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![Page 1: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/1.jpg)
![Page 2: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/2.jpg)
3
4
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5
GxP
GLP GCP
GMP
GxPGMP
GxP Good x practice x
GLP - laboratory -GCP - clinical -GMP - manufacturing -GQP - quality -GVP - vigilance -
GMP
6
cGMPFDA Part 211 25 Personnel
qualifications Personnel qualifications
FDA Qualification
Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS (April, 1996)
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7
179
333
/ /
8
1.0nm
![Page 5: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/5.jpg)
9
…
… SOP Standard Operating Procedure
(DQ)
(IQ) (OQ)
(PQ)
10
QCIQ/OQ
QC
<< >>USP General Chapter <1058> Analytical Instrument Qualification
![Page 6: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/6.jpg)
11
IQ OQICH Q7A
) , ,
DQ IQ,OQ,PQDQ DQ IQ,OQ,PQ
DQ
IQOQPQ
EQ
Equipment Qualification
12
DQ IQ,OQ PQDQ
IQ DQOQ
PQ
![Page 7: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/7.jpg)
13
(URS)
(FS
(DS
(PQ)
(OQ)
(IQ)
(DQ)
(Verification)
V << >> GAMP5 [ISPE]
14
![Page 8: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/8.jpg)
15
16
![Page 9: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/9.jpg)
17
OQ SPD- 20A
18
6 RSD(%)
18
No. Caffeine Caffeine
RSD(%) [No.1 No.6]
![Page 10: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/10.jpg)
19
GC
20
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OQ GC-2010
No. C16 C16
RSD(%) [No.1 No.6]
No.1
21
6 RSD(%)
21
LC SIL-20AXR
2222
10,00020,000
INJ LOAD
→→
!!
![Page 12: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/12.jpg)
23
1 FID23
GC FID
→→
!!
24
PQ SPD-20A
R2
No. Methyl paraben μL
Methyl paraben
R2
![Page 13: EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥ ' ø - å a ë å a ¯ Q Ì 4 ' ¥ ' ø -å a GLP GCP b · 2 W b · - 2 W s GMP](https://reader031.dokumen.tips/reader031/viewer/2022012006/60f8ad04aa5a073c34565564/html5/thumbnails/13.jpg)
25
PQ
OQ
IQ
PM OQ
PM
=
=
==<< >> GAMP5 [ISPE]
2626
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