kelompok 3_kelas a_validation of pharmaceutical industry general

7/25/2019 Kelompok 3_kelas A_validation of Pharmaceutical Industry General

http://slidepdf.com/reader/full/kelompok-3kelas-avalidation-of-pharmaceutical-industry-general 1/26

KELAS AKELOMPOK 31. FITRI (1211012003)

2. DIDI M IKHSAN (1211012004)3. RIRI ADE KURNIA ( 1211012005)4. ARIEF CHANDRA ABBAS(1211012006)

5. LEFRINA GUSRIANI (1211012007)

ALIDATION OF

PHARMACEUTICALINDUSTR! IN GENERAL



ALIDATION

"#$%"&$' $ %'*+,-&-% -$%-*-&/"& '$%- " /$/ %--- '"+"*- &/"& " -*$* '*- $##

*'$&-&# '%+*- " '%+*& ,--&$$& -%-&-,$-% -*$*"&$' "%+"#$& "&&$8+&-

(FDA91:;7)



CONCEPT OF VALIDATION

GMP<%-$&$' $ &/- "#$%"&$' '=-&"8#$/$ %'*+,-&-% -$%-*-

&/"& -&"8#$/- " /$/ %--- 'certainty &/"& " "&$*+#" '*-$## *'$&-&# " '%+*& &/"&

'$%- &/- -$'+# -&"8#$/-%-*$*"&$' "% +"#$& "&&$8+&-"- ""$#"8#-



IMPORTANCE OF VALIDATION

1. A+"*- ' +"#$&

2. T$,- 8'+%3. P'*- '&$,$"&$'

4. R-%+*&$' ' +"#$& *'&.

5. N',$"# ,$><+9 "% 8'&&#- -*?

6. M$$,"# 8"&*/ "$#+-9 $,'-% -@*$-&# "% '%+*&$$&.

7. R-%+*&$' $ --*&$'.

;. I*-"-% '+&+&.:. A'$%"*- ' *"$&"# ->-%$&+-

10. F-- *',#"$& "8'+& '*- -#"&-% "$#+-.

11. R-%+*-% &-&$ $ '*- "% $ $/-% ''%.

12. M'- "$% "% -#$"8#- &"&<+ ' - -+$,-&

13. E"$- *"#-<+ ', %--#',-& '?.

14. E"$- ,"$&-"*- ' -+$,-&.

15. I,'-% -,#'-- ""-- ' '*--.

16. M'- "$% "+&',"&$'.

17. G'-,-& -+#"&$' (C',#$"*- $&/ "#$%"&$' -+$-,-& $ -*-"' '8&"$$ "'"# &' ,"+"*&+- "% &' $&'%+*- - '%+*&)

(N"%/"?+,"92012)



A'$"&- "% *',#-&- %'*+,-&"&$' $ -*'$-% "*+*$"# ' &/- "#$%"&$'. S&"%"% O-"&$ P'*-%+-(SOP)9 '%+*&$' ',+#"9 %-&"$#-% %'*+,-&"&$' 8"&*/

*/"-C'&'#9 ->-$,-&"# -'&$ &-,9 ""#&$*"#%'*+,-&9 -'& %--#',-&9 "#$%"&$' '&'*'# "%-'& "- " $&-"# "& ' "#$%"&$' /$#''/. T/-"#$%"&$' ' &/- %'*+,-&"&$' '$%- " '+*- '$',"&$' ' &/- ''$ '-"&$' ' &/- #"& "% $ "

-'+*- &/"& $ +-% $ &/- +8-+-& '*- '%--#',-& ' ,'%$*"&$' "*&$$&$-.

A## &-& "*&$$&$- $## &"?- " #--# ' $,"*& "-,-& &'-+- &/"& &-,9 -$*- "%P'%+*& -- %-&-,$-%

%$-*&# "-*&-% 8 &/- &-&.

A -"#$%"&$' '", /'+#% 8- $,#-,-&-% ' "-,"-& -+$,-& ' &/- -"#$%"&$' -+$-,-& "%*/"- *'&'#.



PROCESS ALIDATION

P'*- "#$%"&$' $ %--% " &/-*'##-*&$' "% -"#+"&$' ' %"&"9 ', &/-'*- %-$ &"- &/'+/ *',,-*$"#

'%+*&$'9 /$*/ -&"8#$/- *$-&$*-$%-*- &/"& " '*- $ *""8#- '*'$&-&# %-#$-$ +"#$& '%+*&.P'*- "#$%"&$' $'#- " -$- '

"*&$$&$- &"?$ #"*- '- &/- #$-**#- '&/- '%+*& "% '*-.

(FDA9 2011)



PLANNING FOR VALIDATION

A## "#$%"&$' "*&$$&$- /'+#% 8- #"-%.

S/'+#% 8- *#-"# %--% "% %'*+,-&-% $ "#$%"&$' ,"&- #" (MP)' -+$"#-& %'*+,-&.

T/- MP /'+#% 8- " +,," %'*+,-&9 /$*/ $ 8$-9 *'*$- "%*#-".

T/- MP /'+#% *'&"$ %"&" ' "& #-"& &/- '##'$

1. "#$%"&$' '#$*.2. O"$"&$'"# &+*&+- ' "#$%"&$' "*&$$&$-.

3. S+,," ' "*$#$&$-9 &-,9 -+$,-& "% '*-- &' 8-"#$%"&-%.

4. D'*+,-&"&$' ',"& T/- ',"& &' 8- +-% ' '&'*'# "% -'&.

5. P#"$ "% */-%+#$.6. C/"- *'&'#.

7. R---*- &' ->$&$ %'*+,-&.

;. I*"- ' #"- '-*&9 $& ," 8- -*-" &' *-"&- -""&-"#$%"&$' ,"&- #".

(N"%/"?+,"92012)



TYPES OF VALIDATION

Prospective valiationE&"8#$/$ %'*+,-&-% -$%-*- &/"& " %-$*- '*-' &-, &' %' /"& &/- %'9 ' " -<#"-% -$- '*$-&$* $-&$"&$' $&/$ &/- ,-"$ ' "#$%"&$'

-& 8"-%P#".

Conc!rrent valiationI +-% /- " ->$&$ '*- *" 8- /' &' 8- $ "&"&- ' *'&'# 8 +- ' &-& ' ",#- &"?- "&

&"&-$* '$& $ " '*-9 "% "& &/- -% ' &/- '*-.A## %"&" "- *'##-*&-% $,+#&"-'+# $&/ &/-$,#-,-&"&$' ' &/- '*-9 &' %-,'&"&- +@*$-&$',"&$' &' '*- -'%+*$8$#$&.



Retrospective ValiationE&"8#$/$ %'*+,-&-% -$%-*- &/"& " '*- %'- '&/"&$& +'& &' %'9 8"-% ' -$- "% ""#$ ' /$&'$*"# %"&".

Desi"n #!ali$cation %D#& T/- $&-& ' &/- D $ $ &/- #"$ "% *',,$$'$'*- ,-& $&/ " +,8- ' ,-*/"$,9 $*#+%$

< G--"&$' ' U- R-+$-,-& S-*$*"&$'

< -$*"&$' ' &/$ &- *'-'%$ +- -+$-,-&-*$*"&$'.< S+#$- E"#+"&$' A+%$&< C/-*? &/- C/"##-- ' &/- %-$ 8 GMP "+%$&< P'%+*& +"#$& I,"*&A-,-&< S-*$$ "#$%"&$' %'*+,-&"&$' -+$-,-& ' +#$-< A--,-& $&/ &/- +#$- "8'+& &/- -',"*- &"-&< F"*&' A**-&"*- T-& (FAT)9 S$&- A**-&"*- T-& (SAT) "%*',,$$'$ '*-%+-< D-$&$' ' *'&+*&$' "% $&"##"&$' %'*+,-&"&$') &'"$& $&/ I&"##"&$' +"#$*"&$' (I.



Installation #!ali$cation %I#&I $ " '' &/"& &/- -+$,-& ' &-, /" 8--%'*+,-&-% $ %--#'-%%-#$--% "% $&"##-% $

"**'%"*- $&/ %-$ %"$9 -%' -*',,-%"&$'"% $</'+- -+$-,-&. M'-'-9 I9 &/"& " -*'% ' &/-,"$ -"&+- ' &/- -+$,-& ' &-, $ $&"##-%9 /'""$#"8#- "% -+- &/"& &/- "- +'&-% 8 +@*$-& "%"'$"&- %'*+,-&"&$' &' $,#-,-& "&$"*&'

'-"&$'9 ,"$&-"*- "% *'&'# ' */"-.Operational #!ali$cation %O#&O $ %'*+,-&-% '' &/"& '-"&- &/- "*$#$&" '$%-%$ &/- "8'- %-$9 '-"&$' ' "'-% "**-&"*- "-' -+$,-&9 " "#$*"8#-. I *"- /-- '*- &- "-

*'$%--% " "'$"&- #"*-8' 8"&*/ $ +-% &'%-,'&"&- %-$*- +*&$'"#$&.A## - %-$*- /'+#% 8- +## &"?- $&' -$*- 8-'- &/-&"& ' O &' -+- &/"& "& #-"& 8- +- &' +- &/- %-$*-9*',#-&- $&/ "## ,-*/"$*"# "-,8# "% -<+"#$*"&$'*/-*? "- &/"& &/- %-$*- $ +## +*&$'"# "%&/"&D'*+,-&"&$' $ *',#-&-.



Per'or(ance #!ali$cation %P#& T/- '"# ' P $ %'*+,-&-% '' &/"& &/--+$,-& *" "#" 8- "*/$--% /$#- '%+*$&/- -*$*"&$' ' " #'- -$'% "& " %--%'-"&$ '$&9 " '%+*& ' &/- -*$-% +"#$&. T/--*$*"&$' $## ,"?- ---*- &' '*-"",-&-9 $<'*- "% '%+*& -*$*"&$'. P

-+$- &/-- '%+*& 8"&*/- ""$#"8#- ' "##"**-&"*-C$&-$" ' $<'*- "% '%+*& &-&$.F' +# P -+$- &/- 8--& ' ,-%$+, &'+### "## &/- %"&" '- " #'- -$'% ' ",#$.

T/- P %'*+,-&"&$' /'+#% 8- ' &"%"%,"+"*&+$ '*-%+- "% 8"&*/ -*'% "%%-*$8- &/- ,-&/'%'#' ' ",#$ "% &-&$ &'8-.



PROCESS ALIDATION ACTIITIES IN THREE STAGES

• S&"- 1 P'*- D-$ T/- *',,-*$"#,"+"*&+$ '*- $ %--% %+$ &/$ &"-8"-% ' ?'#-%- "$-% &/'+/ %--#',-& "%*"#-<+ "*&$$&$-.

• S&"- 2 P'*- +"#$*"&$' D+$ &/$ &"-9 &/-'*- %-$ $ -"#+"&-% &' %-&-,$- $ &/- '*-$ *""8#- ' -'%+*$8#- *',,-*$"# ,"+"*&+$.

• S&"- 3 C'&$+-% P'*- -$*"&$' O'$

"+"*- $ "$-% %+$ '+&$- '%+*&$' &/"& &/-'*- -,"$ $ " &"&- ' *'&'#.

• (FDA9 2011)



STAGE 1 PROCESS DESIGN

P'*- %-$ $ &/- "*&$$& ' %-$ &/-*',,-*$"# ,"+"*&+$ '*- &/"& $## 8---*&-% $ #"-% ,"&- '%+*&$' "% *'&'#-*'%. T/- '"# ' &/$ &"- $ &' %-$ "

'*- +$&"8#- ' '+&$- *',,-*$"#,"+"*&+$ &/"& *" *'$&-&# %-#$- "'%+*& &/"& ,--& $& +"#$& "&&$8+&-.

1. B+$#%$ "% C"&+$ P'*- ?'#-%- "%

+%-&"%$

2. E&"8#$/$ " S&"&- ' P'*- C'&'#

(FDA9 2011)



1. BUILDING AND CAPTURING PROCESS KNOJLEDGEAND UNDERSTANDING

G--"##9 -"# '*- %-$ ->-$,-& %' '& --% &'8- -',-% +%- &/- CGMP *'%$&$' -+$-% ' %+$&-%-% ' *',,-*$"# %$&$8+&$' &/"& "- ,"+"*&+-%%+$ S&"- 2 ('*- +"#$*"&$') "% S&"- 3

(*'&$+-% '*- -$*"&$'). T/- /'+#%9 /'--9 8-*'%+*&-% $ "**'%"*- $&/ '+% *$-&$* ,-&/'% "%$*$#-9 $*#+%$ ''% %'*+,-&"&$' "*&$*-. T/$-*',,-%"&$' $ *'$&-& $&/ ICH 10 P/","*-+&$*"#+"#$& S&-,. 12 D-*$$' "% +&$*"&$' ' &/-

*'&'# /'+#% 8- +@*$-&# %'*+,-&-% "% $&-"##-$--% &' -$ "% --- &/-$ "#+- ' +- '"%"&"&$' #"&- $ &/- #$-**#- ' &/- '*- "% '%+*&

(FDA9 2011)



2. ESTABLISHING A STRATEG! FOR PROCESS CONTROL

P'*- ?'#-%- "% +%-&"%$ $ &/- 8"$ '-&"8#$/$ " "'"*/ &' '*- *'&'# ' -"*/ +$&'-"&$' "% &/- '*- '-"##. S&"&-$- ' '*-*'&'# *" 8- %-$-% &' -%+*- $+& "$"&$'9 "%+& '$+& "$"&$' %+$ ,"+"*&+$ ("% ' -%+*- $&$,"*& ' &/- '+&+&)9 ' *',8$- 8'&/ "'"*/-.

P'*- *'&'# "%%- "$"8$#$& &' "+- +"#$& ' &/-'%+*&. C'&'# *" *'$& ' ,"&-$"# ""#$ "%

-+$,-& ,'$&'$ "& $$*"& '*-$ '$& (211.110(*)). D-*$$' -"%$ &/- &- "% ->&-& ''*- *'&'# *" 8- "$%-% 8 -"#$- $? "-,-&9&/- -/"*-% "% $,'-% " '*- ->-$-*- $ "$-%

(FDA9 2011)


http://slidepdf.com/reader/full/kelompok-3kelas-avalidation-of-pharmaceutical-industry-general 16/26(N"%/"?+,"92012



STAGE 2 PROCESS UALIFICATION

D+$ &/- '*- +"#$*"&$' (P) &"- ' '*-"#$%"&$'9 &/- '*- %-$ $ -"#+"&-% &' %-&-,$- $ $&

$ *""8#- ' -'%+*$8#- *',,-*$"# ,"+"*&+-. T/$&"- /" &' -#-,-&

(1) %-$ ' &/- "*$#$& "% +"#$*"&$' ' &/- -+$,-& "%+&$#$&$-

(2) '*- -',"*- +"#$*"&$' (PP).

D+$ S&"- 29 CGMP<*',#$"& '*-%+- ,+& 8-

'##'-%. S+**-+# *',#-&$' ' S&"- 2 $ -*-"

8-'- *',,-*$"# %$&$8+&$'. 15 P'%+*& ,"+"*&+-%%+$ &/$ &"-9 $ "**-&"8#-9 *" 8- -#-"-% '%$&$8+&$'

(FDA9 2011)



1. DESIGN OF THE FACILIT! AND UALIFICATION OF THE EUIPMENT AND UTILITIES

P'- %-$ ' " ,"+"*&+$ "*$#$& $-+$-% +%- "& 2119 +8"& C9 ' &/- CGMP-+#"&$' ' B+$#%$ "% F"*$#$&$-. I& $--&$"# &/"& "*&$$&$- -',-% &' "+-'- "*$#$& %-$ "% *',,$$'$-*-%- PP. H--9 &/- &-, +"#$*"&$'--&' "*&$$&$- +%-&"?- &' %-,'&"&- &/"&+&$#$&$- "% -+$,-& "- +$&"8#- ' &/-$$&-%-% +- "% -', '-#. T/--"*&$$&$- -*-"$# -*-%- ,"+"*&+$'%+*& "& &/- *',,-*$"# *"#-

(FDA9 2011)



+"#$*"&$' ' +&$#$&$- "% -+$,-& --"## $*#+%-&/- '##'$ "*&$$&$-

S-#-*&$ +&$#$&$- "% -+$,-& *'&+*&$' ,"&-$"#9

'-"&$ $*$#-9 "% -',"*- */""*&-$&$* 8"-%' /-&/- &/- "- "'$"&- ' &/-$ -*$* +-.

-$$ &/"& +&$#$& &-, "% -+$,-& "- 8+$#& "%$&"##-% $ *',#$"*- $&/ &/- %-$ -*$*"&$' (-..9

8+$#& " %-$-% $&/ '- ,"&-$"#9 *""*$&9 "%

+*&$'9 "% '-# *'-*&-% "% *"#$8"&-%). -$$ &/"& +&$#$& &-, "% -+$,-& '-"&- $

"**'%"*- $&/ &/- '*- -+$-,-& $ "## "&$*$"&-%'-"&$ "-. T/$ /'+#% $*#+%- */"##-$ &/-

-+$,-& ' &-, +*&$' /$#- +%- #'"% *',""8#-&' &/"& ->-*&-% %+$ '+&$- '%+*&$'. I& /'+#% "#'

$*#+%- &/- -',"*- ' $&--&$'9 &'"-9 "%&"&<+ " $ ->-*&-% %+$ '+&$- '%+*&$'. O-"&$"- /'+#% 8- /' *""8#- ' 8-$ /-#% " #' "'+#% 8- -*-" %+$ '+&$- '%+*&$'



2. PROCESS PERFORMANCE UALIFICATION

T/- '*- -',"*- +"#$*"&$' (PP) $&/- -*'% -#-,-& ' S&"- 29 '*-+"#$*"&$'. T/- PP *',8$- &/- "*&+"#"*$#$&9 +&$#$&$-9 -+$,-& (-"*/ ' +"#$-%)9"% &/- &"$-% -'-# $&/ &/- *',,-*$"#

,"+"*&+$ '*-9 *'&'# '*-%+-9 "%*','-& &' '%+*- *',,-*$"# 8"&*/-. A+**-+# PP $## *', &/- '*- %-$"% %-,'&"&- &/"& &/- *',,-*$"#,"+"*&+$ '*- -', " ->-*&-%.

(FDA9 2011)



STAGE 3 CONTINUED PROCESS ERIFICATION

T/- '"# ' &/- &/$% "#$%"&$' &"- $ *'&$+"#

"+"*- &/"& &/- '*- -,"$ $ " &"&- ' *'&'#(&/- "#$%"&-% &"&-) %+$ *',,-*$"# ,"+"*&+-. A&-, ' &-, ' %-&-*&$ +#"-% %-"&+-

', &/- '*- " %-$-% $ --&$"# &' "**',#$/&/$ '"#. A%/--*- &' &/- CGMP -+$-,-&9-*$*"##9 &/- *'##-*&$' "% -"#+"&$' ' $',"&$'"% %"&" "8'+& &/- -',"*- ' &/- '*-9 $##"##' %-&-*&$' ' +%-$-% '*- "$"8$#$&.

E"#+"&$ &/- -',"*- ' &/- '*- $%-&$-'8#-, "% %-&-,$- /-&/- "*&$' ,+& 8- &"?-&' *'-*&9 "&$*$"&-9 "% --& '8#-, ' &/"& &/-'*#- -,"$ $ *'&'#

(FDA9 2011)



RE<ALIDATION

R-+$-% /- &/-- $ " */"- $ " ' &/- *$&$*"# '*- "",-&-9

',+#"&$'9 $," "*?"$ *','-&9 " ,"&-$"# "8$*"&'9 ,"'-+$,-& ' -,$-. F"$#+- &' ,--& '%+*& "% '*- -*$*"&$' $

8"&*/- '+#% "#' -+$- '*- -<"#$%"&$'.

R-<"#$%"&$' 8-*',- -*-" $ *-&"$ $&+"&$'. T/- '##'$ "- ->",#-' ',- ' &/- #"-% ' +#"-% */"- &/"& ," -+$- -<"#$%"&$'

C/"- $ " ,"&-$"# (/$*"# '-&$- +*/ " %-$&9 $*'$&9 "&$*#-

$- %$&$8+&$'9 "% ,'$&+-9 -&*.9 &/"& ," "-*& &/- '*- ' '%+*&). C/"- $ &/- '+*- ' "*&$- " ,"&-$"# ,"+"*&+-.

C/"- $ "*?"$ ,"&-$"# ($," *'&"$-*#'+- &-,).

C/"- $ &/- '*- (-..9 ,$>$ &$,-9 %$ &-,-"&+- "% 8"&*/ $-).

C/"- $ &/- -+$,-& (-.. "%%$&$' ' "+&',"&$* %-&-*&$' &-,).

C/"- ' -+$,-& /$*/ $'#- &/- -#"*-,-& ' -+$,-& ' " #$?- '

#$?- 8"$ '+#% '& ',"## -+$- " -"#$%"&$' ->*-& &/"& &/$ --+$,-& C/"- $ &/- #"&"*$#$&.

"$"&$' --"#-% 8 &-% ""#$ (-.. '*- %$&).

A#",9 2012.



)ASIC CONCEPT OF PROCESS VALIDATION

C"#$8"&$'9 -$*"&$' "% ,"$&-"*- ' '*--+$,-&.

P-+"#$*"&$' ' -"#$%"&$'.

E&"8#$/$ -*$*"&$' "% -',"*-*/""*&-$&$*.

S-#-*&$' ' ,-&/'%9 '*- "% -+$,-& &'-+- &/- '%+*& ,--& -*$*"&$'.

+"#$*"&$' ' "#$%"&$' ' '*- "% -+$,-&.

T-&$ &/- "# '%+*&9 +$ "#$%"&-% ""#&$*"#,-&/'%9 $ '%- &' ,--& -*$*"&$'.

C/"##-$9 "+%$&$9 ,'$&'$ ' ",#$ &/--*'$-% *$&$*"# ?- &- ' &/- '*-.



CALIBRATION

T/- -& ' '-"&$' &/"& "&"8#$/9 +%--*$-% *'%$&$'9 &/- -#"&$'/$ 8-&--"#+- $%$*"&-% 8 " $&+,-& ' &-, ',-"+$ (' ->",#-9 -$/&9 &-,-"&+-"% H) -*'%$9 "% *'&'##$9 ' &/- "#+----&-% 8 " ,"&-$"# ,-"+-9 "% &/-*'-'%$ ?' "#+- ' " ---*-&"%"%. L$,$& ' "**-&"*- ' &/- -+#& '

,-"+$ /'+#% 8- -&"8$#$/-%. A#"-,-,8- " ---*- &"%"% $ "#" +-%$ *"#$8"&$'.



DOCUMENTATION

D'*+,-&"&$' "& -"*/ &"- ' &/- '*- "#$%"&$' #$-**#- $ --&$"#' --*&$- *',,+$*"&$' $ *',#->9 #-&/9 "% ,+#&$%$*$#$"'-*&. D'*+,-&"&$' $ $,'&"& ' &/"& ?'#-%- "$-% "8'+& "'%+*& "% '*- $ "**-$8#- "% *',-/-$8#- &' '&/- $'#-% $-"*/ &"- ' &/- #$-**#-. I',"&$' &""-* "% "**-$8$#$& "-+%",-&"# &--& ' &/- *$-&$* ,-&/'%. T/- "- "#' --&$"# &'

-"8#$ '"$"&$'"# +$& -'$8#- "% "**'+&"8#- ' &/- '*- &',"?- $',-%9 *$-*-<8"-% %-*$$' &/"& +#&$,"&-# +'& &/- -#-"-' " '%+*& &' *',,-*-.

T/- %--- "% &- ' %'*+,-&"&$' -+$-% 8 CGMP " %+$ &/-"#$%"&$' #$-**#-. D'*+,-&"&$' -+$-,-& "- -"&-& %+$ S&"- 29'*- +"#$*"&$'9 "% S&"- 39 *'&$+-% '*- -$*"&$'. S&+%$-

%+$ &/-- &"- ,+& *'', &' CGMP "% ,+& 8- "'-% 8 &/-+"#$& +$& $ "**'%"*- $&/ &/- -+#"&$' (-- 211.22 "% 211.100).$"# "% $,+$& *#-""*- &+%$-9 -- /- -',-% "& ,"## *"#-9"#' -+$- +"#$& +$& '-$/&

(FDA9 2011)



REFERECES

A#",9 S/'"$8 M%. P/","*-+&$*"# P'*- "#$%"&$' A

O-$-. '+"# ' A%"*-% P/","* E%+*"&$' R--"*/. O*&<D-* 2012 '# 2 I+- 4. "- 1:5

FDA9 C+-& G''% M"+"*&+$ P"*&$*- (CGMP) R-$$'1 9 20119 P'*- "#$%"&$' G--"# P$*$#- "% P"*&$*-

FDA +$%-#$- ' G--"# P$*$#- ' P'*- "#$%"&$'

(M" 1:;7)

N"%/"?+,"9 L. et al. A '-$- ' /","*-+&$*"#"#$%"&$' +"#$& "+"*- $- '$&. $&-"&$'"#

'+"# ' --"*/ $ /","* "% */-,$&. IRPC 20119

1(4)

kelompok 3_kelas a_validation of pharmaceutical industry general

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