Bioequivalence and Bioavailability Forum

Dear Prashant,

❝ Case 1. Suppose one of my batches failed for, QCs not meeting the

❝ acceptance criteria i.e. 7 out of 12 QCs failed.

In that case the results of this batch, including the QC results, do not need to be reported. Just keep the raw data in your archives, in case you are unlucky and get an inspection

❝ Case 2. One of my batches meets the acceptance criteria i.e. 3 out of 12

❝ QCs failed. So, should the failing QCs be asterisked and not considered

❝ for calculations?

Assessors will appreciate to have failing values identified in the report (with an asterisk or any other sign). But you should keep these results in the calculations. No guideline on this topic - but have a look at http://www.fda.gov/foi/warning_letters/archive/m2483n.pdf this warning letter, bottom of the first page and top of the second page.

Regards
Ohlbe

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Edit: Link correct for new FDA's site structure. [Helmut]