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The Quality Lowdown: Risk And Opportunity

 
• By Bowman Cox

Recent developments confirm the laser focus of the US FDA and the pharmaceutical industry on managing quality risks such as potentially carcinogenic impurities, product mix-ups and microbial contamination. But they also underscored opportunities like global regulatory harmonization, assay development and responses to negative pre-approval inspections.

High jump

The discovery of a probable carcinogen in a widely used blood pressure medication has prompted a high-level response from the US FDA, reminiscent of past agency responses to major quality crises.

However, unlike the New England Compounding Center crisis in 2012 and the heparin active pharmaceutical ingredient adulteration crisis in 2008,...

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