Bioequivalence and Bioavailability Forum

❝ "...to ensure passing system suitability results."

❝

❝ Validation is to show suitability for the intended purpose. Mission accomplished!

Generally system suitability could be performed to assess whether the system runs within its spec’s before an analytical run (CCs, QCs, unknowns). Examples: Injecting blank extracts to condition new columns, checking retention times, capacity factors, peak symmetry & resolution, tuning the detector,
Of course, a procedure must exist and followed. Limiting SS to a certain number of injections is not a good idea. Deleting out-of-spec’s results is stupid. Better is sumfink like:

“The system suitability test passes if – after corrective measures if necessary – n subsequent (!) injections fulfill criteria X, Y, Z.”

Fully agree to your other points.
Didn’t Mr Trump say that for every new regulation two old ones have to be suspended? Lean state?