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TRANSCRIPT
-0025-01
ATn) (WTn) (mg) ( )1 #DIV/0!2 #DIV/0!3 #DIV/0!
AVE #DIV/0!SD #DIV/0!
RSD #DIV/0!
(%) WS/WTn×P×ATn/AS×a/b×k
/
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CSV
GMP/GQP
GMP/GQP
GMP/GQP
http://www.fpmaj.gr.jp/documents/sysutem666.pdf
GMP/GQP
GMP
GMP/GQP
GMP/GQP
PLC
11 / 32
http://www.fpmaj.gr.jp/documents/sysutem666.pdf
CSV
IT IT IT
Y21041 1 PLC 3 2000/06/06 2012/01/10
Y12001 1 PLC 3 2001/01/26 2012/01/06 11003
2.1
IT
LIMS 3.2
4 2008/04/11 2008/04/20 MM 13021 13022 1
13023 2
13024
13025 HPLC
20188 QC 1.2 4 Excel2001 2004/06/12
22530 1 A 2.1 4 Excel2007 2008/06/15 CD
22531 1.3 4 Excel2007 2008/08/01
IT
20227 QA SAP 2.1 4 2003/06/27
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Y12001 1
2012/01/06
Y12010
1
2012/01/06
Y21001 PTP
1 2012/01/10 PTP
Y21041
1 2012/01/10
Y40002
2012/02/01
10110
GMP
2012/01/11
10112
GQP
2012/01/11
Y51005 HPLC 2012/01/11
HPLC
17 / 32
: -001-01 : 201X-00-00
: : GMP GQP : : 9
GQP GMP
22
10 21 1021 11
GQP GMP
22 10 21 1021 11
-1
27 / 32
: -001-01 : 201X-00-00
: : : :
( 22 l0 21
1021
11 ) (GXX-001-01)
(1)
(2)
(3)
(4)
(5)
(6)
(7) ( )
(8)
(9)
.
3.1
3.1.1
3.1.2
(
)
3.1.3
3.2
3.2.1
)
( ) 4.1.2
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3.2.2
( )
3.2.3
3.2.4
3.1.2
,
3.3
3.3.1
3.2.l
,
3.3.2
3.2.1
3.3.3
(Service Level Agreement: SLA)
3.4
3.5