Guideline On Elemental Impurities: Challenges And Approaches For Implementation

Presenter: Dr. Ulrich Reichert, Regulatory Management, Life Science, MilliporeSigma

In June 2016, the ICH Q3D guideline on elemental impurities will become effective for new drug products. Elemental impurities may arise from elements that have been added intentionally, or that may be present as contaminants. The guideline has a huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide.

This webinar provides an overview of the current and upcoming regulatory requirements for elemental impurities, including recent developments in the pharmacopoeias (Ph. Eur. and USP). We will discuss their impact on drug product and pharmaceutical starting materials, focusing on APIs and excipients. The presentation will also outline risk-based approaches to assess and implement control strategies for elemental impurities, based on the latest regulatory requirements, and how this can be supported with dedicated documentation.