Professional Documents
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Qualification
GC Systems
(FID, NPD, ECD, FPD, TCD)
Temperature accuracy
and stability
Temperature uniformity
Injector and detector
temperature accuracy
Detector noise and drift
Gas flow rate accuracy
and split flow ratio
Injection precision
Detector linearity and
sample-to-sample carryover
IQInstallation
Qualification
Inventory of instruction
manuals, components
and serial numbers
Installation verification
PQPerformance
Qualification
System performance
and robustness
Data analysis verification
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multi-vendor
IQ OQ PQ services, call
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Qualification of GC &
GC/MS Systems
Laboratory Instrument Qualification
Performed & Documented in GLP Format
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TEMPERATURE ACCURACY
AND STABILITY
Oven set to 50, 150, 200, 250, and 300 C
and temperature measured with calibrated
thermocouples for accuracy and stability.
INJECTION PRECISION
Five repeated injections of
standard sample. Compare
area count and retention
time deviations.
DETECTOR LINEARITY
Five injections of increasing
concentrations of standard caffeine
samples, followed by HPLC water
injection. Compare linearity of area
counts, and check for carryover in
water blank.
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Analytical Sciences
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TEMPERATURE UNIFORMITY
Oven temperature is measured at
the top, middle, and bottom levels
with calibrated thermocouples for
uniformity.
SYSTEM PERFORMANCE
AND ROBUSTNESS
Typically an injection of a low
concentration sample, repeated five
times. Compare area count and
retention time deviations.