FDA Perspective and Expectations for Control of Elemental Impurities in Drug Products

Link to presentation by D. Christodoulou (CDER/OPQ Office of New Drug Products) on the PQRI website as part of the USP Elemental Impurities Workshop (November 2016)

This presentation discusses FDA’s approach to consideration of critical factors in controlling elemental impurities: timelines, documentation, GMP expectations and methods validation.

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