Using rejected lot for Annual Stability

[rbrisset]

#24900

I am checking to see if other companies may have used a rejected lot for an annual stability lot? Where I work we have circumstance where a lot will be rejected due to the incorrect expiry date printed on the label which does not have any impact on product quality. However, I have never seen a lot rejected (regardless of the reason) used as an annual stability lot since it is not representative of material distributed in the market.

[John O’Neill]

#24940

Interesting scenario; nothing wrong with the science of it, but waves a red flag to regulators. If your in-house Quality and Regulatory Affairs are okay with it, the RA folks could ask the officials for permission. Would be fascinating to hear their response, but I would predict a “sorry, but no” response. Any of our colleagues have experiences they’d like to share? I’ve been around long enough to have heard of rejected product routinely shunted for Stability study purposes, but that was back more than 30 years ago and not by any of my employers. :)

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