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!
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.
May 19, 2023
The lab is requesting additional material from controlled storage to complete testing before the due date. Is it safe to send it?
April 5, 2023
Historical data may suggest raising release limits to 95.0% or even higher but why mess with something not broken? Official agencies may influence your decision, providing motivation that is more governance than science.
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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!
