Abstract: The evaluation of elemental impurities in pharmaceutical excipients is a critical part of drug safety control. Based on the guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the quality risk management principles, an effective method for the risk assessment of elemental impurities in pharmaceutical excipients can be established using the ICH Q3D Elemental Impurities Guidelines. This approach is applicable to both the research and development and manufacturing of pharmaceutical excipients and drugs. This paper proposes a comprehensive risk management framework, which encompasses risk assessment, risk control, risk communication, and periodic risk review, by investigating the sources of elemental impurities in pharmaceutical excipients and their potential impact on drug safety. Through specific case studies, this paper reviews the practical methodologies for conducting risk assessment of elemental impurities in pharmaceutical excipients, with a prospect of the application of relevant risk management tools and the continuous improvement of the quality management of pharmaceutical excipients.