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Manufacture Standards & Regulation, Analytical Science, Quality & Compliance

Testing the Boundaries

In June 2016, the FDA announced new draft guidance on reducing elemental impurities in drug products. Elemental impurities can make their way into a drug product from various points in manufacturing processes – and in some cases can be a risk to patients. The aim of the guidance is to help manufacturers of both new and generic small-molecule drugs to comply with recent standards introduced by the International Council for Harmonization (ICH) and US Pharmacopeial Convention (USP). These standards, which are established in USP General Chapters <232> Elemental Impurities – Limits, and <233> Elemental Impurities – Procedures, as well as ICH Q3D – Guideline for Elemental Impurities, come into full effect at the start of 2018 and place drug elemental impurities into various new hazard categories based on their toxicity (permitted daily exposure [PDE]) and likelihood of occurrence in the drug product, which is derived from a number of factors including probability of use in pharmaceutical processes, probability of being a co-isolated impurity with other elemental impurities in materials used in pharmaceutical processes, and the observed natural abundance of the element.

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About the Author

Sarah James

Sarah James is Principal Scientist, CMC Analytical Services at LGC, UK.

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