Where Can I Find Information About…?

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

Published on: May 5, 2024
Walter Routh
Categories: The Situation Room
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What is the stability situation?

We have a debate heating up between the Stability Manager and R&D QA management. The Stability Manager runs the day-to-day logistics of our program including chamber maintenance, sampling, data analysis and reporting—they often host audit tours. R&D QA management on the other hand writes stability protocols and sends them and the associated samples to the stability group for implementation. R&D QA ultimately submits the data for regulatory review and deals with deficiencies—they also hold the financial burden for the studies.

With that in mind, money is at the core of the debate. Running a stability study for a new drug that likely won’t make it to the market will require hundreds of thousands of Euros to complete if it is performed under strict GMP conditions, both for storage and testing. Running it like an early stage 1 exploratory study will require fewer batches, enable reduced testing and potentially about 30% of the cost.

The Stability manager doesn’t want to risk an observation from an auditor questioning non-GMP studies in the chamber, but R&D QA is willing to take the risk that these materials won’t be filed and thus won’t come under GMP scrutiny anyway. Where would you recommend we go to find the appropriate stability information regarding which route to take for these stability studies?

How should this be resolved?

Have you visited StabilityHub lately? This month we're looking for people to give their long form answers and tell us how they would search for this information regarding GMP stability requirements for stage 1 or 2 materials in the EU.

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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!