FDA publishes final guidance: Elemental Impurities in Drug Products

FDA has issued a final guidance entitled, Elemental Impurities in Drug Products.  The guidance finalizes a draft guidance document issued July 1, 2016.  On January 1, 2018, the International Council for Harmonisation’s (ICH) Q3D Elemental Impurities guideline went into effect, along with United States Pharmacopeia General Chapters < 232 > and < 233 > regarding the control of elemental impurities in drug products.  The final guidance provides recommendations for controlling elemental impurities consistent with the ICH Q3D guideline and USP requirements.

Elemental impurities, including heavy metals, pose serious risks to patients without providing a benefit. Modern methods provide better analytical tests to detect elemental impurities, which in turn, will help protect patients by ensuring approved products have acceptable levels of these impurities.  FDA, ICH, USP, and industry experts worked together to develop the new standards that are in alignment and help ensure high quality medicines.  These efforts replace outdated tests with modern analytical capabilities that allow more precise measurements of impurities to ensure safe levels.  For additional background information, visit FDA’s elemental impurities webpage.