Bioequivalence and Bioavailability Forum

Dear Bani!

❝ Is there any upper limit of number of quality control samples that can be

❝ acquired in a single batch?

Since you posted in the 'Regulatives / Guidelines' category I guess you have done your homework already? FDA states in Section VI. (Acceptance Criteria for the Run):

The minimum number of samples (in multiples of three) should be at least 5% of the number of
unknown samples or six total QCs, whichever is greater.

So there's no upper limit.

❝ I have come across instances where number of total QC samples is more

❝ than 30% of the subject samples [...]

Wow! Must be a pretty stable method (no decrease of column performance, etc.)!

❝ [...] which sometime increases the chance of passing of the batch.

If we assume the common limits for acceptance and normal theory I would expect the same number of rejected batches.