for eldren and adlesvents

Cuntexsting, mows es uring preguaucy increases total sk. Must
‘county hs sk incoles netastire late and moderatsy aesonsed
rates o) spentancans ehertga aud fle ich seg

Ssnhaence~elerosing pet cephalte, alow wares in“eetiom ofthe central
snorwomeeyetem, is anced ic pions c8 virus. Hi marty that
the United Sint of America. wdexptead nse tm sles sucene has ke ts
{he vir dltagpearance sf his nietion.

Immunization aguas ances has hen of inksrest ka WIIG Jat many
yams om expecially since the Fpl Prugrarame on Exanunization
vaasluunchod in 1974 ses nesses anions afte iui diseases ayzinn
sil it wine dineted, cu spos: of the ima uuiealion,acoKramme.
selerenco materia 1 ueraecsles rum ans mths vce virus
been estes. The Reeuizestents for Megs Wietine i)
aulepic By ce WFO Eapest Commitee on Blesical Standart a
866A, war an AaMaulL in 1981 te Hnelnae an seveleited las her
jhihiy (2. Since he wil pvatactom of mogales sagcine he seaTeh
Isrirmproveel nwt ger as som

The bot sevisie: of the RopSromcaTs Zan Mewes Vane (Laws) 08
Andee Uy dhe WIL xp Comat eu Biskney. Nema in
11S sat evisu ame eas ak of lis apap nes
oF fe Tegulaions sad rsjaremenes far Tbe auiulrctare aml conned oF
nistales saeeii Ul ad he farmnlate a nuuberof snares ane oF
Informunion “iat 3.Liishedl aris unpablishel sruzcss. Lor the proser
evs Reqerie-ts pus ise! together eC Urea Reames for
Commpinon Weerige, Sunes shamges has "Joes made U9 The previous

Murs

Musxps w an aoste acase of childron and rota eulls, onused m6
parumyscvims of whic Une is nly a siigie secolspe, Stamps vite
Drodusesiioaymptousinatsoat ons thint of infected pen. Inthose with
aactaiou response, shouululerane nore tse eare aoa olen allected 1
2aoss eomimos aigns ave ever and sesling of ibe justi glands, ther
couplicatians. which cay spear imal cemsly wit eve orn
saqueme, ane epidicdyuc~occhl. moningorenceplsliis. crcuel saree
invelvemont fespectay eighth cramal raree dame ‘ening be tring
impairmesn, psncwells. consort, masitis wal ayers, Freee
‘ruin and abing-al ual seen sugges Pa uuu virus a eer

f halnzys. n sre btanves. ons oF mers ofthe aller compbenrns
say be present in Re luge of Ha

he met coumpon compl ereow uf sawp in chiles i ain,
somotines asucinte wie" ene pha, abe cus lisa, WS

msiraiios cue a1 momps infestioa. sesuive frou perienant
Sdamine. Daal Jellossate srumps 18 rH ace Hf cael sue To Ms
fenceann is. Muy peuple each telhoad tho 2 developing mnie
dnd povral reget poaultins ls frsamm7et ow imo alae bos
riklren me sge9pcUe ws,

The Requinesrurss for Snape Vasc fs saree by the WA
Expect Commies an isligioe! Stuslurdvavios in 198774, aud Save
‘bees tolled im Iyer lac neat sah some chaw

Rubella

Robes Geen malo gives ise We # ck esanthoowers ses,
oreompaninllilesrconsntatinay sgrploas ae noone eomunioady
Vacei

ia chao, sf he infeutiow oecnrs im a ona: ik carly ategnaney
however, the vires cer eros Uke plaesntt es reach Ue tus in which Le
sulbecon em wluze WisUr defects. "isso defects muy be srians amc
Deiaeat ne incusle cecgesital Noare disease, ectuaet toemtcon
Ueubwess and mena setuudstigs, ‘The prevendon of lst infect,
ever. the primary puipose of stb immanizalon.

Tiomeut. Le nee for an inrermaional Nanded fox smtanbella serum foe
ase in ie aneay 2 roholiy amilxdies aud in tle control of specie
foow-rubells) Hewmneglohulns, the SAO. Peper! Cemaaite on
Ujeloyac. Swi davtioatiom stalled the second Internal Refer
Preparutou if Avt-Ruvelt Ser aut in 19715, The Reguieaats lor
Rela Vaccine (fee) are adopted by the Corrine in 197 7(01 ith
fu Ailend in THE (2, sud ase Fon Meta io us comin
ATscunpeat wih some cheeses

requirements

Tae coreinatisn of oi senses, min atkd
acbella vines. ia a 2 ern th Feu

very proposed imbicatian of the aifercal suas ef mwvaeles, num
“unt cubolla visor sliould be sudicd fn clinica Us co cenermane the
Indaitiom cfectve views desc, psn Ralanee olcuryponcnte and general
satel profs

fn the preneat Rpitoncnts, nov relereuce ia: ads ur tho: uaxiowuns
porn sumbe: of passages helen ease et ssa ond orb wed
Iisteee. itis recoctmended that asimulactivers folkew be routine
treninctr: provecire smployed prove Ube clinica! ia mei that
tslubished Ue salty and elfcasy of Die yaecine. Reference to pastnge
Teves af ry my hecome irlevaul with The we of fertteuters and 7
diteren, nuliqsitioe nf inGacion end anmbers of haves, Hor exch
iran of sitvs it x necessary Uo esT»Bish the rela jooship beeen the
lanonstoryosehravon uftines Ulan those aso ne salty wl efatcy
foe tuniane on the wlse, Wt inet vace-ces sue Ip be wen 12
caubigation wis eke sascloes, “he dosernespunse curse for exch
Sompocent what be dsioinet ry adkaisterce in the proposed
‘ombined form.

Wiesel that ecesy pronation eae che eventos ats
firm vases foe use in bums, Ose Request formule Bek
testy have beeu sesee fr detec ag alecagns agents that eight We
presenein sol zuktes no For excvie producto.

he setecaatis ns of el mn bids paint in wtosedl wolan‘es that
have eeu ssjcor smn ald systema veteran aboratary
Touitorig for the provnce a tection agents, or of eels Uesitd foan
‘Pellclar terized human diploid ol Tins, foe pred equating e
sulsates Teorey. alihivigh # gicuy soureued Fy WHO in CORES
euuclucee thal lar eo! em*e-ss, # way sullen tw eons? teas fo
extianed agents conse cet ssi fou the aeons seh agents ae
SEL spucuFtory for inividual harvests aaal?or wines Pe. i the peSEE
‘Requireinenis. On re evhsr hand, ests fur extras agents oh sal
Jabcnativy anvaely have hren arnold

Espoones Js skoway thal iis mulintsnance of a aksdand sponeeg
ppitcedre, collins andre omperatites abalone Ce Bae

edlorystrnt estate a gersisent progr Ta vee a tegui asen
Sharan ai neyaugencks

| Requirements for measles vaccine
General considerations

Hatred cf aston of posple Rass ee Yaeeivaced wilh hve ruenmacd

eles ein vaccines progucad Font a viviely 4 slvuty md ther
npls eebloree ial Use vkcemes ate tate sual elective, Pradzeven oe
wah wsocires Jeunes the onservane: of veutids sul and 338 hae
imparant th uatonal rogaremonts ‘at Liv allem! mavses
woecines soul! be avilable 12, mannfiewuess seal aliens sania
sathavi

‘Le sabe erase in people noel ith Hive eles uevine ee
Pee Tee ee ee cue notataay ng eten wus ct
‘tblisou chat ve nracnge of esate lees af arly

‘rik peoteton againar the disease. Invtuniyy fering Fe
amearlen voceins epyents te be of king dation, 25 ineetecs 3y The
perience of nemaliciye actlboior in chikitsn «evened years Seer
scene snecince prepaid “en artes atte segs Uetisee En
Ihe Latmonstan stisin clugsites ras, Aitvongh gersistae olan
to che Falmensten stesin ts basn demonsemiod. it sapoutict Ux
tudes che he mndoitker ty eetermists the dtstinn wl icaweaity
inuluced by sacezzes rived chra approvse strin

Je opvionun gee Loe the imesanzation 2 “bike knay dil fem sine
comma 9 ancy Liamznicaton is evict boy early i Hl the
myhi nov poor prowztinn, hecamss.t eves auatesil ania

mecisy¥enccie sia le beer ov erated. Ou te ter hans!
Ine peor of ingiduase of seuss oer» erloping Cael ies ch
In iteay he teeassny ty iunanive bet at eal ae a nny lg,
‘nein id yes rus mean he gence sels the vis
sien: sham? be ane The sort een omer rson tae sex! sake
litre whan mensles vawcine - adecinintess| sarly in ie cea be rally
omvcedl hg a second injection storm

dp obvipusty mpormaar tht he sans

ss mica i pues ve
reves racine #hemid shaw ag. udemy I prestuse, nevaely

sl
‘ompliations af tis repe encountered im some cases satura mes,
DPreseutexpeaience inners rv the i vaccinen fs un de dood,
fale in this yesnert. Teta abgomis a.) mone silscuaey test, the
anlracerebricoculatign ot mnogo: wsed sa craton Wt 10
Galimle ths property: Ms dawelopmen of mone naa atti i
desiuble, Tostaieasies cnecahoiepay ray he the resull of an
Jmmunopetbgeuie roti, ur tendering mechanism io aon

Fach af totion ng secti'm comally.es a veneration. The parts
sch seeton printed a uomgl type have born riven i the form cil
rosgiremerts 6 i, ia eal alviniteaian ee desires, exe raay he
sddapted av thoy staid ws deities national requirement Ibe parts of

‘ection printed iw all {ypeare comments or yesameacalations for
Jidhoee. Jivfacitale ibe inter ational csritutom of wuveae mae i
fouurdunee will: Usve Requirements, a sanmary protocol cor econtiae
the eovuls of tsi ucleded Apps

Should indivial comntice wish io nde thes Resyizeusens 66 the baie
fei nsivne!segilatinae For measles sucess, is eesouunened that
rmodilictions bo mtade ants on edition that audGed requirements
fetsure ul lesst an cual 42gros af tafty ace potency ul We vaccine, The
‘Work Tall Organon shold chen be keene ol Te action t!

Part A. Manufacturing requirements.
fc Definitions
(0.1 fafemational name and proper name

ae international age shat! he “Vaveinurn -rorbillaru visu. The
proper name shail bs the equivalent of the terri same i The
Taguage he cemnnrs of origin

Pre anear ee semision swe.

‘v2 Desoriptive dennition

~\aevinuna neuDiloiuan eum" ta propavation af fveallenuaed mules
sirup grow bua suitbic call cule. he preparation shall ty al Ue
recultements resulted ele

14 pntont_ x6 gases vaccines ero tube Bn eyo: lay 0
fe riz, “hoes sie ba ewer Gly che form. Btn os
rene naar site te ts a9 Bae ea

4.18 Intemational reference materials

and cota Pare Boe

for bie Sivaral “lin + Babe. Sa
Be Teminotogy

“Tho ltoning deities ave give Sn hp
ul.

rove Reysiteasets

Outgrat vaccine: A. voces prepared aecording 16 the maarutaess
spreitcrinne ane shove: ae adiniierstion th Funan the se and

lapse eed ta A cua ol virus dere im Fuse 4 preg, x
‘cial wee the virus spenniec as bseu presen a yee bt bs
fuse ¢ iidaum socraosiuou tw lute ealecce, Le abate seed
ors use i: the peepteston oF mucin se ts

Wiking Seo fot 8 grinning of vérae af mere sompnerion, fly
harastori, cored! fms miaserssoM kt, “se aenbng Se Tot ese
For he peveluchon of macemes,

Ceftscedc\ qazty of le staractes cells ol heman, animal rotor
origi stoned Lovecutal~# ‘Corr hows inueus umksrm eompis4in,
fue oF mere 2° wih are ged for tke posductiog of a mune?
‘oahu cell bch.

anotona sm ing ot Bak STRAY: cg oF ees a ain
nmposition drive tram eno af mare amy Tes the ell $804 a
fared fan at IMC? isto in apres, pe “Poe a sich me
wie tor prodnctine pargoses

fare" popu dove a8 taps: Selo by ther anu. ot
Bececoo. eatiee rinampaule ars pasernd or ‘oh

friction ell eae: A umber of
soul of ves aus processes belie,

ecitarey cessed fro ee sure

Sige dunes 8 qavntire a vins enspensio kaa from a Banh of
‘prntncinn ell acts that were inwaarect wy 2a Fe ston wokag sed
‘sna acersed eogothor in ¢ singe proctetion ra

nas pout A doraeenesi.s pool oF sets bar
vennel before chriiativn,

t vollotst into ane

ion? tutk: The Inawwgensorr Laie
ve oe mee lard vaws poss i Ue
‘onners avi

c2 empensive: prepared rout
roan wlict Oe lat

Pg tor al fale A coteeron of scaled inal enwtainers ot Hnbhed
‘vans thit me hemagancans anh rspert ra the ree at eontamination

cifirg. All the Fal sees msl he Foe
ve bean Siled from 3 ing: vega of final halk in nee waving essen
tn yophilizect nce: am earnest eeasltins in esa shannher
Cetee nite infetin dose 20% (CCW Tw guaulity ob a vas
suspension thats simated £9 ints 50" of ce. alee

inque-broninginP215eThescealls quantity x vimasn pendant
‘sill poctaen phe fr monslayer ee ear

CCortitication ofthe strain of virus for use in vaccine production

‘fe stsin ofcacastes virus use inthe prouaetion of seaes vaccine tal
be ideale: byhiswe-vl sevonde Catlin tno ou tue ug
he stein, ily method al ateuualion sud the paosiwe level ot whieh,
sllesation ws demronstrated by links, even.

he stain of measles us mse in the ;nnctin of yee shall hae
show ta fs ane by uppraprias laaeatay tate ace schon A oF
mont ame fed immaroganis hy test in suseopribls
comedy the nional cena sath

re
frese Ronn
Innraans. Only strains cea
shal be wed.

The kovest ieuucizing dose of sicus ia Uhe seeing that ind ous
serooomreniny in staceptise iadinidvals. shall be established. in a
nse-espuuse studs: This dose sal serve as & basis (or enable
peraueters or stability nl capay 0 Dhe wie

‘Ganoral manufacturing requirements,

(he ceyuizernts sf Cd Man acturing Vinetices few armaceatical
(Phand ielegics| 10) racuct ae Oe Reig irene fo: Human Diploid
Eells Used fr Lae Mauston a: Measles, Mucrps ond Rubella Varnes
Liver (Arena 2) eal apply ty estelishureuts wanufcum eles
Sacchi hats He Paving septa

Proxiueion anus shal he decontamninaks belie they are uy fe hes
rautitunesif eases ce,

Measles vastinw shall syns by cath Pave act andl he
intecticns miernorganieneé ee animale on the eam woriang day. The stall
shall gonsier af arrsens eho ate povioially sxamined medically amd
Fouad ts ie Neale tape shall Be fan 19 heune dha all peesuree
inv in the gignetion amas are Imig menses Prxluction soi
sonunl shall Is prgavizea ae pon scparate unite oF Ohe maulielvday
“sleblishmene with ire ependan mesanetiies,

‘Ony the vires see lot and el cuits eppsoved hy che national contol
ulority for the priditie pf eexsles vecime oll I ini
ane in eh proection ark,

Pemuns ol dine couerued with the praduetias pavcemes. other Bhan
Civil iuspevtons, shull net be penuilled to enter ke prsduclion area
‘without vid reason ie peeilic eulbrization,
at

Paucar attzotin svall Se gion ta the rocemmeendaions ie: Gad
Munubetuding. Practions 2y° Bivngical Prtuets 2) rogutis Ube
Ituiaod expericnsaatthe persons in charge proc econ aud exe
axl of use assigned mm 'canous aman of expossiblily ia he
un.facturing carairiment, wcll ay ty Cie maes‘ealo of
pordiwnT othe narcnal nme autho

Production control

erera rodustiea precau Jouuu ated in Good Maniesurie
Practices fr Uiclose “eucl lat: apply te te manera
seses vsecne

Source materin's

sea of
Thestaic ol ease ees neon 7 the peratucom ol verueasles vaeiae
sluilse ceva aeceeding w. tre speeseatncm ol section AS. The
sutchi stain skel hoapprevec Fy thsmetiimalvoncel aabosity The seed
bran five cas ane deriv From the seed Iu. sla:
ieests own i he niveneninparkowerie = mins (se eto A709
dan tayildlivens lee ease re sfc eqats mmoumsagomiecy and sey iw
Twas eines

Mowses wsras urcd the penduelign of aieales eoavine hall be
[Pragnpated a ce leulures ponies ay te raiael eouleo hori AL
Intermatixn an the source aud melloal of pavparatin of rhe est ultore
sestom ict shal be avilsble to he uateus sont eho.

eat 9 Arian-enonra os
IWasiza-cmmeya eell eziaces ae usee loz Uke poops af Measles
sive vim, tha 28 weed Bs a wsure sl gels wall se dived Thora
insecpesitie-pathnge hy se, Tis Moe sha anor
Suegalar arareseor spelpca, avin sete,
Newsnet eenss ers amt other avs pardllver vt
“nse campo virus, inet lave ch
Sskenelenis rus, Mae's lie
pe

lip sity fia tro
sir. 8,aLsticus ie lisence ins
> dat allen \iy Haven

othe igemts pathageme

Liou sgarlees 41 bis ae Bled “ver & slate fs ool ad
Seater oe te sigs oe bets tens Ihe so rags Bt
reeves bn ateoin “a Islet peagens. Sa Bre wal ee

omrugass = ter

te sewoe! Wel