Elemental Impurities Emerge As New Compliance Challenge

After almost 20 years of discussion, the FDA issued new guidelines in 2018 for controlling and measuring the risk of contamination within pharmaceutical products due to the presence of heavy metals.

The agency issued guidance in August 2018 regarding the control of elemental impurities of human drug products. The guidance is consistent with implementation of International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities (ICH Q3D), the FDA says.

At a minimum, drug manufacturers must consider common heavy metals such as arsenic, cadmium, lead, and mercury in risk assessments, the FDA said when announcing the standards.

Despite advanced notice, capacity and capabilities remain limited. Partnering with an experienced provider will help you manage the risk of elemental impurities as more standards appear in coming years.