FDA Issues Final Elemental Impurities Guidance

FDA published the final Q3D Elemental Impuritiesguidance on Sept. 9, 2015. The guidance was developed by the Quality Expert Working Group of the International Conference on Harmonization (ICH). The guidance outlines a process for assessing and controlling elemental impurities in drug products by using risk management, including a platform for developing a risk-based control strategy to limit elemental impurities.

The guidance applies to new finished drug products and new drug products that contain existing drug products (i.e., products containing purified proteins and polypeptides, their derivatives, and products of which they are components, and drug products containing synthetically produced polypeptides, polynucleotides, and oligosaccharides). Not covered in the guidance are herbal products, radiopharmaceuticals, vaccines, cell metabolites, DNA products, allergenic extracts, cells, whole blood, cellular blood components or blood derivatives, dialysate solutions not intended for systemic circulation, elements that are intentionally included in the drug product for therapeutic benefit, gene therapy products, cell therapy products, or tissue engineering products.

The guidance will go into effect for existing products 36 months after publication.

Source: FDA