Wow, This “Refrigerated” Sample Feels Warm!
All Situation Room examples are constructed and not descriptions of actual events.
Published on: November 1, 2025
Walter Routh
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What is the stability situation?
The lab submitted results from a long-term (5°C) and an accelerated (25°C) sample that we pulled last week at the 3-month time point. Great turnaround, but with really screwy results. The assay is flat for the accelerated sample and dropped 3% for the long-term sample, when of course, the opposite was expected. At first, we thought it was the lab, no. Then we thought it was a labeling error, no. Then we discovered 6 sample bottles placed in the long-term chamber and 24 in the accelerated chamber-all neatly labeled NOT for the chamber they were in. This is the first of our three post-approval commitment batches.
So, accelerated has plenty of material, but long-term has only exactly enough material to send one bottle to the lab through our proposed 36-month shelf-life. We are concerned about the risk of needing additional material for testing at later time points so we checked availability. The warehouse said no dice, this first lot rushed out the doors. There are 6 bottles held as reserve samples in an equally qualified chamber, just not the stability area.
Please disregard our obvious sample control and inventory process concerns and try to help us resolve this situation first.
How should this be resolved?
We see three possible solutions:
1. Put a 4th lot on, assuming it will be manufactured soon, and call this one a bust. 2. Since long-term is at 5°C, “borrow” some reserve sample material. 3. Proceed with the study as is and hope for the best.
Which one or multiple of these options would you implement if you were in this situation? Do you see other better options?
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A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
