Bioequivalence and Bioavailability Forum

Dear Geokad,
Thank you for your reply.
We have the codes, related to this issue is
o Processing error,
o System failure,
o Above upper limit of quantification (ULOQ) and
o Others (for other repeats which is not defined in the SOP) etc...

So I think...
It's not ULOQ because it is within the calibration range. (second time repeat analysis)
It's not system failure because rest of the batch was passed.

So is it comes under either processing error or others. (we already proved dilution integrity in validation itself)


Thank you

Regards
nvs