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. OpenLab provides the tools to do these three types of tests automatically. An instrument test can include the detector sensitivity, the precision of peak retention times and the precision of peak areas. A method test can include precision of retention 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 may have to comply with:
Good Laboratory Practice regulations (GLP),
Good Manufacturing Practice regulations (GMP) and Current Good Manufacturing Practice regulations (cGMP), and
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.
To collate the results from several runs and evaluate them statistically, OpenLab CDS offers a function to create result set summary reports. Different report templates are available for these summaries (for example, SequenceSummary_Extended.rdl). They can be adjusted as required.
The tests are documented in a format which is generally accepted by regulatory authorities and independent auditors. Statistics include:
peak retention time,
peak area,
amount,
peak height,
peak width at specific height,
peak symmetry,
peak tailing,
capacity factor (k´),
plate numbers,
resolution between peaks, and
selectivity relative to preceding peak.
Extended performance results are calculated only for calibrated compounds, ensuring characterization by retention times and compound names.
A typical system performance test report contains the following performance results:
column details,
processing method,
sample information,
acquisition information,
signal description and baseline noise determination, and
signal labeled with either retention times, or compound names.
In addition, the following information is generated for each calibrated compound in the chromatogram:
retention/migration time,
k´,
symmetry,
peak width,
plate number,
resolution,
signal-to-noise ratio, and
compound name.