Sample Label Chaos

As the manager of the stability program, I got a call from the analytical lab yesterday telling me that they’d received three samples from us that were all the same lot from different storage conditions (5°C, 25°C/60%RH and 30°C/75%RH) but with a label discrepancy. The lab technician noticed that 5°C sample was labeled as a 6-month interval while the other two were for 3-months and she knows the lot was not even packaged 6 months ago.

This study is one of three primary batches and key to our regulatory strategy for an NDA filing in less than a year. We strive to demonstrate absolute control over our stability inventory for the benefit of regulators by pre-labeling all samples with storage condition, pull ID, and even the pull date. In this case the 6-month pull date on the label is the same as the date on the 3-month samples. Obviously, it was a typo that got overlooked in the verification and study launch process, but my management is questioning the integrity of this and all studies associated with this product that are expected to be included in the submission.

How can I convince them that this is not the end of the world, and that this study is perfectly submissible? Also, how can I convince them of the integrity of the nine other related studies that were all launched in very close succession about three months ago?

It seems like they’re overreacting a bit. You’ve barely had time to investigate, but I assume you’ll be checking all inventory, if you haven’t already, and can demonstrate that this is a one-off or two-off situation. If it’s a systemic problem, then you are open to serious questions from an inspector, and the root causes of this error must be fixed quickly.