The Computer Doesn’t Know My Product!
All Situation Room examples are constructed and not descriptions of actual events.
Published on: November 11, 2023
Walter Routh
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What is the stability situation?
Late last year we started tracking and trending stability data in real time using software that analyzes results entered by the testing lab each day. The system is designed to flag potentially aberrant results and send notifications to stability and lab management. The intention is for the labs to initially investigate the value to ensure no lab error caused the panic.
Last week one of our established oral dosage antacid type drugs was flagged as aberrant for potency at the 12-month interval and was projected to fail at 24 months vs. its 48-month shelf life.
Visually I can see that the first few intervals are flat, but on the lower side, and the 12-month interval suddenly drops. With such extensive historical data, stability folk like me are not worried, but the lab and QA management are ready to initiate a recall! The lab sees no hint of error on their side (of course) after their investigation that did not include any retesting.
I believe the batch was initially 1 to 2% lower than the main population, but that has been seen several times in the past and is well within the process limits. The relatively flat degradation pattern through 9-months is typical, so either the 12-month data is erroneous or simply represents a single sample on the low end, but still well within specification (>90%). I think we’re seeing some of the key pain points of our automated statistical tracking process and it just need’s tweaking—where should we go from here?
How should this be resolved?
Justify a potency re-test or perhaps add a data point for the next monthly interval? What would you do?
We Want to Hear Your Thoughts!
March 30, 2025
When it comes to filings we expect no surprises from stability data. One company found aberrant data like a rude April Fool’s joke, so what process can they implement to eliminate these surprises?
March 2, 2025
Your Honor, where do we turn if money is not available to purchase stability chambers and alternative storage options are not readily available? Budget timing and quality roadblocks are putting stability chamber space in danger of overflowing.
February 7, 2025
Upper management has a dangerously low awareness and vigilance of stability. They haven’t had a significant event or audit observation to raise alarms and put us at top of mind. As a result, we get the dregs of personnel and budget—this needs to change.
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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!
