Nitrosamine Issue Presages Paradigm Shift In Quality

Just How Well Do Companies Know Their Products?

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.

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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...

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