I have injection precision, standard concordance, tailing factor, efficiency and RSD% of all bracketing standards throughout the run in my system suitability test. If I have once ran the tests, what can I do without running it again. What FDA says?
E.g. if there is an pump error and it has been stopped. Can I restart without running the system suitability again? Can I run column wash program between the method injections?

Thanks

Anon,

Assuming you work in a GMP environment, you need to test for all your system suitability requirements described in your method every time you run the analysis, no way around that. If you have a pump error and it stops, you should rerun system suitability. If your detector turns off (as a result of the pump stopping - as most do - or even for some other reason) you definitely need to rerun system suitability. And hey, if your unsure, just rerun system suitability to be on the safe side. No harm in that.

One question David:

If the chromatogram runs for 30 minutes, but the two peaks of the system suitability runs in the first 10 minutes. Can we run different chromatogram times (the two methods are exact).

Thanks

Anon,

I have seen and run methods where the system suitability injections are shorter than the "sample" injections. Again, assuming you are a GMP facility and your method states you can have a shorter runtime for suitability than for samples, it shouldn't be a problem. If your method doesn't state that, making a revision of this nature to the method shouldn't require any revalidation. Good luck. I hope this helps.

David