When submitting drug products for approval, regulatory authorities frequently ask, “Are you submitting your risk assessment for potential elemental impurities as well?” Addressing this critical aspect, our upcoming webinar will focus on managing the risk assessment for potential elemental impurities in both drug products and medical devices.
The United States Pharmacopeia (USP), in collaboration with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), has established standards for measuring inorganic impurities in pharmaceuticals and their ingredients. These standards are outlined in USP General Chapters 232 (Elemental Impurities – Limits) and 233 (Elemental Impurities – Procedures), which have been in effect since January 2018. The equivalent ICH method is detailed in the Guideline for Elemental Impurities (Q3D), with its Revision 1 adopted in March 2019.
Both the ICH Q3D guideline and USP 232 chapters address catalyst elements and other inorganic contaminants that may enter a drug product through raw materials, manufacturing processes, the environment, packaging, and container closure systems (CCS). The maximum exposure limits for these impurities are determined based on their toxicity and route of exposure.
In this webinar, participants will gain a comprehensive understanding of risk assessment for potential elemental impurities. Key topics will include:
- The concept of risk assessment for potential elemental impurities, explaining the regulatory expectations and the importance of this assessment in ensuring product safety.
- Detailed insights into how potential elemental impurities in drug products and medical devices are regulated, highlighting the differences and similarities in global regulatory requirements.
- Expert guidance on developing methodologies for assessing elemental impurities using techniques such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS).
By attending this webinar, you will be equipped with the knowledge and tools to effectively manage and mitigate the risks associated with elemental impurities, ensuring compliance with regulatory standards and safeguarding patient safety.