Annual Stability Matrix Interrupted

All Situation Room examples are constructed and not descriptions of actual events.

Published on: August 1, 2023
Walter Routh
Categories: The Situation Room
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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!

  • 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.

  • January 4, 2025

    Samples swapped identities when human error caused incorrect storage conditions to be tested, but the only evidence is historical data trends. How can they prevent the error and shore up sample integrity?

  • December 7, 2024

    When an unidentified impurity pops up on stability testing of a topical drug-containing cosmetic, internal political conflict erupts regarding filing strategies. Should they delay filing and ID the impurity or push ahead favoring the cosmetic side of the product?

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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!

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!