A Commercial OOS Predicament
All Situation Room examples are constructed and not descriptions of actual events.
Published on: November 7, 2022
Walter Routh
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What is the stability situation?
It feels like the sky is falling. Two months prior to expiry we have an OOS for our commercial oral antibiotic tablets—one of the degradants exceeded the upper specification limit at our 18-month interval. The sample was pulled as scheduled on October 25th and the next pull will be made at the expiration interval on 28-Dec-2022. The Degradation Impurities by HPLC assay was completed and verified within a week of the pull, but the OOS news was not expected. The laboratory quickly investigated, and not only did they find no error, a second analyst confirmed the original with both replicates, so they are expected to formally close out their documentation tomorrow, which will be our official date of recognition.
Historical data shows that this degradant increases linearly over time, as did this batch. It is a process-controlled impurity, so it started at the same magnitude and increased roughly at the same rate as other batches through the 12-month interval but has now popped over the line. Meanwhile, we have another commercial batch on stability from the same year of manufacture that hit the 12-month interval three months ago and showed marginal results. We also have two batches from the previous year that both expired within specifications.
While the plant is evaluating manufacturing batch records, QA is checking for any uptick in complaints, and we are checking for any potential environmental causes or anything obvious—like a hole in the bottles or something. This is a frequently manufactured product with multiple batches on the market and in distribution.
Assuming we find no smoking gun for this batch, what is the next course of action you would recommend? Can we avoid a recall?
How should this be resolved?
The clock demands that the results be reported to the Regulatory Authorites with actions and conclusions to date. They may ask for a decision to recall, but it could be worth emphasizing the on-going quality/manufacturing investigations, especially if they can be wrapped up in a very short period of time. What would you do if this was your situation?
We Want to Hear Your Thoughts!
September 30, 2023
Many of us have been there; you have some initial stability data that would save a lot of time and money if you didn't have to support it with further studies, but sometimes circumstances cast regulatory shadows that bring about difficult decisions. What to do?
August 23, 2023
When a study will be significantly impacted by delayed enrollment of an annual batch none of the options are appealing. We look forward to your discussion of the preferred action.
August 1, 2023
Facing a change in packaging volume for our prescription digestive aid capsules, we're weighing three options to maintain our stability commitment, which alternates between 100ct and 500ct bottles each year, despite the fact that 100ct bottles will not be filled in 2023.
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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!
