Home Forums General Discussion Using rejected lot for Annual Stability Reply To: Using rejected lot for Annual Stability

John O’Neill
Post count: 75

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. :)