Delayed Enrollment, and Not For The Kids’ Elementary School
All Situation Room examples are constructed and not descriptions of actual events.
Published on: August 23, 2023
Walter Routh
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What is the stability situation?
To our chagrin, we only realized this week that we have not yet received our 2023 annual batch for our prescription strength antibiotic ointment packaged in sachets. All previous 2023 batches of this product were shipped, but fortunately the plant is just completing the last 2023 production batch. The problem is this last batch is not scheduled to be packaged till January 2024—5 months away. Even worse, this material has a 15-month expiry for a reason—it can’t make it to 18-months without an OOS.
We target 30 days from manufacture for stability enrollment, so we met with plant QA and planners to try and speed things up. We got no mercy—the January date is budget related, and since our 30-day enrollment is only a “target” and not a procedural requirement we had zero clout. They would not budge. So, we will be changing our procedure to make 30-day stability enrollment a requirement, but what do we do about this batch in the meantime?
How should this be resolved?
Here are some options we’ve identified:
A. Start the study from the date of manufacture in spite of the 5-months spent in bulk. Write a deviation to document this as well as account for the missed 3-month interval. B. Start the study from date in chamber, insert an expiry interval (as normal) but write a planned deviation to account for the expected OOS for intervals beyond expiry. C. Pull a previous batch from the field to enroll. One batch manufactured three months ago has sufficient inventory at the distribution center in Brazil.
What would you recommend? Do you have another option that’s even better?
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!
