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Presentation gmp
1.
Good Manufacturing Practice
2.
GMP = Good
Manufacturing Practice กก !"#$%&'()ก*+, $-* *+. ก*+/'ก*+012 ก3 %&'()04*)!+ ก-#ก*+. 012 ก3 %&'()ก*+, $-* *+.
3.
GMP
??? ก ก ! " ก #$%&'$ () *+ " #,#$%& -%)&%& +'$ " . + /#$%& 01 2 $ 30
4.
( , ก0(ก)
GMP 4GMP +*12 ก 5 2ก '$ ! ( + . 02 !! " %6 & 0 ก% ( + +1 $ 30'ก1 #,) %73 8
5.
( +. ;
2 GMP $ ( + .02 2ก #$%& !ก1 " ก% & 0&1 #,) %73 5 2ก ก 0,1 90 2.&( : :1 '+$2( , & ": 0 ก ( , 2% * , ($ ) 01 2+ .% ?%3 . 2(+ )"!" #,) %73 " 2 2 ( +. @$@
6.
ก #$%&
+1/,ก $ก GMP ก% ก AB 2: 7 " ก% ก .,; .0 ./ #$%& 0,1 90 2.&( : #, -%)&%2 ก% ก !C) D(0 #$#$%&$ & $2 .,; .0$,ก '$ #$ก /,ก % ก & +ก + 0
7.
GMP %& !5)ก6
7*8#9:#(;<2-9!+ %=>%8 1. !+ ก*=ก+ %+ 90* *+ 012(B##%&193) F.=. 2543 (B##%&239) F.=.2544 +J&-9 ก*, $ :+J&-97J- :+J&-9(;<()ก*+, $ ก*+ กK#+ก3*-* *+(GMP 012 ก3 %& >!) 2. !+ ก*=ก+ %+ 90* *+ 012(B##%&220) F.=. 2544 +J&-9)MN*#+OP:()P*;) #++/1!Q'0)%(B##%&3) (GMP )MN* #+OP:)
8.
GMP +กE
+ 0 2 ) (+#$)2 )'$() ก +1 -%)&%& + & 2 ( 27 6 1(02 )#% : ) ก 2 () *+ . ก2 ก +ก '$ 0 ( 0.) '$ . ก2 . ? .* !2 ( (..!.)
9.
-)$+*8%&-*/ ก'2RM)ก#-* *+
/N* )ก !5) 3 !+ P% 1. -)$+*8%*9; P*F 7*84R9 ก*+7 ;JM-/1 )%+8%& %N* ( < ก'O+:-8ST()-* *+ ;T) #:% +8 ( .'$ : GH2. &*ก AB +ก ก% ! กก ": (&/* %) +1+ * 3 2+ 2": +1. '$ ก () *+ ก #$%& +1 " ก% ก AB (1 2ก )( ก #$%&'$ ก .12&$ ! ก -%)&%2 2 ก2 +1/,ก.* $ก6
10.
-)$+*8%&-*/ ก'2RM)ก#-* *+
/N* )ก !5) 3 !+ P% 2. -)$+*8%*9 :7 7*84R 9 ก*+7 0*+ :7 %& !5 ) -)$+*8$T-012P*F2-97)138-8ST()-* *+ ;T) 0 I1 '+$2 0 ( +. . +I1 : + $1 $ (! )) (+ 2. %6 ก% H GH2++ ก ก% ก(1 กE + 0ก ! กC)(&/* %) ก ": 0 ( +. '$ . + +1/,ก& 2 " ก% ก AB "
11.
-)$+*8%&-*/ ก'2RM)ก#-* *+
/N* )ก !5) 3 !+ P% 3. -)$+*8%*9ก*8P*F 7*84R 9 ก*+7 $41 ! ก! -7%& !5)-)$+*8-8ST()-* *+ ;T) =3>7< 96'ก( 967$ '$ (. * J . &* 2ก AB + ! กก AB 2 96 + 96'ก( 967$ '$ 96(. * J + ! ก(&/* % ) 2+ ก '&ก ก 23 : $ K'$ &ก$2.,1
12.
GMP + 2
3 GMP 012 ก3 %& >! !5) ก ก %&)N*>!(;<!"#$0N* +#-* *+%1ก!+ P% GMP BF* , $P !5) ก ก 2<-กN* )'%& F&72RM)/*ก GMP %& >!
13.
ก
GMP .* $ก6 ( ) $*+/H2 • 04*)%&$M9 -*:*+, $ • :+J&-97J- :+J&-9/ก+ -1!ก+ %&(;<()ก*+, $ • ก*+: #:17ก+ # )ก*+, $ • ก*+012*P#* • ก*+#N*+19+ก3* ก*+%N*: *70 -*' • #1: *ก+ ,S<!"#$9*)
14.
ก
GMP ) %73 ) $*+/H2 • 04*)%$M9 -*:*+, $ & • :+J&-97J- :+J&-9/ก+ -1!ก+ ก*+, $ • T9)MN* • ก*+!+#:1 P*F)M* N • P*;) #++/1 • 0*+%N*: *70 -*' UT* ;JM- • ก*+#++/1 • ก*+: #:17:1 P*F7*$+V*) • ก*+012*P#* • #1: *ก+ 012 ก3 ,S<!"#$9*) • #)%Rก +*89*)
15.
ก
GMP .* $ก6 (
16.
GMP
7*$+V*) GMP 71T9 )<)()ก*+ '-)$+*8()-* *+%M9 3 !+ P%2<*9$<) WR&972<-กN* )' 0*7*+4- #*8F- !5)09 2!>'< '9$T->!)M
17.
2<-%& 1 :
./ &2 '$ #$%& 04*)%&$M9 &2 0,1) % ( . +1 0,1"ก$' $12+$ %6 ++ & ก 5 2ก ก AB
18.
2<-%& 1 :
./ &2 '$ #$%& (&1 ) -*:*+, $ ก')) #$%&" + 02 " ก #$%& +ก ) 0 ก 9 '$ () *+ * 3,+% 21 0&1 ก ) *2 ก6 '$ ( +. ')12'0ก ก #$%& (&/* %) 3 : ) !* & ก #$%& . .1( ! ก ก . + / 5 2ก .&( 7 .,1 #$%& &, &1 2 +1: * ! ก(. * 2 N . % '$ ( + . 0) ' C2' 2 +1: * + ( +$ 02 ก ( +. 3: 2":& 2+ 2 ) 0 '$ + 2+ *ก 02 '$ + .+
19.
2<-%& 2 :
2+ 2!ก '$ * ก ":" ก #$%& 3: * ก " ก #$%& .+#.ก) & 2 ! ก(. * +1 -%ก%%0 ก) +1 %6 +1 . %+ ก ก')) &% &2 2+ 2!ก '$ * ก ": + .+ &2 H2/H2ก AB ! ก% H ":2 . (ก .+ / ( +. 21 0'$ (/H2 2+ 2!ก '$ * ก " ก #$%&& 2 02 'ก1ก -%)&%2
20.
2<-%& 3 :
ก () *+ก )( ก #$%& ก*+'N * ))ก*+%1 ก 2M ) $-) $< - 97 ก*+: #:1 7 $*7 ก 012*P#* %&' $M9 $Tก*+$+ /+# $41'# 0T ),07()ก*+, $-* *+ ก*+2)8<*8 ก*+/' $+87 ก*+, $ ก*+#++/1 ก*+ กK#+ก3*-* *+ ก*+2)0T9 $41'# 0T ),07()ก*+, $-* *+ & 2+ก $ ก" 0,1" .3 . +* 3 + . )":" ก #$%& . )) %73 & 2$ 2 ( +. & + ( +! & 2 กC) ก6 (&/* %)3 0"&.3 ( 5 2ก ก AB +ก +* (0 .&O ก 2(&/* %)'$ .1( #.+ 01 2+ .% ?%3
21.
2<-%& 3 :
ก () *+ก )( ก #$%& (&1 ) P*;) #++/1-* *+ P*;) %&(;<2)4T*8 $41'# 0T ),07() ก*+, $-* *+ & 2 0,1" .3 + .+ '$ +1 " ก% ก AB ก) " (1 2ก #$%& )MN* )MN* 2K9 >-)MN* %&07,0ก#-* *+ & 2+ * 3 + & & + ก 9ก (2. ? .* 2 ' C2 '$ ) %73 '$ ":" .3 /,ก.* $ก6
22.
2<-%& 3 :
ก () *+ก )( ก #$%& (&1 ) ก*+, $ ก*+ กK#+ก3* 2)8<*8 2)0T9 & 2 5 2ก ก AB '$ 5 2ก ก . +.$ 0 2 '$ 3 : ) !* (0 /'%N*#)%Rก +*89*) #$ก & (!(% #$%&3 : % '$ %+ ก #$%& 2#$%&3 (+ 2( P #$%& 7 0 กC)) Hก'$ 02 ( 01 2 0 2 P
23.
2<-%& 4 :
ก .* 3%) $ ":3 0" 7 22 & 2 . '$ ! " +ก ) *2 * 3 & + ( +! ! " + 2.(+'$ 1 2$ 2+ 2.(+" 02 . )#, -%)&%2 '$ & 2/,ก.* $ก6 + * ก " ก $ 2+ 01 2 )/( '$ & 2'0ก &1 2 ก! ก) % ( #$%& +1 N .,1) % ( #$%&7 0& 2 ! " + 1 2$ 2+ " ) % ( #$%&" 02 '$ + * ก ก $ 2+ 01 2 )/( ! " +(% ? ก 5 2ก '$ ก ! .&('$ '+$2" ./ #$% & & + ( + + .+ ! " +3 : 2 ) 0 +,$Q 0 +Q N " ! ( 02 '$ + ))ก ! 0 +,$Q 0 + .+
24.
2<-%& 5 :
ก ) *2 ก6 '$ ก ( +. &( ./ #$%&& 2 ( +. '$ ก6 " 0,1" .3 . /,ก.* $ก6 7 0.+ .+ & 2 ( +. ,'$'$ กC) ก6 2+ 2!ก '$ * ก ก #$%&" 0,1" .3 . 2ก1 '$ $2ก #$%& #%( 2 2+ '$ * ก ก #$%& .+#.ก) & 2 (+ . 01 2.+ .+ 2+ 2!ก '$ * ก ก #$% & & 2+ก & (!. )'$ ) *2 ก6 " 0,1" .3 ":2 01 2+ .% ?%3 .+ .+ ก ":. + ":$ 2 ( +. I1 : '$ ก #$%& 3 0"& 2 $ 30 '$ ก ! กC). + ( '0ก กC)! ก) % ( กC) + 50 )* 01 2: ! 5 2ก ก ":#%
25.
2<-%& 6 :
)* $ ก '$ #, -%)&%2 ,S<!"#$9*)()#+ , $$<-9>7T !5)O+:$'$T- $*7%&กN* )'O'8 ก6ก+ %+ 9 ,S<!"#$9*)%1ก:) ()2 %&'N* ))ก*+, $ 7ก*+07,0O'8$+9 ก#-* *+ +J -0T ),072-9-* *+ $< -90 7 0JM -,<* %&0 -*' 7* 07ก#ก*+!"#$9*) < * 97J - ( < 0 -*'%1 ก :+M 9 กT - ) +& 7 !"#$9*) 9ก*+!) !YZ - ) ก*+(;< 41 9 7J - : +-8ST ( )0P*F%& 07#S + 0 -*' %N * '< 8 0'1 %& > 7T 7 0*+ *8 1 ' --ก7* !) !YZ-)-* *+ 2-9 WR7,T*)>7T>'<
26.
2<-%& 6 :
)* $ ก '$ #, -%)&%2 (&1 ) ก+ >7T 0 7419 7J -$< -977*$+ก*+( < F)ก9*) < * 97J - K # 2)( < 0 -*' )-ก/*ก)M$<-9>7T0 7 :+J&-9!+ '#$T*9[ : +0 7,<*!Q' !*ก : +7ก*+]ก-#+7 %#% ) $+ /0-#: *7+S< : *7 2<*(/2-9 ,S<!"#$9*)()ก*+!"#$$)'<*)012 ก3 %& >! : *7+S<()ก*+ , $-* *+$*7: *7 7* 07 F89F- %M9กT-)ก*++# 2<*%N*9*) : +! Sก^9/$0N*)Rก%&' FJ&-ก+ $1<)( < ก': *7+#,';-#$T--* *+%& , $
27.
70:
2 GMP ': *7 0&89()ก*+!) !YZ-)2-9-* *+ ก*+ +8ก0):<* :J)ก # ก*+!"#$$*7ก6 7*8 !5)+ ##%& ! &8)ก*+$+ /0-#, $P 2M)01'%<*8 !5) + ##ก*+!_-9ก)!^` *$*7 กก*+!+ ก):1 P*F + ## HACCP !5)+ ##%&0*7*+4(;<: #:17-)$+*8/*ก /1 )%+ 8 0*+ :7 0& 9 ! ก! -7>'< - 8T * 97 !+ 0% P*F >7T0M) ! J-9 ;T 8!_ - 9ก)ก*+0S ` 0 8 /*กก*+%& , $P ก'ก*+ !) !YZ-) +J->7T !5)>!$*72<-กN* )'
28.
70:
2 GMP (&1 ) !5)+ ##%&0*7*+4(;<+T 7ก#+ ##:1 P*F-J&) + ## HACCP ()7*$+V*)-* *++ T*9!+ %= !5)%& 8-7+#()+ '#0*ก T*0*7*+4(;<0+<*9: *77&)(/()ก*+ , $-* *+( <! -'P8 0+<*9: *7 $ก$T*9()ก*+ 2T92)()$ *'()!+ %= $T*9!+ %=
29.
$ -8T*9#+3%%&>'<+#ก*++-9+#7*$+V*) GMP #+3%
/+`OP:P -* *+(CPF) /N*ก'(7 *;)) % ?* ก%! ก6& *&. ก + ก $02.&('$ #$%& !ก .&( 2" 9'$ &1 2 9 7 0ก % ?* ก% !.1 ( " ;1 0,1 " 9 0 ?* ก%! %+& &2'&1ก ! (&/* %) ":" ก #$%& .&(ก ?*.&( ก $02.&(" :%2 %:0 ก ' , .&( ก #$%& . C! , ก ก * 3 (2! * 3 2G K %+&2'&1 K +! /H2#,) %73 &$ :1(2 2ก #$%& '$ ก ! 1 0 ) &ก ก * 3 +1 ! ก 0,1 R 2 ( + $ 30 1 ก'&1 (+/H2 H2/H2 * 3 .: &% '$ * 1 273: ก (0 2 (+/H2 ก $ ก(&/* %) '$ #,#$%& * 3 )( ก #$%& ก .12 '$ ก ! 1 0.% ! /H2+ #,) %73 ))+ & * 3 '$ ( + $ 30
30.
#, ) %
73 &1 2& 2ก ( + : + " ) % 73 (1 * 3 '$ $ 30 G K& ก/H2 ( +. ; 2ก$1 ( !H2 ! ))+ & * 3 '$ ( + $ 30 0 + )" ) : &% GH2 (+/H2 ))+ & & ก #$%& (GMP), ))(% & 0 '$ () *+!* (%กS& (HACCP), ))) % * 3 (ISO9001 '$ ISO22000) ก! ก )).* 9 .& '$ ก ! ก .* +0! (1 ("! $ก" ก #$% & 2G K + (+ก) ))& (!. ) 0 ก$) '$ ก ! ก ( + $ 30 + .% ?%3 '$( " ) %6 . + /! ก ก) ] ; * 3 01 2 ( C ( (+ 2+ )) 0ก .% + .% ?%3 .,2
31.
กก ... !%& 3
/ ( 0%2 IM-4RA 51-6616-008-4 0 * ก6 0%2 ( IM-4RA 51-6616-017-5 0 ก &! ! ! #$ IM-4RA 51-6616-302-1 ... 6 * ! ก%! IM-4RA 51-6616-363-3
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