By Cambrex

Published in: Pharmaceutical OnLine

Published on: January 14, 2025

A pharmaceutical company was conducting stability testing on a new drug product intended to treat a rare, life-threatening disease. The product was in the final stage of development and on track to be submitted for regulatory approval. At one point in their ICH stability study, the company discovered that one of its stability chambers had malfunctioned due to a faulty sensor that caused the temperature and humidity levels to fluctuate erratically. The malfunction continued unnoticed for several hours, affecting hundreds of samples. The pharmaceutical company was unable to leverage its own in-house backup equipment, as all redundant chambers were already at full capacity. The pharmaceutical company faced the risk of losing valuable data and samples, delaying its regulatory filing, and compromising its product quality and patient safety.

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