The Quality Lowdown: More Concerns Raised About API Plants, Data Integrity And Sterility Assurance
Recent enforcement activities shed light on compliance challenges at ALI, UCB, Novo, Samsung, Nectar, Panacea and Beximco.
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Reorganization in January expected to leave CDER’s nine-year-old pharmaceutical quality assessment organization more adaptable to public health emergencies, new pharmaceutical technologies and market dynamics, while further blending approaches to new and generic drug reviews.
Stakeholders propose centralized oversight approaches for managing quality of “like-for-like” fleets of self-contained manufacturing units that could roam the US – or the world. The US FDA shares the industry’s thinking on how best to adapt the site-focused regulatory scheme it enforces to the emerging variety of distributed manufacturing systems.
US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.