Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices

When Drug Products were submitted for approval, Regulatory authorities ask the question, “Are you submitting your Risk Assessment for the Potential Elemental Impurities as well?”.
This webinar will address how to deal with “Risk Assessment for Potential Elemental Impurities” on Drug Products and Medical Devices. The USP, in parallel with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), has published standards for measuring inorganic impurities in pharmaceuticals and their ingredients. The USP General Chapters USP 232 (Elemental Impurities - Limits) and 233 (Elemental Impurities - Procedures) were implemented as of January 2018. The equivalent ICH method was defined in the Guideline for Elemental Impurities (Q3D) and Revision 1 was adopted on March, 2019. The ICH Q3D and USP 232 chapters include catalyst elements, and other inorganic contaminants that may enter a drug product from raw materials, the manufacturing process, the environment, packaging and container closure systems (CCS). The maximum exposure limits are defined according to each impurity's toxicity and route of exposure.
What you will learn in this webinar:
• Learn the concept of risk assessment for potential elemental impurities
• How Potential Elemental Impurities on Drug Products/Medical Devices are regulated.
• Get expert insights on how to develop methodologies regarding Elemental Impurities on Drug Products/Medical Devices via ICP-MS.

[@Mohammed-mw8wg]

Is it a risk assessment or equipment operation demonstration

[@sooksriungboriboonpisal1154]

Q : We have to add this test into finished product specification or not.