GMP in Pharmaceutical Industry
-
Upload
marvelousgrace -
Category
Documents
-
view
252 -
download
2
Transcript of GMP in Pharmaceutical Industry
-
7/31/2019 GMP in Pharmaceutical Industry
1/35
!!"#$%&
'(%)*+,-,
.(/$-01
/ / &2,3 % )
45&
(++1116666+*-0++,'-,%)*6
-
7/31/2019 GMP in Pharmaceutical Industry
2/35
35-
&
1-4
761
-41 8
35935: ;1$&
6
* 1 35
-
7/31/2019 GMP in Pharmaceutical Industry
3/35
35-
=(-*
,-#',6-71
7$
&$6
!"#$%&'!('#)#*#"+*"#!$, $(!)#!$#&))$%!$*)
'!!$
$ &1
6
& &$8
1 1 &6
1 6
8&&
$
$&
&6 1
1&1$
&6
,&.0?@:9!!@:/1A,9!!!:,
-
7/31/2019 GMP in Pharmaceutical Industry
4/35
35-
D
1$6$$&
21$6
= 1 $
6=1
)-6 1 $ & & $
&$=6
1 1
$6&1
1 & & 1
&1
966
& )
5:6
$9
:966&,*:6'
8 1$
& 1 $ $ & 1 $
6D&;$&11
$917
1:6
&;(
*+"(&" *%"$ - .
$ & 6 /1 9;>>: $ *&3
1& 6*
$&6-&
1
& $ 2 8
&6D $ & & $
7 $ $ 0= 2
$
-
7/31/2019 GMP in Pharmaceutical Industry
5/35
35-
C
,$ 3.& 7 7 7 7 7
*
9;:
3* 7 7 7 7
5 35 7 7 7 7 7
,& 3,& 7 7 7 7 7
$
$ 7 7 7 7 7
&$1
& $ 16 ' 7 0= 35
$
6 0= 1 3,'
3560=$&
1&8 &
835$6C0=
&1356&
351$$
$1&6
$%!/#%#)!$#!$!('#)#*#"+*"#!$
1%1!6-#/*;>!
8&
',;>!@&$91
',:6E1&
7@;>?"
;>@!9/1,!!!(?:6#
;>?6 # $
C ,5&&&0=7
1-1$966*6!!C:6@ %717;!"#9/1,!!!:6
" 1% &1
61765;!!!!&&1&1
;>@!9/1,!!!:6
-
7/31/2019 GMP in Pharmaceutical Industry
6/35
35-
@
$ 8 &
6%* 1
# 7 9/1 , !!!( ?F
!!D:6
'1$&$
$ 6 *$
&1178
$
6 >:1$&1
6$$
G&&
1 1H
1 $ 1& $
1111F
-
7/31/2019 GMP in Pharmaceutical Industry
7/35
35-
"
11$F
111I9/1;>>:6
& &&
-
7/31/2019 GMP in Pharmaceutical Industry
8/35
35-
?
7#1', 2
I9/1,!!!(":6
& $ & &)9!!;:1$
-
7/31/2019 GMP in Pharmaceutical Industry
9/35
35-
>
$1351&
0=(
0= 35 & $F%#35F
-*0
-
7/31/2019 GMP in Pharmaceutical Industry
10/35
35-
;!
';(35$
7&$
1 35
-
7/31/2019 GMP in Pharmaceutical Industry
11/35
35-
;;
=
-
7/31/2019 GMP in Pharmaceutical Industry
12/35
35-
;
&2$
-
7/31/2019 GMP in Pharmaceutical Industry
13/35
35-
;
%5% 1 & & ,$ %* !>+>;; ;>>C
-
7/31/2019 GMP in Pharmaceutical Industry
14/35
35-
;D
-$%#6
&16
0.,%$#$%#"#'!%*+*"#!&+$&12
50)7$&506-8
#B6 -
$$6
50) $
1 #B %#6 3 * 3,&
3.&353$
-6
*1353, &
1#B8&50)61%#,$
6)35
,& !! $ 6
950)!!":
50) 1
1 7 $
1$64#B
5 - $ &
B6-&
$#B6
#B-&
#-*&18&
%59%5%:6
-
7/31/2019 GMP in Pharmaceutical Industry
15/35
35-
;C
0,!!%#$%*+%)$#!$12
$ ', & $ %5% 50)
$&
6
1$ %5% 50)6 ',1
$$6-',
7$1135$
6
',35935:
-
7/31/2019 GMP in Pharmaceutical Industry
16/35
35-
;@
-$417
$&$6$-
$$154*1$&6
$ & 1 8 & -
&6$
68-
$
6 & )-
35
-6
-4$64
1-*&6
,
-
7/31/2019 GMP in Pharmaceutical Industry
17/35
35-
;"
4$74
;?@!1&B/&;?>!6
41 $ - 9 / %& F -$1
B#$!!":G$I;>C!6'
1 $ 6 4
1 ;>C! &
15'6),.&1
;>@C$),.9),.:;>"
4 9-$1 =4 B ,& !!@:6 $
* - $6 .6 1 ;>"; 9-$1 B #$
!!":6;>"?,,9,,:&
;>">9:6,/
5A==!/9;>"C:,&*!
/9;>"@:6;/;>">114&;!!!-F4
17 -6 -1 ;>?!1$
46)50
,,$14
-
7/31/2019 GMP in Pharmaceutical Industry
18/35
35-
;?
) F F ,$
$ F
% & $
F%$8
F$&&&F
10=35I9,,!!":6
;>?D,,1114
& 1 0=35 9%:6 0=35 1
$&;>>?0=$35!!
& ,,&61 &
,,&1;>?D,,7
F 7 1 1
&71&G6I&$
&1,,0=35$
0= 35 ,, 9*$
,,!!":6
' ;>>! ,, 0=&35
6 1 !!" & $
6,,&0=35
4GI1,,1*5
,&86-$11,,1
11$&$(
;6 ,6 ,6 ,-8-)D6 ,6
1;>?@F;>>;>>"
!!6,/49,/4:1&4;>>
-
7/31/2019 GMP in Pharmaceutical Industry
19/35
35-
;>
354
6.&1&
&6*"!!!&
11$
6,,$&44'
!!!G)*I4,;>>C
4.%,49$!!:4$&!!C,
G433I6
351&& ,,7
0= G1 I 9 7
$ / ,= )M 6:6 0=
,,6 4 9=4:
&135&
& 9 ( G
1IN:6 $ $ 1
$6=4$$&&
- $
&&494:6
00*
,,&35%,
56,,1
0=1GI601$
351& 6'
7F,,&9$$&1
&1:&76
&1 $ $
7616
11 35O$G$I
1 1 O &
-
7/31/2019 GMP in Pharmaceutical Industry
20/35
35-
!
$ 8 1 &6 35
$ & 6 ,, &
$35$
0=$6
=1357
17&&
4 L $1&6=
&18$1&
&$ 6 4.
356$G8I&1
G8I161&&
1(
GE1686/1
8 6/1 1
&8&68
7 1 1 71 1
$6
=I9-$1B!!!":6
1 $ $ 4.
70#9:1
G$ I$ GI 1 6
1$1
-
7/31/2019 GMP in Pharmaceutical Industry
21/35
35-
;
9
-
7/31/2019 GMP in Pharmaceutical Industry
22/35
35-
11 1 1 6
35
1 6 11 &
35(F
F8 FF 6
35G&I ;6
% $$ & =9=:
1 4 % 6 ,, 1
&&&
6
-$1&4
8$60711&
46 - DC &
8&60,,
2&1118F
1 35 6 -
GI135&6
$&6-&1
86,,$1
1&1$
6
1&35
- & &
& & ,,6 1 ( G-
4I9-$11B;!!":6
181&1
1&67GI
;-0/$*.!!"6
-
7/31/2019 GMP in Pharmaceutical Industry
23/35
35-
9/==:144&&
$35$&46
, $ 35 1 $1
$ $86 '7 &
,B$1&7
9%)-5=P:&,41356
01&&1
&
1 6 $ 35
O0&1&91&$
:611$
1 & 9 2 $ :6 4 $
GI60G
/.NI1$$352
6815)$&
8&1
&67
& $ ,=6 0 G&$I
$ 6 - 1 &
8358.1&
60$
$ & ,= 1 6
&1
1*.=B$
1&/$6
11$1507
1,, 1 9-$1 B>
!!":(
-
7/31/2019 GMP in Pharmaceutical Industry
24/35
35-
D
,( -4 1 1$
,,6
,,6 /
$GI9:6'$
GI6$1&&,,6
$,, 6 1 6
$$66
-0(1O
,(6,,$
&& 6 190 1
:6 ' 1 1 6 -
1 6 $
+&,,
$$6$9
1:6$
),).94/),).&:12
&,,686
1 $ 1 4 1 -
/ H 1
16'7
$&111
1&6O
$&16
6%$
& 6 - -
& -
6 - 1&1 6-
6),).$8H
& ),). ,,
-
7/31/2019 GMP in Pharmaceutical Industry
25/35
35-
C
6
6
' $1 1 1 7 1
&351860
1$1&49667:6
8&&$7
6 ' 7 1 '7 1 $ &
&
1 6 3$ G&I &
$
&$&
&6
!""""#"
$11=4BB11
),41&);>>!
4 & 6 1 $ 0= &
3& , ' 93,': 1 4
& 9 & ,-, 3& ':6 -
1 8 1 1 1
35491$11
8:(
G),;C!DC!&4&*94*:6
;>>!94/-(-1:6
1/ ,= G0=I6=
3$ 1 4* & $ 6
16,/911
,4*:1 &4O-1&
6
-
7/31/2019 GMP in Pharmaceutical Industry
26/35
35-
@
595:41-*
$),6BB1*6
1$
86 1 =B&
6118 1&
176
1&16BB60=1
356--$),
-16
G576BB1
6 ' 7 $ & / ;
76 $../ .*.,6-
&!!9DPC!.:657C
786-/;6
&6-17&
&),
67&&6
81F
&),1=B6'DC
4*16
G$4*6
), 1 1 L
1186-
6 ' $ & 1 1
1 7$6 ), & 1
$6),&*0B10=
$ 6 / 1 1 1 $
$6G$I1$
6=&1&*1
7611&1&4
-
7/31/2019 GMP in Pharmaceutical Industry
27/35
35-
"
-6 ), 1 * 1
$6)
, 4* 1 1 ),
60&&
$GI$4*6
-813,'35
1&&1&&
6
64&16-1!!1
,,$$$35&!!"6
1111
6-1,-,&
-*&8-*
118&1&,-,6
3$ $
&&11356
, 4 , 94,: $ 35
& 1 4, 9 &
4&:6
$"%"&
- $1 $ 50 -01 1
356M9%:41
& * & 1 356
9!!":&1181
$ 6 / 1 $ 4 $ &
#4-*%'1&&$&135
63560=#4
13567$
-
7/31/2019 GMP in Pharmaceutical Industry
28/35
-
7/31/2019 GMP in Pharmaceutical Industry
29/35
35-
>
35 I $ 9 !!C:6
=11
$ 6 ,,
90&:&0=35
86,,
&
6/116
76
-81
&9&:6
5*!$#$%(*4*!$
)-$&&
$ 1
1$352&
&6521
1)-1356
'11$ 135 &
&&7&4
-6 -46
* 7 F $
464
&&
$&3&,'63$
35 4
$ 1
& $ 1 8
6
-
7/31/2019 GMP in Pharmaceutical Industry
30/35
35-
!
886&&1
8&81
$6
'&16
7$$
( &7
6
-1&$135
16018
O011O
35O0135
O
8 1 $ 35
6 ,& 835 &
&8O- 35 8O
8 # 35 1
$60135
811
1$8O
-1& 1 & $35
1$$O
6
$ & -
4O
($
-
7/31/2019 GMP in Pharmaceutical Industry
31/35
35-
;
&66)9!!;:6G(":6G%#',35)(=$$1*I
/0(CC@!6
-*0)8)
0#-*069(++11166:.;?5
!!"6
-/69!!!:6G&35I)"!-$
667
-%&9!!":6G-%41I
9(++1116&6+%R41+!!"+-%41M6---
-6:.;@5!!"6
.6)660?@:6G-I)#
8(;"C6
50)50)69(++11166$6:.
;?5!!"6
6#
9(++11166$6++O-$SR3%R3%A-S@;:.
;@!!"6
-
7/31/2019 GMP in Pharmaceutical Industry
32/35
35-
5>6G7($
I
9(++18&616+&+!!D+>D;CD@;>!R6:.
C!!"6
6!!D6G0=(I
(231$","".
$63$0=!?:6
9(++18&616+&+!!D+>D;CD@;>!R;6:.
;"!!"6
''$%:
-;&'!($'!$
)3511&11
& C 6 -
6 135 6 '1
1 $ $
16
& 8 $
&6
8$1&8&
86
-
7/31/2019 GMP in Pharmaceutical Industry
33/35
35-
$ $1
1 6# 8 1
$6 + $ &$6
#
'5!!"%5%*35,&%351G
711
%1I9%5%!;5!!":6&%*%5%
9%#&-.41:
D+%*$1(
& $ 35 $
&9%5%1&!!":6-&
-*0E" $ 6 %# 3
&7$6
0;&)#''!#
- !! ', 1
9-*0E":&( 8 9E 5 * * )2 ) 5
*)*5:
8 9& ' %8 ,):
955,&,):
9, ) - M3-5&**+':
& 9 - .& - -/,&))&:
-
7/31/2019 GMP in Pharmaceutical Industry
34/35
-
7/31/2019 GMP in Pharmaceutical Industry
35/35
35-
= *,(G*,1&7(,
)I&