EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥...
Transcript of EµFÒG G FëG# - QST...5 ¯GxP f ] ¢ | × - í - J × à _ 8 - ! Å Ä 6 Ð ë å a * ÿ _ Q ÷ ¥...
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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
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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
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…
… SOP Standard Operating Procedure
(DQ)
(IQ) (OQ)
(PQ)
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QCIQ/OQ
QC
<< >>USP General Chapter <1058> Analytical Instrument Qualification
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IQ OQICH Q7A
) , ,
DQ IQ,OQ,PQDQ DQ IQ,OQ,PQ
DQ
IQOQPQ
EQ
Equipment Qualification
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DQ IQ,OQ PQDQ
IQ DQOQ
PQ
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(URS)
(FS
(DS
(PQ)
(OQ)
(IQ)
(DQ)
(Verification)
V << >> GAMP5 [ISPE]
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OQ SPD- 20A
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6 RSD(%)
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No. Caffeine Caffeine
RSD(%) [No.1 No.6]
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GC
20
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OQ GC-2010
No. C16 C16
RSD(%) [No.1 No.6]
No.1
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6 RSD(%)
21
LC SIL-20AXR
2222
10,00020,000
INJ LOAD
→→
!!
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1 FID23
GC FID
→→
!!
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PQ SPD-20A
R2
No. Methyl paraben μL
Methyl paraben
R2
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PQ
OQ
IQ
PM OQ
PM
=
=
==<< >> GAMP5 [ISPE]
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