Point Me in the Right Direction, Please
All Situation Room examples are constructed and not descriptions of actual events.
Published on: April 26, 2025
Jason Cavett
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What is the stability situation?
We’re just starting our three registration lots on stability and are adding three in-use studies for our new oral dose ACE Inhibitor. For in-use testing we’re opening bottles and removing product 30 times over 30 days with testing performed at the 15 and 30-day marks. The first two in-use studies are being stressed within the first six months of the batches’ shelf lives, but we’re not certain where to turn regarding the third batch. Per EMEA’s 2001 guidance on in use stability testing (CPMP/QWP/2934/99) at least one of the three batches needs to be tested “towards the end of its shelf life” but the same paragraph also notes that if you can’t do that, then test at the final point of the submitted stability studies.
We are divided here in QA and Stability management as to whether we’re supposed to begin the in-use portion at expiry and thus proceed beyond expiry or if the 30-day use period should actually begin 30 days before expiry so that the final bottle opening would occur on product expiry. We’ve searched for more clarity on this topic and are hoping that anyone can point us in the right direction for references that will help us better prepare for what the inspector would be looking for.
Can anyone recommend a repository for resources such as regulatory guidances, publications, presentations, webinars or actual experiences on this topic?
How should this be resolved?
Obviously StabilityHub is a wonderful source of stability information (check out The Hub for specific focus areas!), but we’d love to hear of other repositories in conjunction with our Stability Information Month theme.
We Want to Hear Your Thoughts!
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.
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.
Share your questions and experiences
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!
