Shaky Ground: Is It Still Good for 2 Years?

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

Published on: September 30, 2023
Walter Routh
Categories: The Situation Room
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What is the stability situation?

Our plant in Timbuktu manufacturing Phase 3 clinical material proposed a 2-year shelf-life for the product based on historical Phase 1 data generated nearly 4 years ago. At that time, four years ago, we had a smaller drug substance production scale and since then, some important process changes (new drying process, for example). Still, the fact is, the chromatographic impurity profiles are similar between our Phase 1 and Phase 3 product—it is the same formulation—and forced degradation studies also confirm comparability. But, does that comparability justify applying the same shelf-life?

Instead of generating current real-time data, we would like to avoid the 12-month delay and costly stability product runs prior to assigning the 2-year shelf-life. Timbuktu regulatory personnel recommend that we proceed with the 2-year dating and simply place portions of the first three Phase 3 batches on stability concurrent with the ongoing trials—just like post-approval studies. Quality personnel in Montezuma, on the other hand, are raising alarms as to the potential risks, especially pointing out that the Phase 1 material wasn’t extremely robust—it met specifications at 2 years but failed to meet them at 3 years.

What do you recommend as a path forward—we’d much prefer to use Phase 1 dating, so how could we accomplish that goal safely and quickly?

How should this be resolved?

Some possible solutions include:

- Take a chance and move forward without further study

- Add simultaneous studies to show due diligence

- Bite the bullet and wait for new data on which to base a shelf life

We Want to Hear Your Thoughts!

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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!