Annual Stability Matrix Interrupted
All Situation Room examples are constructed and not descriptions of actual events.
Published on: August 1, 2023
Walter Routh
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What is the stability situation?
We’ve just been informed by our planning group that they are not filling 100ct bottles this year since the 2022 volumes were increased to meet the 2023 demand. Several more 500ct batches are scheduled this year, but our commitment plainly requires 100ct, and in any case, we need to support the 2022 100ct batches at the very least.
How should this be resolved?
At least three options are available to us, so please indicate which you would recommend and why.
1. Have the packaging line execute a special stability run of 100ct. bottles this year. 2. Pull a 2022 100ct batch from the warehouse, which, although nearly a year beyond packaging would be placed on stability. We’d skip the 2023 annual batch and explain in our annual report. 3. Place a batch of 500ct bottles on for 2023 and notify the agency via the annual report that 100 ct. bottles will be placed on in the next year they’re packaged (probably 2024).
We’re happy to hear other suggestions!
We Want to Hear Your Thoughts!
April 26, 2025
While planning for a set of formal in use studies for their new ACE Inhibitor, a stability team found themselves in need of guidance. Can anyone point them to reliable resources for guidances or any other inputs to help them plan properly?
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.
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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!
