Cosmetics GMP

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GOOD MANUF ACTURING PRACTICES FOR COSMETIC PRODUC TS (GMP) - QMS Requirements K&S Qu!it" Ass#$ites $n ssist #r%niti#ns t't re seein% t# e$#me $erti*e+ t# IS O,, ./ 0,11 K&S Qu ! it " As s# $i tes $ n 2r#3 i+ e % 2 n ! "s is 42re- ssessments5 in tern ! u +i t ser3 i$ e5 #n-s it e tr i ni n% 5 2r #$ e+ ure 6r it in %5 im2!ementti#n4$# nsu!tin% n+ #t'er ser3i$es ISO ,,./0,11 C# nsumers re e$#min % m#re n + m#re $#n$erne+ #u t t' e s 7et" #7  t'e $#smeti$ 2r #+u$ ts t'e" r e usin %8 Fers #7 !!e r%i es n+ +er mtit is $us e+ " tinte+ #r 2#is#ne+ $#smeti$s '3e een e3er-2resent in re$ent "ers8 Certin in%re+ients use+ in $#smeti$s su$' s 7r%rn$es n+ 2reser3ti3es5 $n tri%%er n !!er %i$ re $ti# n8 O3i# us!" 5 t 'es e in%r e+ie nts 2!" 2i3# t! r#! e in t 'e $#smeti$ 2r#+u$ts #7 #ur $'#i$e n+ $#rre$t +#sin% #7 t'ese sustn$es t'ere7#re is #7 e" im2#rtn$e t# 3#i+ irritti#n #7 t'e sin t'r#u%' #3er-e92#sure8 E9m2!es #7 #3er- e92#sure t# 2reser3ti3es '3e 7requent!" een #ser3e+ in se3er! 'ist#ri$ $ses5 #ne e9m2!e ein% eut" $re ms t't $#ntine+ mer$ur"8 :eut" $re ms #$$ si#n !!" 6er e re2#rte + t# $#nt in e9$ess m#unts #7 mer$ur"5 6it' 2#is#ne+ $#nsumers e9'iitin% $!er t#9i$ neur#!#%i$ ! s"m2t#ms8 In$i+ents su$' s t'ese '3e !6"s im2$te+ t'e 2u!i$ n+ t'ere7#re '3e 7#r$e+ re%u! t#rs t# te $ti #n t# ensure $#nsumer s 7et"8 E9m2!es #7 t'ese re t'e requirements mnu 7$tu rer s '3e t# +'er e t# in ter ms #7 2re -+e*n e+ n+ 22r #3e+ 2r# +u$t s2e$i *$ ti# ns n+ " 2utti n% s"s temti $ %ui+ n$e in 2! $e #n '#6 t# #r %n ise mn u7 $tu rin % n+ +i str iu ti# n su2 2!" $' ins8 T'e re$en t %r #6t ' #7 e9t en+ e+ n+ $#m2!e 9 %! #! su22 !" $'ins #$$urri n% in $#minti#n 6i t' t'e ! $ #7  2r#2er $#ntr#! n+ #3ersi%'t '3e m+e $#n$erns #3er qu!it" n+ s7et" e3en m#re seri#us8 Mnu7$turers n+ reti!ers re ur%e+ t# ++ress +e*$ien$ies in t'ei r su22 !" $'i ns5 n+ se3er ! qu ! it " st n+r+ s '3e e en 2r #2#s e+ t# +e!i3er ssistn$e in ensurin% %!#! $#smeti$ 2r#+u$ts s7et"8 T'e intr#+u$ti#n #7 ISO ,,./ mrs m;#r ste2 in t'e re!isti#n #7 %!#!!" re$#%nise+ stn+r+ 7#r $#smeti$ 2r#+u$ts s7et"8 G<O:A< COSMETIC PRODUCTS SAFET=  T'e $#ntent #7 ISO ,,./0,11 Gui+e!i nes #n G##+ Mnu7$turin % Pr$ti$es 7#r C#smeti$ Pr #+u$ ts 's een 22r #3e+ n+ $$e 2te+ " num er #7 re% u!t# r" #+ies r#un+ t'e 6#r!+8 F#r e9m2!e t'e Internti#n! C##2erti#n #n C#smeti$ Re%u !ti#n (ICCR) > ;#int e?#rt " t'e USA5 t'e Eur#2en Uni#n5 @2n n+ Cn+ > %ree+ in t'eir @u!" ,11 meetin% t# im2!ement ISO ,,./ in t'eir res2e$ti3e re%i#ns5 6'ere3er 2#ssi!e8 Re%u!t#rs #7 se3er! #7 t'ese ICCR re%i#ns '3e +e$i+e+ t# $t $$#r+in%!"8 In t'e USA5 it 6s 2r#2#se+ t't t'e F##+ & Dru% A+ministrti#n (FDA) m#+i7" its $urrent %ui+n$e8 (S#me #7 t'ese requirements re

Transcript of Cosmetics GMP

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GOOD MANUFACTURING PRACTICES FOR COSMETIC PRODUCTS (GMP) - QMS

Requirements

K&S Qu!it" Ass#$ites $n ssist #r%niti#ns t't re seein% t# e$#me $erti*e+

t# ISO,,./0,11 K&S Qu!it" Ass#$ites $n 2r#3i+e %2 n!"sis42re-

ssessments5 intern! u+it ser3i$e5 #n-site trinin%5 2r#$e+ure 6ritin%5im2!ementti#n4$#nsu!tin% n+ #t'er ser3i$es

ISO ,,./0,11

C#nsumers re e$#min% m#re n+ m#re $#n$erne+ #ut t'e s7et" #7 

t'e $#smeti$ 2r#+u$ts t'e" re usin%8 Fers #7 !!er%ies n+ +ermtitis $use+

" tinte+ #r 2#is#ne+ $#smeti$s '3e een e3er-2resent in re$ent "ers8 Certin

in%re+ients use+ in $#smeti$s su$' s 7r%rn$es n+ 2reser3ti3es5 $n tri%%er n

!!er%i$ re$ti#n8 O3i#us!"5 t'ese in%re+ients 2!" 2i3#t! r#!e in t'e $#smeti$

2r#+u$ts #7 #ur $'#i$e n+ $#rre$t +#sin% #7 t'ese sustn$es t'ere7#re is #7 e"

im2#rtn$e t# 3#i+ irritti#n #7 t'e sin t'r#u%' #3er-e92#sure8 E9m2!es #7 #3er-e92#sure t# 2reser3ti3es '3e 7requent!" een #ser3e+ in se3er! 'ist#ri$ $ses5

#ne e9m2!e ein% eut" $rems t't $#ntine+ mer$ur"8 :eut"

$rems #$$si#n!!" 6ere re2#rte+ t# $#ntin e9$ess m#unts #7 mer$ur"5 6it'

2#is#ne+ $#nsumers e9'iitin% $!er t#9i$ neur#!#%i$! s"m2t#ms8 In$i+ents su$' s

t'ese '3e !6"s im2$te+ t'e 2u!i$ n+ t'ere7#re '3e 7#r$e+ re%u!t#rs t# te

$ti#n t# ensure $#nsumer s7et"8 E9m2!es #7 t'ese re t'e requirements

mnu7$turers '3e t# +'ere t# in terms #7 2re-+e*ne+ n+ 22r#3e+ 2r#+u$t

s2e$i*$ti#ns n+ " 2uttin% s"stemti$ %ui+n$e in 2!$e #n '#6 t# #r%nise

mnu7$turin% n+ +istriuti#n su22!" $'ins8 T'e re$ent %r#6t' #7 e9ten+e+

n+ $#m2!e9 %!#! su22!" $'ins #$$urrin% in $#minti#n 6it' t'e !$ #7 

2r#2er $#ntr#! n+ #3ersi%'t '3e m+e $#n$erns #3er qu!it" n+ s7et"e3en m#re seri#us8 Mnu7$turers n+ reti!ers re ur%e+ t# ++ress +e*$ien$ies in

t'eir su22!" $'ins5 n+ se3er! qu!it" stn+r+s '3e een 2r#2#se+ t#

+e!i3er ssistn$e in ensurin% %!#! $#smeti$ 2r#+u$ts s7et"8 T'e intr#+u$ti#n #7 

ISO ,,./ mrs m;#r ste2 in t'e re!isti#n #7 %!#!!" re$#%nise+ stn+r+

7#r $#smeti$ 2r#+u$ts s7et"8

G<O:A< COSMETIC PRODUCTS SAFET=

 T'e $#ntent #7 ISO ,,./0,11 Gui+e!ines #n G##+ Mnu7$turin% Pr$ti$es 7#r

C#smeti$ Pr#+u$ts 's een 22r#3e+ n+ $$e2te+ " numer #7 re%u!t#r"#+ies r#un+ t'e 6#r!+8 F#r e9m2!e t'e Internti#n! C##2erti#n #n C#smeti$

Re%u!ti#n (ICCR) > ;#int e?#rt " t'e USA5 t'e Eur#2en Uni#n5 @2n n+ Cn+

> %ree+ in t'eir @u!" ,11 meetin% t# im2!ement ISO ,,./ in t'eir

res2e$ti3e re%i#ns5 6'ere3er 2#ssi!e8 Re%u!t#rs #7 se3er! #7 t'ese ICCR re%i#ns

'3e +e$i+e+ t# $t $$#r+in%!"8 In t'e USA5 it 6s 2r#2#se+ t't t'e F##+ & Dru%

A+ministrti#n (FDA) m#+i7" its $urrent %ui+n$e8 (S#me #7 t'ese requirements re

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si+ t# e$#me mn+it#r" in ,1.B)

ISO ,,./ +e!s 6it' !! s2e$ts #7 t'e su22!" $'in #7 $#smeti$ 2r#+u$ts57r#m t'e

er!" +e!i3er" #7 r6 mteri!s n+ $#m2#nents unti! t'e s'i2ment #7 t'e *n!

2r#+u$t t# t'e $#nsumer8 T'e %ui+e!ines su22#rt t'#se #r%nisti#ns t't 6is' t#

7#!!#6 t'e 2r$ti$! +3i$es t# mn%e t'eir 'umn5 te$'ni$!5 n+ +ministrti3e

se$ti#ns t't re ?e$tin% 2r#+u$t qu!it"8 G##+ Mnu7$turin% Pr$ti$es 7#!!#6 t'e2rin$i2!es #7 s#un+ s$ienti*$ ;u+%ement n+ ris ssessment t# 2r#+u$e 2r#+u$ts

t't meet +e*ne+ $'r$teristi$s8

:r#+ S$#2e 7#r ISO ,,./

ISO ,,./ %i3es %ui+e!ines 7#r t'e 2r#+u$ti#n5 $#ntr#!5 st#r%e n+ s'i2ment #7 

$#smeti$ 2r#+u$ts8 T'ese %ui+e!ines $#3er t'e qu!it" n+ s7et" s2e$ts #7 t'e

2r#+u$t8 In t'is 6" mnu7$turers #7 $#smeti$ *n! 2r#+u$ts re ?e$te+5 s re

t'e su22!iers #7 $#smeti$ in%re+ients8 In ++iti#n5 t'e stn+r+ is re!e3nt 7#r

reti!ers5 rn+ '#!+ers n+ 6'#!es!ers #7 $#smeti$ 2r#+u$ts8 Furt'erm#re5its2e$i*es %ener! requirements 7#r qu!it" mn%ement s"stems " in$#r2#rtin%

ris ssessment se+ 22r#$' t# +e*ne $riti$! n+ n#n-$riti$! e!ements

ensurin% 'i%' qu!it" su22!" $'in #2erti#ns8

K&S Qu!it" Ass#$ites $n 'e!2 "#ur #r%niti#n t# e$#me ISO ,,./ $erti*e+

6it' ser3i$es !ie 2r#$e+ure 6ritin%5 intern! u+it#r trinin%5 #n-site trinin%5 %2

n!"sis5 $#nsu!tin% n+ #t'er ser3i$es8

 T'e C#smeti$s Qu!it" Mn%ement S"stem n+ Or%nisti#n

In $#smeti$s GMP qu!it" mn%ement #r%nisti#n5 t'e em2'sis is #n

est!is'in% n+ mintinin% qu!i*e+ 2ers#nne! se t't is 6e!! trine+ n+

$2!e #7 $#nsistent!" 2r#+u$in% s7e 2r#+u$ts8 A s#un+ n#6!e+%e se #7 t'e

2ers#nne! in $#smeti$s mnu7$turin% #r%nisti#n is #7 t'e utm#st im2#rtn$e

n+ t'is re is re$ei3in% seri#us ttenti#n in qu!it" %ui+n$e8 An#t'er $ru$i!

e!ement is $!er +es$ri2ti#n #7 tss n+ !ines #7 res2#nsii!ities #7 !! 2ers#nne! in

t'e #r%nisti#n8Furt'erm#re5 settin% u2 e?e$ti3e intern! n+ e9tern!

$#mmuni$ti#n $'nne!s 's t# e t'e t#2 2ri#rit" #7 mn%ement t# ensure t'e

2rti$i2ti#n n+ $#mmitment #7 2ers#nne! t !! !e3e!s #7 t'e #r%nisti#n8 A!!

t'ese n+ #t'er s2e$ts #7 t'e qu!it" #r%nisti#n nee+ t# e est!is'e+ in 7#rm!

6ritin% > $#ntr#!!e+ +#$umentti#n s"stem is t'ere7#re n intrinsi$ 2rt#7 #r%nisti#ns 6#rin% un+er ISO ,,./

it' t'e 'e!2 #7 qu!i*e+ QMS 2r#7essi#n!s in #ur #r%niti#n5 6e re !e t# ui!+

n+ 2ut int# 2r$ti$e Qu!it" Mn%ement S"stem t't 7$t#rs in !! t'e s2e$ts #7 

"#ur #r%niti#n8 =#u $n e ssure+ #7 t'e ISO ,,./ $erti*$ti#n 7ter re$ei3in%

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#ur $#m2re'ensi3e ser3i$es8 K & S Qu!it" Ass#$ites 6i!! 6#r #ut 3i!e

22r#$' t't is est suite+ 7#r "#ur #r%niti#n t# 7un$ti#n in t'e m#st 2r#+u$ti3e

n+ e?e$ti3e mnner8