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.
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. :)
If you have not yet signed up for the StabilityHub newsletter, join hundreds of other stabilitarians to get the latest news, publications, job opportunities and more!
By submitting this form, you are consenting to receive emails from: StabilityHub, You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email. Emails are serviced by Constant Contact