MAKALAH PRAKTEK KERJA PROFESI APOTEKER APOTEKER PROGRAM STUDI PROFESI APOTEKER APOTEKER FAKULT FAKULTAS AS FARMASI UNIVERSITAS UNIV ERSITAS GADJAH MADA BIDANG INDUSTRI Di PT. BOROBUDUR INDUSTRI JAMU PERIODE April – Mei 201
Di!"!"# Ole$% H&"#i#& K"'&l& S&ri( S.F&r' R&/i &/i$ A# A#&r K"!" K"!"' '&#i#/i& i&!( S.F S.F&r'
1)*+,)--*FA*1020 1)*+,)--*FA*1020 1)*+,)1-*FA*101-,
FAKULTAS FARMASI UNIVERSITAS GADJAH MADA 3OG3AKARTA 201 VALIDASI
A. Defi Defini nissi
V&li4&!i &4&l&$ /i#4&5&# pe'6"5/i&# 4e#&# 7&r& &# !e!"&i 6&$8& /i&p 6&$&#( pr9!e4"r( 5ei&/&#( !i!/e'( perle#5&p&#( &/&" 'e5&#i!'e &# 4i"#&5&# 4&l&' 4&l&' pr94"5 pr94"5!i !i 4&# pe#&8 pe#&8&!&# &!&# &# &# &5&# &5&# !e#&#/ !e#&#/i&! i&!&& 'e#7&p 'e#7&p&i &i $&!il $&!il &# &# 4ii#i#5&# 4ii#i#5&#.. Veri:i5&!i ri:i5&!i &4&l&$ 59#:i'&!i 4e#&# 4e#&# 7&r& pe#";i&# pe#";i&# 4&# pe#&;i&# pe#&;i&# 6"5/i 6&$8& per!&r&/&# &# 69le$ 4ie/&p5&# /erpe#"$i.
&li4&!i &4& + &i/" % 1. Me#"li Me#"li!5& !5&# # &p& &p& &# &# $&r" $&r"!! 4il&5" 4il&5"5&# 5&# 2. Mel&5" Mel&5"5&# 5&# &p& &# &# /el&$ /el&$ 4i/"li 4i/"li!! +. Me#"li Me#"li!5& !5&# # &p& &# &# /el&$ /el&$ 4il&5 4il&5"5& "5&#. #. T";"&# >&li4&!i &4&l&$ "#/"5 'e'6eri5&# 5ep&!/i&# 6&$8& &l&/ 6er:"#!i !e!"&i 4e#&# &# 4ii#i#5&#( &i/" % 1. H&r" H&r"!! &4 &4& pr9 pr9/& /&p p 2. H&r" H&r"!! 4i7&/ i7&/&/ &/ +. H&r" H&r"!! &4& &4& pr9 pr9r& r&' ' ). Die>&l" &l"&!i
B. Alas Alasan an Va Valida lidasi si
V&li4&!i V&li4&!i 4&l&' i#4"!/ri :&r'&!i 4il&5"5&# "#/"5% 1. Me'e#"$i Me'e#"$i per&/"r&# per&/"r&# pe'eri#/&$ pe'eri#/&$ <4&l&' pe#er&p&# pe#er&p&# ?POB=. ?POB=. 2. Me#; Me#;&' &'i# i# '"/" '"/" 96&/ 4e#&# 4e#&# 7&r& 7&r& pe#e pe#er& r&p&# p&# !"&/" !"&/" pr9! pr9!e! e! &# &# !"4& !"4&$ $ 4ip&$&'i 4i!er/&i pe#&8&!&# '"/" &# 'e'&4&i 'e&5i#5&# 5i/& &5&# '"/" pr94"5 &# 4i$&!il5&#
C. Tujuan juan Valid Validasi asi
T";"&# 4il&5"5&##& >&li4&!i 4&l&' i#4"!/ri :&r'&!i &4&l&$ "#/"5 'e#$&!il5&# !e4i&&# :&r'&!i &# !e7&r& 59#!i!/e# /er;&'i# '"/"#&( /er'&!"5 5e&'&#&# 4&# e:e5/i:i/&!#&
D. Tipe Validasi
V&li4&!i /er4iri 4&ri + '&7&'( &#/&r& l&i#% 1. V&li4&!i Pr9!pe5/i: V&li4&!i &# 4il&5"5&# !e6el"' pel&5!&#&&# !"&/" pr9!e4"r( pe'6"&/&# :9r'"l& 6&r" &/&" per&l&/&# 6&r". U'"'#& 4i"#&5&# + batch "#/"5 5ei&/&# >&li4&!i pr9!pe5/i:. V&li4&!i i#i 'er"p&5&# /&$&p 4&ri pe#e'6&#&# 'e#";" pr94"5!i &li4&!i pr9!pe5/i: &4&l&$ >&li4&!i pr9!e! pr94"5!i 5&ple/ 6&r". 2. V&li4&!i Re/r9!pe5/i: V&li4&!i i#i 'elip"/i pe#7&/&/&# &ri&6el>&ri&6el 4&# !er&i&# l&$ &# /el&$ 4il&5"5&# 4&ri 5e!el"r"$&# pr9!e! pr94"5!i
pr94"5
&5$ir=.
V&li4&!i
i#i
6er"#&
!e6&&i
6"5/i*495"'e#/&!i 6&$8& pr9!e! &# 4il&5"5&# !"4&$ /er59#/r9l !e!"&i 4e#&# SOP &# /el&$ 4i6"&/ &li4&!i pr9!e4"r &# /el&$ 4il&5!&#&5&#. ?9#/9$ >&li4&!i re/r9!pe5/i: &4&l&$ >&li4&!i pr9!e! pr94"5!i 5&p!"l &# /el&$ 4ip&!&r5&#. +. V&li4&!i K9#5"re# V&li4&!i i#i 'e#7&5"p pe#&8&!&# pr9!e! 4&ri l&$l&$ pr9!e! &# 4i&#&p 5ri/i! <7ri/i7&l pr97e!!i# !/ep= 4&# 'eli6&/5&# pe#";i&# pr94"5 4&ri /i&p l&$ pr9!e! "#/"5 'e'&!/i5&# 6&$8& pr94"5 &# 4i$&!il5&# 4&l&' !e/i&p pr9!e! &li4&!i 59#5"re# &4&l&$ >&li4&!i pr9!e! pr94"5!i 5&p!"l &# !e4&# 6er;&l&#
E. Parameter Validasi
Pr9!e4"r &#&li!i! &# $&r"! 4i>&li4&!i 'elip"/i 6e6er&p& ;e#i! pe#";i&#( &i/" &4&#& pe#9/9r( ";i li'i/ "#/"5 'e#e#4&li5&# 5e6er&4&&# pe#9/9r( !er/& ";i 5"&#/i/&/i: 59'p9#e# &5/i: &/&" 59'p9#e# l&i# 4&l&' pr94"5 96&/ 96&/&#. Pe'ili$&# p&r&'e/er &# &5&# 4i";i /er&#/"# 4&ri ;e#i! 4&# 'e/94e pe#";i&# &# &5&# 4i>&li4&!i er= &#&li/ &# 4i/&'6&$5&#. Ke7er'&/&# $&!il &#&li!i! !&#&/ /er&#/"# 5ep&4& !e6&r&# &l&/ !i!/e'&/i5 4i 4&l&' 5e!el"r"$&# /&$&p&# &#&li!i!
( A − B ) x
× 100
Accuracy 4&p&/ 4i/e#/"5&# 'el&l"i 4"& 7&r&( &i/" 'e/94e !i'"l&!i er= &/&" 'e/94e pe#&'6&$&# 6&5"
5e'"4i&#
4i&#&li!i!
4e#&#
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&#
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4i>&li4&!i i4"&l( 4i"5"r 'el&l"i pe#e6&r&# $&!il i#4i>i4"&l 4&ri r&/& r&/& ;i5& pr9!e4"r 4i/er&p5&# !e7&r& 6er"l&# p&4& !&'pel!&'pel &# 4i&'6il 4&ri 7&'p"r&# &# $9'9e#. Pre!i!i 4i"5"r !e6&&i !i'p&#&# 6&5" &/&" !i'p&#&# 6&5" rel&/i: <59e:i!ie# >&ri&!i=. Precision 4&p&/ 4i#&/&5&# !e6&&i repeatability <5e/er"l&#&#= &/&" reproducibility <5e/er/ir"&#=. Repeatability &4&l&$ 5e!e5!&'&&# 'e/94e ;i5& 4il&5"5&#
6er"l&# 5&li 9le$ &#&li! &# !&'& p&4& 59#4i!i !&'& 4&# 4&l&' i#/er>&l 8&5/" &# pe#4e5. Repeatability 4i#il&i 'el&l"i pel&5!&#&&# pe#e/&p&# /erpi!&$ le#5&p /er$&4&p !&'pel!&'pel i4e#/i5 &# /erpi!&$ 4&ri batch &# !&'&( ;&4i 'e'6eri5&# "5"r&# 5e!e5!&'&&# p&4& 59#4i!i &# #9r'&l i&!i. Nil&i r&/&&# 59#!e#/r&!i $&r"! 6er&4& 4&l&' re#/&# upper limit 4&# lower limit. R"'"! 6&/&! 5e#4&li( &i/"% x ± 3 σ Batas kendali = √ n
Reproducibility &4&l&$ 5e!e5!&'&&# 'e/94e ;i5& 4i5er;&5&# p&4& 59#4i!i &# 6er6e4&. Bi&!&#& &#&li!i! 4il&5"5&# 4&l&' l&69r&/9ri"' l&69r&/9ri"' &# 6er6e4& 'e#"#&5&# per&l&/&#( pere&5!i( pel&r"/( 4&# &#&li! &# ;"& 6er6e4&. A#&li!i! 4il&5"5&# /er$&4&p !&'pel!&'pel &# 4i4"& i4e#/i5 &# 4i sampling 4&ri batch &# !&'&. Kri/eri& !e5!&'& 4i6eri5&# ;i5& 'e/94e 'e'6eri5&# !i'p&#&# 6&5" rel&/i: &ri&!i
p&4& 5i!&r&# 59#!e#/r&!i /er/e#/". Re#/&# 'e/94e &4&l&$
per#&/&&# 6&/&! /ere#4&$ 4&# /er/i#i &#&li/ &# !"4&$ 4i/"#;"55&# 4&p&/ 4i/e/&p5&# 4e#&# 5e7er'&/&#( 5e!e5!&'&&#( 4&# li#ieri/&! &# 4&p&/ 4i/eri'&. Re#/&# 4&p&/ 4il&5"5&# 4e#&# 7&r& 'e'6"&/ 5"r>& 5&li6r&!i 4&ri 6e6er&p& !e/ l&r"/&# !/&r &# /el&$ 4i5e/&$"i 59#!e#/r&!i#&
). Sele5/i>i/&! i/&!&/&" !pe!i:i!i/&! !"&/" 'e/94e &4&l&$ 5e'&'p"&##& &# $&#& 'e#"5"r &/ /er/e#/" !&;& !e7&r& 7er'&/ 4&# !e5!&'& 4e#&# &4&#& 59'p9#e# l&i# &# '"#5i# &4& 4&l&' '&/ri5! !&'pel. Sele5/i>i/&! !eri#5&li 4&p&/ 4i#&/&5&# !e6&&i 4er&;&/ pe#i'p&#&# 'e/94e &# 4il&5"5&# /er$&4&p !&'pel &# 'e#"# 6&$&# &# 4i/&'6&$5&#. Pe#i'p&#&# $&!il ;i5& &4& 'er"p&5&# !eli!i$ 4&ri $&!il ";i 5e4"&#& & !/&r &# 4iper9le$
F. Validasi Ulang / e!alidasi
Mer"p&5&# pe#"l&#&# 4&ri >&li4&!i pr9!e!. V&li4&!i i#i 4il&5"5&# !&&/ &4& per"6&$&# :9r'"l&!i( l95&!i pr94"5!i( &l&/ pr94"5!i( ;"'l&$ /i&p pr94"5!i !er/& !&&/ 4i/e'"5&# 6&/7$*pr94"5 &# /i4&5 'e'e#"$i !&r&/ 4&# >&li4&!i i#i /e/&p 4il&5"5&# !e7&r& 6er5&l& 8&l&"p"# /i4&5 /er;&4i per"6&$&#per"6&$&# /er!e6"/.
". #$mp$nen Validasi
V&li4&!i 'e'ili5i 59'p9#e# !e6&&i 6eri5"/% 1. F&!ili/&! * 6&#"#&# 2. Oper&/9r*per!9#&li&
Per!i&p&# >&li4&!i %
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Per!i&p&# >&li4&!i &. Pr&5"&li:i5&!i
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6. Kel&i5&#
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Installation qualification
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Spe!i:i5&!i 6&$&# 6&5"
Spe!i:i5&!i 6&$&# 5e'&!&# pri'er
7. Pr9!e4"r &#&li!i!
L&r"/&# pere&5!i
I#!/r"'e# p&r&'e/er
Pe#e/&p&# 5&4&r*p9/e#!i
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T&$&p >&li4&!i 6&$&# 6&5" &. Me#4&:/&r 6&$&# 6&5" "#/"5 !"&/" pr94"5 6. Me#7&ri 'i#i'&l 2 supplier "#/"5 !e/i&p 6&$&# 6&5" 7. Ji5& supplier 6&r" 5"#;"#i :&!ili/&! !"pplier /er!e6"/ 4. Me'per9le$ 7"pli5&# 4&# !er/i:i5&/ &#&li!i! 4&ri supplier e. Me#e/&p5&# !pe!i:i5&!i "#/"5 !e/i&p 6&$&# 6&5" :. Me#e/&p5&# pr9!e4"r pe#";i&# . Me#e/&p5&# pr9!e4"r pe#&'6il&# 7"pli5&# ;i5& 4i6"/"$5&# per!&r&/&# 5$"!"! $. Me#e/&p5&# 59#4i!i pe#i'p&#&# 9p/i'"' i.
Me#e/&p5&# "!i& !i'p&#
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T&#/&#&# /er$&4&p 6&$&# 6&5"
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1. Re#7&#& I#4"5 V&li4&!i Me#7&5"p pr9r&' >&li4&!i &li4&!i 6. Me#"!"# 	/& 59'i/e >&li4&!i 4&# !&/"&# /"&! 7. A5/i>i/&! >&li4&!i 4. M&7&'*6e#/"5 >&li4&!i e. Me#e/&p5&# ;&48&l >&li4&!i :. D95"'e# >&li4&!i ?9#/9$ F9r'&/ RIV
2. Pr9/959l V&li4&!i Mer"p&5&# 495"'e# /er/"li!
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'el&5!&#&5&#.
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F9r'"lir i!i&# "#/"5 pr9!e! pe#7&'p"r&#( pe#&8&!&# 4&# pe'eri5!&&# i#pr97e!!.
+. Pr&>&li4&!i Kei&/&# pr&>&li4&!i 'elip"/i( &. K&li6r&!i K&li6r&!i 4i6i#5&# 4e#&# 6&5"%
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B&7&&# /e'per&/"r 4&ri '&!i# '&!i# /er'959pel
N J"'l&$ /er'959pel &# 4i"#&5&# p&4& Te'per&/"r Di!/ri6"!i 2= Per6e4&&# /e'per&/"r 4&er&$ /er/i#i 4&# 4&er&$ /ere#4&$ 4&ri '&!i#'&!i# /er'959pel. T T $9/ T 79l4 T Per6e4&&# /e'per&/"r &# /er6e!&r T $9/ Te'per&/"r &# /er/i#i T 79l4 Te'per&/"r &# /ere#4&$ += Per6e4&&# /e'per&/"r /ere#4&$ 4&# /e'per&/"r !e//i# p&4& /i&p /er'959pel T T 79l4 T !e/ p9i#/. T Per6e4&&# /e'per&/"r &# /er5e7il T 79l4 Te'per&/"r &# /ere#4&$ T !e/ p9i#/ Te'per&/"re Se//i# &# 4i&/"r p&4& &l&/
6. K"&li:i5&!i S"&/" !i!/e' $&r"! 4i5"&li:i5&!i &&r 6er:"#!i 4&l&' pr9!e! &#
/er>&li4&!i.
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/er495"'e#/&!i 6&$8& 6&#"#&#( "/ili/&!( 4&# !i!/e' /el&$ /erp&!&# 4e#&# 6e#&r 4&# !e!"&i 4e#&# $&!il &# 4i$&r&p5&#. Ter4&p&/ ) /i#5&/&# 5"&li:i5&!i( &i/"% 1= K"&li:i5&!i De!&i# < esign !ualification * D= Se6el"' 4il&5"5&# 5"&li:i5&!i 4e!&i# $e#4&5l&$ /erle6i$ 4&$"l" 4i6"&/ !pe!i:i5&!i 4&ri :&!ili/&!( !!/e' &/&" &l&/ &# &5&# 4i"#&5&#. 2= K"&li:i5&!i I#!/&l&!i < Installation !ualification " I= S"&/" /i#4&5&# "#/"5 'e'&!/i5&# 6&$8& per&l&/&# &/&" !!/e' pe#"#;&# /el&$ 4ip&!&# 4e#&# 6&i5 !e!"&i !pe!i:i5&!i &# 4i/e#/"5&#.
+= K"&li:i5&!i Oper&!i9#&l
7. ?9#/9$ :9r'&/ 5"&li:i5&!i
4. ?9#/9$ 96e5 5"&li:i5&!i
- K&6i#e/ 4e#&# pe'&#&!
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Veri:i5&!i '94el 4&# #9'er !eri&l#& Veri:i5&!i &p&5&$ &4& 5er"!&5&# :i!i5 &# /erli$&/ Veri:i5&!i l95&!i pe'&!&#&# 4&# 7&r& pe'&!&#&# !e!"&i re59'e#4&!i 4&ri p&6ri5 pe'6"&/#&
+= O
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J&l&# + 6&/7$ "#/"5 /i&p pr94"5 4&# 4i&#&li!&
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p&r&'e/er 4i 6&8&$ i#i % Ke!er&&'&# &/ &5/i: K&4&r &ir
)= P
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J&l&# 9per&!i "#/"5 /i& !&'pel &# 6er6e4& Te#/"5&# /e'per&/"r pe#eri#&# 4&# 8&5/" 4&# !er/& 5&r&5/eri!/i5 pr94"5
). V&li4&!i Pr9!e! V&li4&!i pr9!e! &4&l&$ 5ei&/&# /er495"'e#/&!i "#/"5 'e'6"5/i5&# !"&/" pr9!e! !pe!i:i5 &5&# !e7&r& /er"!'e#er"! 'e#$&!il5&# pr94"5 &# 'e'e#"$i !pe!i:i5&!i 4&# !i:&/!i:&/ '"/" &# /el&$ 4i/e#/"5&# !e6el"'#& &li4&!i 4. K&li6r&!i i#!/r"'e# e. Pr9/959l 5"&li:i5&!i
Me'"&/ !e'"& $&!il /i#4&5&# 4&# pr9!e!( 'e'"&/ $&!il pe'eri5!&&# 4&# &#&li!i!( pe#il&i&# pe'e#"$&# per!&r&/&#*!pe!i:i5&!i &# 4i/e#/"5&#.
I. C$nt$&Validasi Validasi Pr$ses Pengemasan
U#/"5 'e'6eri5&# 6"5/i /er/"li! 4&# /er495"'e#/&!i 6&$8&%
-
Pr9!e! pe#e'&!&# &# 4il&5"5&# /el&$ !e!"&i 4e#&# pr9/&p Pr9!e! Pe#e'&!&# !er/& 'e'6eri5&# $&!il &# !e!"&i 4e#&# per!&r&/&# 4&# reproducible.
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Oper&/9r 59'pe/e#
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Ti4&5 /er;&4i mi$ up &#/&r pr94"5 4&# batch
,. H&l &# Di>&li4&!i
&. Ke'&!&# !/rip * 6li!/er
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J"'l&$ /&6le/ &# 4i5e'&! 4i!6i# ;"'l&$ /&6le/ &# 4i$&!il5&#
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Pe#&&#
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Te! 5e6979r&# !/rip * 6li!/er
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J"'l&$ /&6le/ 4&l&' !/rip * 6li!/er
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Kele#5&p&#
6. Ke'&!&# 69/9l
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J"'l&$ 69/9l &# 4i$&!il5&# 4i!6i# ;"'l&$ 7&ir&# &# 4i$&!il5&#
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V9l"'e per 69/9l
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Ke6979r&# /"/"p
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Kele#5&p&#
Validasi Pem(ersi&an
1. T";"&#
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U#/"5 'e'6eri5&# 6"5/i /er/"li! 4&# /er495"'e#/&!i 6&$8& 7&r& pe'6er!i$&# &# 4i"#&5&# /ep&/ 4&# 4&p&/ 4il&5"5&# 6er"l&#"l&#.
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Per&l&/&#*'e!i# &# 4i7"7i /i4&5 /er4&p&/ pe#&r"$ &# #e&/i>e 5&re#& e:e5 pe#7"7i&#.
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Oper&/9r &# 'el&5"5&# pe#7"7i&# 59'pe/e#( 'e#i5"/i pr9!e4"r pe'6er!i$&# 4&# per&l&/&# pe'6er!i$&# &# /el&$ 4i/e#/"5&#.
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?&r& pe#7"7i&# 'e#$&!il5&# /i#5&/ 5e6er!i$&# &# /el&$ 4i/e/&p5&#. Mi!&l% !i!& re!i4" 4&# 5&4&r 59#/&'i#&#.
2. ?&r& Pel&5!&#&&# &. Pe'ili$&# pr9!e4"r !&#i/&!i &# 4i";i 6. Pe'6"&/&# pr9/979l >&li4&!i 7. Pe#e/&p&# 'e/94e pe#&'6il&# !&'pel 4. Pe'6"&/&# le'6&r 5er;& >&li4&!i e. Pel&5!&#&&# >&li4&!i :. Pe#";i&# !&'pel . Pe#e#/"&# 7ri/eri& pe#eri'&&# $. Me'6"&/ 5e!i'p"l&# i.
Pe'6"&/&# l&p9r&# >&li4&!i
+. Pe#e/&p&# Pr9!e4"r Pe'6er!i$&# <6e5&! pr94"5* &/ &5/i:=
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B&$&$&# &# !"li/ 4i6er!i$&# <4&ri pe#&l&'&#=
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Pr94"5pr94"5 !"5&r l&r"/
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Pr94"5pr94"5 &# 'e#"# 6&$&# !&#&/ /95!i5( 5&r!i#9e#i5( '"/&e#i5( 4&# /er&/9e#i5.
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U#/"5 6&$&# &# !&'& 4ipili$ 49!i! &# le6i$ /i#i.
). Kri/eri& Al&/*Me!i# &# Di>&li4&!i &. Per&l&/&#*'e!i# 6&r" 6. U#/"5 'e!i# &# !&'& <'ere5( ;e#i!*/ipe= $&#& !&l&$ !&/" &# 4i>&li4&!i 7. Ji5& 4&l&' pr9!e! 'e#"#&5&# r&i&# 'e!i# &# 6er6e4& !e7&r& 6er5el&#;"/&# '&!i#'&!i# 'e!i# $&r"! /e/&p 4i>&li4&!i !e7&r& /erpi!&$. 4. Ji5& r&i&# 'e!i# 'er"p&5&# 59'6i#&!i 'e!i# &# pe'&#e#( >&li4&!i 6i!& 4il&5!&#&5&# 6er!&'&!&'&
H&l$&l l&i# &# perl" 4iper$&/i5&#%
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De!&i# per&l&/&# <&p&5&$ 6&#&5 pip&pip&( &p&5&$ &4& 5e!"li/&# "#/"5 'el&5"5&# !&'pli# 4&# le5"5&#le5"5&#=
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Te5#i5 sampling <'e/94e pe#&'6il&# !&'pel= swab test ( rinse sampling &/&" placebo sampling .
-
F9r'"l&!i %7&ir&#( !er6"5( &!ep/i5( !/eril( e5!ipie#.
Pe#e#/"&# T9/&l Re!i4"
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De#&# 7&r& 'e#;"'l&$5&# !i!& re!i4" 4&ri !e'"& 6&i&#.
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Me#59#>er!i5&# ;"'l&$ /9/&l re!i4" 4&ri !i!& re!i4" &# 4i!&'pel
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Ji5& /i4&5 &4& re!i4" &# /er4e/e5!i( per$i/"#&# !i!& re!i4" 'e#"#&5&# limit of detection.
. Kri/eri& pe#eri'&&# !&'pel%
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Sel"r"$ !i!& re!i4" &5&# 4i7e'&ri
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Si!& re!i4" &5&# /er7&'p"r !e7&r& $9'9e# p&4& pr94"5 !el&#;"/#&.
-
TIEL <%o$icological Insignificant #$posure &evel = &/&" 49!i! /er&pe/i5 /er5e7il per$&ri !e6&&i 6&$&# per$i/"#&#.
. Kri/eri& Pe#eri'&&# Pe'&#/&"&# ri!i59 /er;&4i#& 59#/&'i#&!i !il&#
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Kri/eri& 49!i!
7e'&r&# 6&$&# &5/i: /i4&5 le6i$ 4&ri 0(001 C 49!i!
$&ri&# '&5!i'&l per$&ri 4&ri pr94"5 !el&#;"/#&
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Kri/eri& pp'
pr94"5 6eri5"/#& 'e#"# /i4&5 le6i$ 4&ri 10
pp' 7e'&r&# pr94"5 !e6el"'#&.
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Ber!i$ !e7&r& >i!"&l
p&4& pel&/ &# /el&$ 4i6er!i$5&# /i4&5 /erli$&/
!e7&r& >i!"&l &4&#& !i!& pr94"5 !e6el"'#&.
DAFTAR PUSTAKA
BPOM( 201+( Petun'u( Operasional Penerapan Pedoman )ara Pembuatan Obat yang *ai( 2+2, Jili4 I( B&4&# Pe#&8&! O6&/ 4&# M&5&#&# Rep"6li5 I#49#e!i&( J&5&r/&.
?$&#( ?. ?.( Her'&# L&'( 3. ?. Lee( 4&#"eMi# Q$&#( 200)( Analytical -ethod alidation and Instrument Performance erification( J9$# ile S9#!( ?&#&4&. Er'er( J.H. 4&# M7B. Miller( 200( -ethod alidation in Pharmaceutical Analysis/ A 0uide to *est Practice( ileV7$. Verl& G'6H ?9( ei#$ei'. FDA( 1-,( Prescription rug -ar(eting Act, Sil>er Spri#. G&r( I.G. A. R9$'&#( 200,( 1imia armasi Analisis( P"!/&5& Bel&;&r( 39&5&r/&. He&l/$ ?&#&4&( 200-( alidation 0uidelines for Pharmaceutical osage orms, Dr" G994 M&#":&7/"ri# Pr&7/i7e! U#i/( ?&#&4&. I?H( 1--( alidation of Analytical Procedures/ %e$t and -ethodology,2
