Evaluating System Suitability - Agilent Technologies 8453 Operator's Manual

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Evaluating System Suitability

Sequence Summary Reporting
This chapter describes what the ChemStation can do to evaluate the
performance of both the analytical instrument before it is used for sample
analysis and the analytical method before it is used routinely and to check the
performance of analysis systems before, and during, routine analysis.
Evaluating the performance of both the analytical instrument before it is used
for sample analysis and the analytical method before it is used routinely is
good analytical practice. It is also a good idea to check the performance of
analysis systems before, and during, routine analysis. The ChemStation
software provides the tools to do these three types of tests automatically. An
instrument test can include the detector sensitivity, the precision of peak
retention/migration times and the precision of peak areas. A method test can
include precision of retention/migration times and amounts, the selectivity,
and the robustness of the method to day-to-day variance in operation. A
system test can include precision of amounts, resolution between two specific
peaks and peak tailing.
Laboratories which have to comply with:
• good Laboratory Practice regulations (GLP),
• good Manufacturing Practice regulations (GMP) and Current Good
• good Automated Laboratory Practice (GALP).
Laboratories are advised to perform these tests and to document the results
thoroughly. Laboratories which are part of a quality control system, for
example, to comply with ISO9000 certification, will have to demonstrate the
proper performance of their instruments.
The ChemStation collates results from several runs and evaluates them
statistically in the sequence summary report.
The tests are documented in a format which is generally accepted by
regulatory authorities and independent auditors. Statistics include:
• peak retention/migration time,
• peak area,
• amount,
232
Regression Coefficient
Standard Deviation (S)
Internally Stored Double Precision Number Access
Manufacturing Practice regulations (cGMP), and
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Understanding Your Agilent ChemStation
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