Cleaning Validation in Active pharmaceutical Ingredient - APIC

26 Pages·2000·0.06 MB·English

CleaniVnagl idation
ni
lacituecamrah pevitcA
Ingredient manufacturing plants
9r9e9b1metpeS
Guide to Cleaning Validation in API plants
stnetno cf oelbaT
1. droweroF ....................................................................................................…..... 2
2. Objective ....................................................................................................…..... 3
3. Scope ..……................................................................................................…..... 4
4. seud ilsaeirtnetoP …………………………….................................................. 5
5. ecnad iyurgotalu gtenrerruC ……………….................................................... 6
6. n ogiyntciaindlaioelplaCv ........................................................................…..... 7
7. gnina esflloceveL .………….....................................................................…..... 8
8. noitad igln aisvn tafneoelmcelE ...............................................................…..... 10
8.1 .…aireti reccnatpec cftaonemhsilbatsE ................................ ................... 12
8.1.1 noitanimrete dlacim e h c ................................ ................................ ........ 12
8.1.2 noitanimrete dlacis y h p ................................ ................................ ......... 13
8.1.3 or c i m noitanimrete dlacigoloib ................................ .............................. 13
8.2 serudeco rgpninaelC ................................ ................................ ............... 13
8.3 gnilpmaS ................................ ................................ ................................ 15
8.4 .…sdohte mlacitylanA ................................ ................................ ............ 16
8.5 slocot onropitadilaV ................................ ................................ ............... 17
8.6 stro pneoritadilaV ................................ ................................ ................... 18
9. stnemeri umquemriniM ...........…..............................................................…..... 20
10. lor tengoncahC …………..........…..............................................................…..... 21
11. yrammuS ………………...........…..............................................................…..... 22
12. secnerefeR …………..…...........…..............................................................…..... 23
Guide to Cleaning Validation in API plants
1. F drowero
eettimm osCtneiderg nlIacituecamra hePvit ceA h ytdbecudo rnpe esb aehniledi usGihT
) CgInPiA.k(pruooWrg
ye htta hsttekr aem hdt nsaeinapm orcie h ytdbecneulf n eilbl iswnoitazinag rtonereffiD
toctep she trei vwya ehth atshetici l eo dhpent kaya etth atshethcaor p epenhavitres
.tcej beuhst
ta hdw nyaldip agrnigna h sctia hate r na sasii htta hdtn i nmria e obetlbaul aovs l satiI
,ero f.eer teahuTq e towdssogoarin an a5ee-ly2batpe cgc n adiseearbedis nsoacw
tnerr unscoevlesme hettad pyulsuounitn oodcte ee nhfetora wedabluo hsseinapmoc
.stnemeriu qyerrotaluger
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Guide to Cleaning Validation in API plants
2. O evitcejb
ehT noitnetni fo siht tnemucod sah neeb ot enifed a evisneherpmoc hcaorppa oteht
noitadi lfa oVsgenriundageencli oCrtlnrunaipteccii adtefeuvureingctanacmImArahP
.seitilicaf
gninaelC noitadilaV ni eht txetnoc fo evitc Alacitueca mtrnaehiPdergneIrutcafunam
:s adenife de byam
ehT ssecorp fo gnidivorp detnemucod ecnedive taht eht gninaelc sdohtem
deyolpme nihtiw a ytilicaf yltnetsisnoc slortnoc laitnetop revoyrrac fotcudorp
gnidulcni( setaidemretni dna ,)seitirupmi gninaelc stnega dna suoenartxe
.sl edveenlimre tte cdhow u ectolds trileoianphevrewbepulqe solbtaunisiretam
:snos agenriwol l eroshofetfrudec ogrnpina eeltCad i ylorataVss e tcsIein
a. ts Iia tnemeriu qreermotsuc .tcu d yoeftrhoip t rdyuntpae fesah estr u -stnie
.b ts Iia tnemeriu qyerrotaluger tcudo rtpneiderg nlIacituecamra hePvit cnAi
.erutcafunam
c. tI oslaussa se rmorf na llaoenrcrt nendatonincalipmoc tniop fo weiv eyhttilauq
fo eht.ssecorp
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Guide to Cleaning Validation in API plants
ep o.c3S
: oetvr elsl itwnemuc osDihT
1. enifeD eht cisa bstpecnoc dna sm rdeettaicos shatiw gn innoaietlaCdilaV nieht
.yrtsud ntineiderg nlIacituecamra hePvitcA
2. evreS sa a ediug morf hcihw ,snalpretsaM slocotorP dna stropeR yam eb
.delipmoc
:etoN lareneG noitadilav selpicnirp dna a yrassolg fo smret osla tnaveler otgninaelc
validation are detailed in the CEFIC / EFPIA Guide entitled ‘Good Manufacturing
secitcarP rof l .ae’ cvstiirntteeucrieAudcteacrmagrfnauIhnPaM
s e t ieI sll o’piytIprlPaenA topsu ot e thentri eoehphw. teI lPdiAe rrseeitdsner
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Guide to Cleaning Validation in API plants
4. seudis elraitnetoP
feorutcafun aem h)tlaren eng is(evlov nyirtsud ntIneiderg nlIacituecamra hePvit ceAhT
evitcA lacituecam rsathnPeidergnI yb htob lacimehc dna lacisyhp snaem hguorhta
seires fo elpitlu mp e.tssessecorp stnalP r olaudi vsiedcneiip f o,tngenmipdiuulqceni
yrallicna ,tnempiuqe yam eb desu ni tcudorp-itlum erutcafunam ro detacided ot
.stcudo rlpaudividni
ehT tluser f oeta ugq nesidenaranueidleccor psi taht yna fo a rebmun sftonanimatnoc
: shac utsnempiu qee h ntdoerutcafun ahmct atbx een h nttinese r epybam
1. tneider glnaIcituecamr aehvPi t escohrAttosrucerP
2. stcudorp-yB ro/dna noitadarged rp stcudo fo eht evitcA lacituecamrahP
tneidergnI
3. ehT suoivetrcpudorp
4. .sseco rgpnirutcafun aem hgtnir uddeyolp mselairet armeh tdo nsatnevloS
5. smsinagro-orciM
sihT s iylralucitr aepht esac ereh wlaiborc ihmtworg yam eb deniatsus ybeht
product.
6. lC stnacirbu ldn asevlesmeh tstneg agninae
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Guide to Cleaning Validation in API plants
ecnadi uygrotalug etrnerr u.C5
yrotalu gtenRer rsfulocia t retodnfemu cso idnfhootit ceecsnere f eerohrettfeR
.ecnadiuG
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Guide to Cleaning Validation in API plants
ycil onpoitadil agvninae l.C6
ebircs e od etlbl itwnemuc osdi h ftsouc onfi aemhT tnempiuqe tnempi uyqrealli c dnnaa
/ process gnina enloCitadilaV ni na e vliatcciAt utenceagimndriearrhugPtncIafunam
.tnalp ,revewoH ti si etairporppa ot trats yb gnivig a feirb noitcudortni sa ot woheht
.ytilic a nafdiehcaorp p eadbluo hnsoitadil agVninae l fCtopecnoc
sei tg inoliti rcdualt focthanfne uailn daatecmI riegtln ubIs ea ircseoaivfmvirdtaachAP
laiciffo gninaelC noitadilaV .yciloP cificepS tnemtraped seitilibisnopser dluohseb
deniltuo ni siht dna ti dluohs eb devorppa yb r.otinneemseg asniahmT ycilopdluohs
evres ot edivorp a lareneg enilediug dna noitcerid rof ynapmo c,lennosyrreoptaluger
seitirohtua dna sremotsuc sa ot woh eht ynapmoc slaed htiw saera detaicossahtiw
.noitadila VgninaelC
:stn e smge enpftiyoa wtte ostelahlrtoofp rdo lcyun coieihhlsTop
• .ct ehsa w.s vhsul f.s vesni r.e. inoitadila vgniru ddeyolpm esmre tf onoitinifeD
• A tnemetats gniyficeps tahw ynapmoc ycilop si no noitadilav fo gninaelc
.sesseco rd pn)ayrallic nganidulcn it(nempiu qodetetal esrerudecorp
• ynapmoC ycilop er noitacided fo tnempiuqe ni niatrec sesac fi( stcudorpera
demeed oot suoregnad dna / ro ylhgih evitca ot erutcafunam notcudorp-itlum
.)tnempiuqe
• .ycilo pnoitadila vlacitylanA
• ehT ycilop dluohs osla etats eht lanoitar rof eht sdohtem yb hcihwecnatpecca
.denimret e sdaiiretirc
• .ycilo pnoitadilaveR
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Guide to Cleaning Validation in API plants
gninae lfscolev e.L7
ehT eerged ro level fo gninaelc dna noitadilav deriuqer rof sessecorp ni evitcA
: nyolegr asldnep egdnirutcafun atmneiderg nlIacituecamrahP
• ) ttrononempi udqeetaci d.eed .eig( atsnuempi ueqheT
• )pe tlsan i rfeotaidemret n,iylra ee(rutcafun a fmeoga teshT
• ).c tyetilibul o,syticixo ts(tnanimatn olcaitnet oe p hfetorut aenhT
hcaE fo eht evoba eerht stellub tsum eb detaulave desab no eht txen ,tcudorpton
yt.:g ncw onetosllem eli a over esncito ybioigafelhixthnttosToatr
nI ,lareneg eht rehgih eht laitnetop rof dehsinif evitcA lacituecamrahPtneidergnI
noitanimatnoc eht retaerg eht tnemeriuqer ot etadilav gninaelc sdohtem oterusne
tcud.oyrtpefas
sre rtlunate cciyia datfeemuuvrenigca tn amecItmvAnraeah rhsePlfefviedl fogninaelc
stnemeriuqer ni seitilicaf desab no eht egats fo eht ssecorp gnieb denaelc dnaeht
ttcnuedu. oqdoreetpsrbuut sceabfunam
e e lsl fp e bywomnt1anoaaa Ta hxrenpaetgoms aou7pclli yam edi cneo delhetveflo
.st onleewt egbninaelc
gdnni anl aetfeeevaohtlehtacltrts nr oeomrteudtc ayf tufeinohlatimbis nto Ipsesihetr
ne oldibn taan aiolufa tiua it ddsseieu tvsjdnhaiaeo cudbmsaqnrieei odnfaorietpadilav
.lanoita rcifitneics
gninaelC dluohs eb deirrac tuo sa noos sa lacitcarp retfa eht dne fo gnissecorpdna
.e stux ern onfoitidn oeclbati u nastina lep hetva edlluohs
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Guide to Cleaning Validation in API plants
Table 1 : levels of cleaning
LEVEL DESUNEHW GNINAELC
DE RNIOUIQTEARDILAV
LE2VEL .e.i
• tcud orrePvoegnahcfo laitness e–sey
lani fn ides utnempiuqe
step
• esfneootaidemretnI
fpoe tlsan i ofhtctab
another
LE1VEL .e.i
• lan i rfsoetaidemretnI lev enleewt enboissergorp
Step of one product to ngonidnep ed2 dn0a
rehto nfeaotaidemretni s s eedrcnuoatfraopn
ndoes atbnanimatnoc
• ylraE petSot lanoita rcifitneics
an isetaidemretni
product sequence
LE0VEL ohtct a,bngiapmac- n.ie.i deriuq enroitadil aovn
revoegn ahhcctab
YLLAUDI V D ISETDET SNSA :UISU EBMELLBNCALOVAREP
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