A question for those who live in the world of GMP/GLP.
We have a number of imaging systems for gels, including densitometers, CCD
Cameras etc. We have tried to address a system suitability test
(performance qulaification) for these. While we have processes in place, I
am never satisified that we have totally solved the issue.
For example, we can get step tablets (test cards effectively) from
suppliers like Kodak, but when we try to find a way to trace calibration to
a gold standard as we do successfully for weights, thermometers etc., the
trail either goes cold or the test proves never wholly suitable in our
eyes.
Has anyone addressed this and feel you have got it nailed?. Can you share
the information or thoughts. All debate is welcome.
Paul Cutler
SmithKline Beecham Pharmaceuticals
Harlow
UK