Elemental impurities in drug products can arise from multiple sources, such as raw materials, excipients, manufacturing equipment and container closure/delivery systems. Risk-based approaches for controlling elemental impurities include specific elements to be considered from any source.
In December 2017 existing drug products in Europe will be required to comply with ICH Q3D Guidelines for Elemental Impurities. Per U.S. Food and Drug Administration (FDA) draft guidance Elemental Impurities in Drug Products, USP <232>/<233> will be applicable to all drug products with USP monographs on January 1, 2018.
Are you ready for the change?
Limits for the various potential elemental impurities are provided in ICH Q3D and USP <232>. In addition to the limits provided, any potential interactions with drug products need to be considered from a product quality and product safety perspective.
Join West experts Diane Paskiet and Diego Zurbriggen on October 19 for a free webinar as they will discuss a comprehensive approach to elemental impurities, including:
- Potential sources of elemental impurities
- Toxicity thresholds and other safety considerations
- Correlations to drug product quality and safety
Ready or not, changes are coming – so join us on October 19 to ensure you’re ready to comply.