The introduction of new guidelines relating to elemental impurities in pharmaceuticals from the International Conference on Harmonization (ICH), U.S. Food and Drug Administration (FDA) and United States Pharmacopeia (USP) has created new and complex challenges for the pharmaceutical industry. These challenges include replacing the wet chemistry “heavy metals” limit test with new analytical technology, specifically, inductively coupled plasma (ICP) –based technologies and mandated conformance to new and specific limits for individual elements. From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product and the materials/processes involved.
Are you ready for this regulatory change?
The methods outlined in USP General Chapter <231> will be retired on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredient.
This webinar will address:
Chris Williams, Manager
Ashley Taylor, Senior Scientist