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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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179
333
/ /
8
1.0nm
9
…
… SOP Standard Operating Procedure
(DQ)
(IQ) (OQ)
(PQ)
10
QCIQ/OQ
QC
<< >>USP General Chapter <1058> Analytical Instrument Qualification
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
13
(URS)
(FS
(DS
(PQ)
(OQ)
(IQ)
(DQ)
(Verification)
V << >> GAMP5 [ISPE]
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15
16
17
OQ SPD- 20A
18
6 RSD(%)
18
No. Caffeine Caffeine
RSD(%) [No.1 No.6]
19
GC
20
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
→→
!!
23
1 FID23
GC FID
→→
!!
24
PQ SPD-20A
R2
No. Methyl paraben μL
Methyl paraben
R2
25
PQ
OQ
IQ
PM OQ
PM
=
=
==<< >> GAMP5 [ISPE]
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