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2-4 ICH Overview
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7/21/2019 2-4 ICH Overview
http://slidepdf.com/reader/full/2-4-ich-overview 1/41
Satish Mallya January 20-22, 20101 |
2-4 ICH Quality Guidances:an overview
PQP Assessment Training
January 18-21, 212
Satish Mallya
January 18-21, 2012
7/21/2019 2-4 ICH Overview
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Satish Mallya January 20-22, 20102 |
ICH T!"ics
#ta$ility - Q1A % Q1&
Analytical 'alidati!n % Q2
Im"urities % Q(A - Q(C )Q(* % c!nce"t "a"er+
Parmac!"!eias % Q4A - Q4 )and anne.es+
Quality !/ i!tecn!l!gical Pr!ducts % Q0A % Q0
#"eci/icati!ns % QA % Q
G!!d 3anu/acturing Practice % Q
Parmaceutical *e5el!"ment % Q8
Quality 6is7 3anagement - Q
Parmaceutical Quality #ystem % Q1
*e5el!"ment and 3anu/acturing !/ *rug #u$stances % Q11
January 18-21, 2012
7/21/2019 2-4 ICH Overview
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Satish Mallya January 20-22, 20103 |
&!cus
Stability - Q1A, B, C, D, E & F
Validation of Analytical Methods – Q2!1"
#$%'ities – Q(A, B & C
S%ecifications – Q)A Che$ical Sbstances" & Q)B& Q)B
Biotechnolo*y+Biolo*ical 'odcts"Biotechnolo*y+Biolo*ical 'odcts"
January 18-21, 2012
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Satish Mallya January 20-22, 20104 |
#ta$ility
Q1A)62+ Stability estin* of .e/ D'* Sbstances and'odcts
Q1 hotostability estin* of .e/ D'* Sbstances and'odcts
Q1C Stability estin* fo' .e/ Dosa*e Fo'$s
Q1*B'ac0etin* and Mat'iin* Desi*ns fo' Stability estin*of .e/ D'* Sbstances and 'odcts
Q1 Ealation of Stability Data
Q1& Stability Data ac0a*e fo' !e*ist'ation A%%lications inCli$atic 3ones ### & #V 9itdra9n % June 2"
January 18-21, 2012
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Satish Mallya January 20-22, 20105 |
Q1A!2"SAB#4#5 ES#.6 7F
.E8 D!96 S9BSA.CES A.D !7D9CS
*rug #u$stance *rug Pr!duct#tress testing P!t!sta$ility testing
#electi!n !/ $atces #electi!n !/ $atces
C!ntainer cl!sure system C!ntainer cl!sure system
#"eci/icati!n #"eci/icati!n
Testing /reuency Testing /reuency
#t!rage c!nditi!ns #t!rage c!nditi!ns
#ta$ility c!mmitment #ta$ility c!mmitment
5aluati!n 5aluati!n
#tatements;<a$eling #tatements;<a$eling
January 18-21, 2012
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Satish Mallya January 20-22, 20106 |
#tress Testing;P!t!sta$ility
*rug #u$stance *rug Pr!duct
7ne %'i$a'y batch
Effect of te$%e'at'es in 1:;Cinc'e$ents e<*<, =:;C, ):;C,etc<" aboe that fo' accele'atedtestin*"
Effect of h$idity e<*<, >
?=@!"
7ne %'i$a'y batch
As in #C Q1B
January 18-21, 2012
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Satish Mallya January 20-22, 20107 |
#electi!n !/ atces
*rug #u$stance *rug Pr!duct
*ata !n at least tree "rimary $atces !/minimum "il!t scale manu/actured $y te samesyntetic r!ute as used /!r "r!ducti!n $atces=
*ata !n at least tree "rimary $atces !/ tedrug "r!duct % t9! "il!t and tird !ne can $esmaller - same /!rmulati!n and "ac7aged in tesame c!ntainer cl!sure system as "r!"!sed/!r mar7eting=
Te manu/acturing "r!cess used /!r "rimary$atces s!uld simulate tat t! $e a""lied t!"r!ducti!n $atces
>ere "!ssi$le, use di//erent $atces !/ tedrug su$stance=
#!uld $e "er/!rmed !n eac indi5idualstrengt and c!ntainer si?e !/ te drug "r!ductunless $rac7eting !r matri.ing is a""lied=
January 18-21, 2012
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C!ntainer Cl!sure #ystem
*rug #u$stance *rug Pr!duct
Stdies to be condcted on the A# %ac0a*ed in a containe'
clos'e syste$ that is identical too' si$lates the %'o%osedco$$e'cial %ac0a*in*
Stdies to be ca''ied ot incontaine' clos'e syste$ identical
to co$$e'cial %ac0a*in* stdiesca''ied ot in othe' %ac0a*in*$ate'ials can be sed ass%%o'tin* info'$ation
January 18-21, 2012
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#"eci/icati!n
*rug #u$stance *rug Pr!duct #tudies t! include attri$utes
susce"ti$le t! cange duringst!rage and 9ic can in/luenceuality, sa/ety and e//icacy:- Pysical
- Cemical- 3icr!$i!l!gical
#tudies t! include attri$utessusce"ti$le t! cange duringst!rage and 9ic can in/luenceuality, sa/ety and e//icacy:- Pysical
- cemical,- micr!$i!l!gical,- "reser5ati5e c!ntent- /uncti!nality tests )e=g= 9it
deli5ery systems+
'alidated analytical met!ds t! $eem"l!yed
'alidated analytical met!ds t! $eem"l!yed
June 21January 18-21, 2012
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Satish Mallya January 20-22, 201010 |
Testing &reuency
*rug #u$stance *rug Pr!duct
&!r API 9it "r!"!sed re-test "eri!d;sel/-li/e!/ at least 12 m!nts: 5ery ( m!nts !5er/irst year, e5ery m!nts !5er ne.t 12 m!ntsand annually terea/ter=
&!r &PP 9it "r!"!sed re-test "eri!d;sel/-li/e!/ at least 12 m!nts: 5ery ( m!nts !5er/irst year, e5ery m!nts !5er ne.t 12 m!ntsand annually terea/ter=
Accelerated c!nditi!n: 3inimum !/ ( time"!ints, including initial and /inal time "!ints)e=g= , ( @ m!nts+
Accelerated c!nditi!n: 3inimum !/ ( time"!ints, including initial and /inal time "!ints)e=g= , ( @ m!nts+
Intermediate c!nditi!n )due t! signi/icantcange under accelerated c!nditi!n+: studydesign s!uld include 4 time "!ints )e=g= , ,
and 12 m!nts
Intermediate c!nditi!n )due t! signi/icantcange under accelerated c!nditi!n+: studydesign s!uld include 4 time "!ints )e=g= , ,
and 12 m!nts+
3atri.ing !r rac7eting may $e a""lied
June 21January 18-21, 2012
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Satish Mallya January 20-22, 201011 |
#t!rage C!nditi!ns
6ene'al Case *rug #u$stance *rug Pr!duct
#tudy #t!rage
C!nditi!ns
3inimum
"eri!d
c!5ered $y
data at
su$missi!n
#tudy #t!rage
C!nditi!ns
3inimum
"eri!d
c!5ered $y
data at
su$missi!n
<!ng term 20 C⁰ 2 C; B⁰
0B6H !r
( C⁰ 2 C ;0B⁰
0B6H
12 m!nts <!ng term 20 C⁰ 2 C ;B⁰
0B6H !r
( C⁰ 2 C ;0B⁰
0B6H
12 m!nts
Intermediate ( C⁰ 2 C ;0B⁰
0B6H
m!nts Intermediate ( C⁰ 2 C ;0B⁰
0B6H
m!nts
Accelerated 4 C⁰ 2 C ;0B⁰
0B6H
m!nts Accelerated 4 C⁰ 2 C ;0B⁰
0B6H
m!nts
June 21January 18-21, 2012
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Satish Mallya January 20-22, 201013 |
#t!rage C!nditi!ns
Sto'a*e in f'eee'
Sto'a*e belo/ - 2: C Case by case basis⁰
*rug #u$stance *rug Pr!duct
#tudy #t!rage
C!nditi!ns
3inimum
"eri!d c!5ered
$y data atsu$missi!n
#tudy #t!rage
C!nditi!ns
3inimum
"eri!d c!5ered
$y data atsu$missi!n
<!ng
term
- 2 C⁰ 0 C⁰ 12m!nts <!ng
term
- 2 C⁰ 0 C⁰ 12m!nts
June 21January 18-21, 2012
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Satish Mallya January 20-22, 201014 |
#t!rage C!nditi!ns % *rug Pr!duct
Se$i-%e'$eable containe's Stdy Sto'a*e Conditions Mini$$ %e'iod
coe'ed by data at
sb$ission
<!ng term 20 C⁰
2 C;4B⁰
0B 6H !r ( C⁰ 2 C;(0B⁰ 0B 6H 12 m!nts
Intermediate ( C⁰ 2 C;0B⁰ 0B 6H m!nts
Accelerated 4 C⁰ 2 C;⁰ 3T 20B 6H m!nts
June 21January 18-21, 2012
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Satish Mallya January 20-22, 201015 |
#igni/icant Cange
*rug #u$stance *rug Pr!duct*e/ined as /ailure t! meets"eci/icati!ns
-D0B cange in assay /r!m te initialresults
-Any degradati!n "r!duct e.ceedingits acce"tance criteri!n
-&ailure t! meet acce"tance criteria/!r a""earance, "ysical attri$utesand /uncti!nality tests
-&ailure t! meet acce"tance criteria/!r "H
-&ailure t! meet acce"tance criteria/!r diss!luti!n !/ 12 d!sage units
January 18-21, 2012
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Satish Mallya January 20-22, 201016 |
5aluati!n
*rug #u$stance *rug Pr!duct
#tatistical analysis n!t necessary i/data e.i$its little !r n! degradati!nand 5aria$ility
#tatistical analysis n!t necessary i/data e.i$its little !r n! degradati!nand 5aria$ility
<imited e.tra"!lati!n !/ real time data
"ermitted 9it Eusti/icati!n
<imited e.tra"!lati!n !/ real time data
"ermitted 9it Eusti/icati!n
June 21January 18-21, 2012
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Satish Mallya January 20-22, 201017 |
Q1B 77SAB#4#5 ES#.6 7F
E8 D!96 S9BSA.CES A.D !7D9CS
'oides 2 o%tions fo' so'ces of li*ht – arti/icial dayligt /lu!rescent lam" c!m$ining 5isi$le and ultra5i!let
)F'+ !ut"uts, .en!n, !r metal alide lam" – sam"le s!uld $e e."!sed t! $!t te c!!l 9ite /lu!rescent and near
ultra5i!let lam"
est on A# fi'st – if not %hotosensitie then no f'the' testin* is'ei'ed
#f A# is %hotosensitie then testin* to be contined on asa%%'o%'iate" – Tests !n te e."!sed drug "r!duct !utside !/ te immediate "ac7 – Tests !n te drug "r!duct in te immediate "ac7
– Tests !n te drug "r!duct in te mar7eting "ac7
8he'e a%%'o%'iate, i$%act of li*ht d'in* $anfact'in*
January 18-21, 2012
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Satish Mallya January 20-22, 201018 |
Q1C
Anne. t! Q1A )62+
Additional *idance on line etensions
!edced 'ei'e$ents at ti$e of filin* ) $onths
accele'ated and ) $onths lon* te'$
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Satish Mallya January 20-22, 201019 |
Q1* - rac7eting
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Satish Mallya January 20-22, 201020 |
Q1* - 3atri.ing
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Satish Mallya January 20-22, 201021 |
Q1* - 3atri.ing
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Satish Mallya January 20-22, 201022 |
Q1
EVA49A#7. 7F SAB#4#5 DAA
'oides 'eco$$endations fo' at !, !ef'i*e'ated andF'eee' sto'a*es"
– t'eatin* stability data
– Etendin* 'e-test %e'iod o' shelf-life beyond %e'iod coe'ed by
lon*-te'$ data
– Statistical a%%'oaches to analysis of stability data
'o*'ession
– Sta't /ith data nde' accele'ated condition
– hen assess data nde' inte'$ediate condition, if a%%'o%'iate – Finally ealate t'ends and a'iability of the lon*-te'$ data
January 18-21, 2012
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Satish Mallya January 20-22, 201023 |
utc!mes
When there is no significant change under accelerated conditions (RT)Long-term and accelerated data showinglittle or no change over time and little orno variability
6etest "eri!d !r sel/ li/e can $e u" t!t9ice, $ut 3T 12 m!nts $ey!nd te"eri!d c!5ered $y l!ng-term data
Long-term or accelerated data showingchange over time and/or variability
*ata n!t amena$le t! statistical analysis,$ut rele5ant su""!rting data "r!5ided:6etest "eri!d !r sel/ li/e can $e u" t!1=0 times, $ut 3T m!nts $ey!nd te"eri!d c!5ered $y l!ng-term data
I/ a statistical analysis is "er/!rmed:6etest "eri!d !r sel/ li/e !/ u" t! t9ice,$ut n!t m!re tan 12 m!nts $ey!nd te
"eri!d c!5ered $y l!ng-term data
January 18-21, 2012
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Satish Mallya January 20-22, 201024 |
utc!mes
When there is significant change under accelerated conditions(RT) but no significant change at intermediate condition
*ata n!t amena$le t! statistical analysis
6etest "eri!d !r sel/ li/e can $e u" t! ( m!nts $ey!nd te "eri!d c!5ered
$y l!ng-term data i/ $ac7ed $y rele5ant d!cumentati!n
I/ statistical analysis is "er/!rmed
6etest "eri!d !r sel/ li/e can $e u" t! 1=0 times, $ut 3T m!nts $ey!nd
te "eri!d c!5ered $y l!ng-term data 9en $ac7ed $y statistical analysis
and rele5ant su""!rting data
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Satish Mallya January 20-22, 201025 |
Q2)61+VA4#DA#7. 7F A.A45#CA4 !7CED9!ES
*e/ines 5alidati!n caracteristics: – Accuracy – Precisi!n
• Repeatability• nter!e"iate #re$isi%n
– #"eci/icity – *etecti!n <imit
– Quantitati!n <imit – <inearity – 6ange
6!$ustness t! $e c!nsidered at a""r!"riate stage !/ de5el!"ment !/ teanalytical met!d
#ystem suita$ility test "arameters t! $e esta$lised /!r a "articular"r!cedure de"ending !n te ty"e !/ "r!cedure $eing 5alidated -Parmac!"!eias t! $e c!nsulted /!r additi!nal in/!rmati!n
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Satish Mallya January 20-22, 201026 |
'A<I*ATI CHA6ACT6I#TIC#
'alidati!ncaracteristics
I* Im"urities
Quant= limit
Assay
Accuracy
Precisi!n
6e"eati$ility
Int=Precisi!n
#"eci/icity
<*
<Q
<inearity
6ange
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
January 18-21, 2012
Q(
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Satish Mallya January 20-22, 201027 |
Q(
#$%'ities
#$%'ities in .e/ D'* Sbstances Q3A(R2): Defines thresholdsfor reporting, identification and qualification of impurities in DS
#$%'ities in .e/ D'* 'odcts Q3(R2): Defines thresholds for
reporting, identification and qualification of impurities in D
6ideline fo' !esidal Solents Q3! !=" Classifies 'esidal
solents by 'is0 assess$ent
– Class 1 s!l5ents: s!l5ents t! $e a5!ided
– Class 2 s!l5ents: s!l5ents t! $e limited
– Class ( s!l5ents: s!l5ents 9it l!9 t!.ic "!tential
6ideline fo' Metal #$%'ities Q3D (!oncept paper " #ul$ 2%%&)
January 18-21, 2012
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Satish Mallya January 20-22, 201028 |
Q(A!2"C4ASS#F#CA#7. 7F #M9!##ES
7'*anic #$%'ities – #tarting materials – y-"r!ducts – Intermediates – *egradati!n "r!ducts – 6eagents, ligands, catalysts
#no'*anic #$%'ities – 6eagents, ligands, catalysts – Hea5y metals !r !ter residual metals – In!rganic salts – ter materials )e=g=, /ilter aids, carc!al+
!esidal Solents
January 18-21, 2012
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Satish Mallya January 20-22, 201029 |
Q(A)62+Definitions
Quali/icati!n Te "r!cess !/ acuiring and e5aluating data tatesta$lises te $i!l!gical sa/ety !/ an indi5idual im"urity !r a gi5enim"urity "r!/ile at te le5el)s+ s"eci/ied=
6e"!rting Tres!ld: A limit a$!5e )D+ 9ic an im"urity s!uld $ere"!rted<
#"eci/ied Im"urity An im"urity tat is indi5idually listed and limited 9it a
s"eci/ic acce"tance criteri!n in te ne9 drug su$stance s"eci/icati!n= As"eci/ied im"urity can $e eiter identi/ied !r unidenti/ied=
Fnidenti/ied Im"urity An im"urity /!r 9ic a structural caracterisati!nas n!t $een acie5ed and tat is de/ined s!lely $y ualitati5e analytical"r!"erties )e=g=, cr!mat!gra"ic retenti!n time+
Fns"eci/ied im"urity An im"urity tat is limited $y a general acce"tancecriteri!n, $ut n!t indi5idually listed 9it its !9n s"eci/ic acce"tancecriteri!n, in te ne9 drug su$stance s"eci/icati!n
January 18-21, 2012
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Satish Mallya January 20-22, 201030 |
Q(A)62+
January 18-21, 2012
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Satish Mallya January 20-22, 201031 |
Q(A)62+
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Satish Mallya January 20-22, 201032 |
Q()62+
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Satish Mallya January 20-22, 201033 |
Q()62+
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Satish Mallya January 20-22, 201034 |
Q(C)60+
Pr!5ides 2 !"ti!ns /!r descri$ing limits !/ Class 2 #!l5ents
'ption : As %e' the table %'oided - calclated sin* D# of 1: * andthe calclation - – C!ncentrati!n )""m+ 1 . Permitted *aily ."!sure )P*+; *!se
– P* is gi5en in terms !/ mg;day and d!se is gi5en in g;day=
f *D is more than % g use option 2
#!l5ent P* )mg;day+ C!ncentrati!nlimit )""m+
Acet!nitrile
Cl!r!$en?ene
4=1
(=
41
(
January 18-21, 2012
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Satish Mallya January 20-22, 201035 |
.am"le /!r "ti!n 2
!"tion # It is n!t c!nsidered necessary /!r eac c!m"!nent !/ te drug "r!duct t!c!m"ly 9it te limits gi5en in "ti!n 1= Te P* in terms !/ mg;day can $e used9it te 7n!9n ma.imum daily d!se and euati!n )$oncentration (""m) % &''' *+/ *ose+ t! determine te c!ncentrati!n !/ residual s!l5ent all!9ed in drug"r!duct
.am"le: P* !/ acet!nitrile is 4=1mg;day
$om"onent ,mount in formulation ,cetonitrile content *aily
e"osure
*rug su$stance =( g 8 ""m =24 mg
.ci"ient 1 = g 4 ""m =( mg
.ci"ient 2 (=8 g 8 ""m (=4 mg
*rug Pr!duct 0= g 28 ""m (=4 mg The sum of the amounts of solvent "er day should be less than that given by the
*+
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Satish Mallya January 20-22, 201036 |
QA
Add'esses as%ects sch as
– Peri!dic !r s7i" testing
– 6elease 5s sel/-li/e criteria
– In-"r!cess tests
– *esign and de5el!"ment c!nsiderati!ns
– <imited data a5aila$le at /iling – Parametric release
– Alternati5e "r!cedures
– Parmac!"!eial tests and acce"tance criteria
– 5!l5ing tecn!l!gies
– Im"act !/ drug su$stance !n drug "r!duct s"eci/icati!ns – 6e/erence standard
January 18-21, 2012
QA
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Satish Mallya January 20-22, 201037 |
QA
*ecisi!n Trees
1 % sta$lising acce"tance criteria /!r s"eci/ied im"urity In *# 2 % sta$lising acce"tance criteria /!r degradati!n "r!duct in *P
( % sta$lising acce"tance criteria /!r P#* in *#
4 % In5estigating need t! set acce"tance criteria /!r "!lym!r"ism in *#and *P
0 % sta$lising I*, Assay and enanti!meric im"urity "r!cedures /!rciral *# and ciral *# in *P
% 3icr!$i!l!gical Quality Attri$utes !/ *# and .ci"ients
% #etting acce"tance criteria /!r *P diss!luti!n
8 % 3icr!$i!l!gical Quality Attri$utes !/ n!n sterile *P
January 18-21, 2012
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Satish Mallya January 20-22, 201038 |
Peri!dic !r #7i" Testing
Shold be stified<
May be a%%lied to ce'tain tests only e<*< 'esidal
solents and $ic'obiolo*ical test fo' solid o'al %'odcts"
!eco$$end that it shold be a%%lied %ost a%%'oal
Batch to batch 'etestin* to be 'esto'ed in the eent of
fail'e
January 18-21, 2012
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Satish Mallya January 20-22, 201039 |
Desi*n and Deelo%$ent Conside'ations
#t $ay be %ossible to %'o%ose ecldin* o' 'e%lacin*ce'tain tests based on e%e'ience and data acc$lated
– micr!$i!l!gical testing /!r drug su$stances and s!lid
d!sage /!rms 9ic a5e $een s!9n during de5el!"ment
n!t t! su""!rt micr!$ial 5ia$ility !r gr!9t )*ecisi!n Trees
and 8+ – e.tracta$les /r!m "r!duct c!ntainers 9ere it as $een
re"r!duci$ly s!9n tat eiter n! e.tracta$les are /!und in
te drug "r!duct !r te le5els meet acce"ted standards /!r
sa/ety
January 18-21 2012January 18-21, 2012
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Satish Mallya January 20-22, 201040 |
Desi*n and Deelo%$ent Conside'ations
– "article si?e testing may $e "er/!rmed as an in-"r!cesstest, !r may $e "er/!rmed as a release test, de"ending !n
its rele5ance t! "r!duct "er/!rmance
– diss!luti!n testing /!r immediate release s!lid !ral drug
"r!ducts made /r!m igly 9ater s!lu$le drug su$stances
may $e re"laced $y disintegrati!n testing, i/ tese"r!ducts a5e $een dem!nstrated during de5el!"ment t!
a5e c!nsistently ra"id drug release caracteristics
)*ecisi!n Tree + )!nly acce"ted in e.ce"ti!nal
circumstances and all c!nditi!ns must $e met including
su$stantial de5el!"ment data+
January 18-21, 2012
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