Nitrosamine Episode Could Lead To Paradigm Shift In Quality

Just How Well Do Companies Know Their Products?

10 Oct 2019

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

Logistics and transportation of Container Cargo ship and Cargo plane with working crane bridge in shipyard at sunrise, logistic import export and transport industry background - Image — The Nitrosamine Issue Has Its Roots In The Global Supply Chain • Source: Shutterstock

The discovery of carcinogenic nitrosamine impurities in certain well-established antacid and blood pressure medicines implies that drug companies do not fully understand their products. Incidents such as these should serve as a wake-up call for regulators to review their age-old models for quality evaluation and result in a paradigm shift in how drug impurities are qualified.

These were the conclusions of a discussion at a recent industry conference in a session on establishing Europe as a...