How would a Judge decide in his Chambers?
All Situation Room examples are constructed and not descriptions of actual events.
Published on: March 2, 2025
Walter Routh
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What is the stability situation?
Our company is doing well with a pipeline of new products producing a couple of new candidates per year and our industry partner sends us a project every now and then. Our chambers are currently running at 80% capacity. We’re being careful to quickly purge completed studies, but it’s clear that we have to make some decisions right now or find our chambers overrun with incoming samples, possibly even by early next year.
Our budgets are locked in a year in advance and a chamber purchase is not in the latest round. Our organization does have a relationship with a CRO, and they offer Stability storage as a service, but our Quality folks have yet to include this aspect in their quality and service agreements or include it in a site audit. The jury is out on what we should do next.
How should this be resolved?
After some deliberation, we have a few options:
- Ask for emergency funding and risk our reputation as a responsible group by not having planned well.
- Get our chamber(s) on the list in the upcoming budget planning cycle.
- Request a Quality Audit of our CRO’s stability storage facility and program and add funding to the first available budget cycle.
- Maybe some other creative avenue that hasn’t come to mind so far.
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!
