記録された日時: July 23 2020
Safe manufacture and supply of pharmaceutical products requires companies to ensure that patient exposure to toxic elements such as lead (Pb), mercury (Hg), arsenic (As) and cadmium (Cd) is controlled to within safe limits as part of their drug dosing regimens. In response to this need, the International Conference on Harmonization (ICH) issued guidance in ICH Q3D regarding the acceptable exposure limits for 24 potentially toxic elements within drug products designed for oral, parenteral and inhaled administration. Compendial guidance, such that that provided in United States Pharmacopeia (USP) chapters <232>and <233>, supports ICH Q3D and provides additional direction regarding the measurement procedures which can be applied to assess the presence and concentration of elemental impurities. Since 2018, it has been a requirement for all pharmaceutical companies supplying to the US market to comply with USP <232>and USP <233>.
This webinar will be presented by Nancy Lewen, a recognized expert in element analysis who, over the past 15 years, has worked within with pharmaceutical industry and with groups considering methods standardization to understand how the requirements for elemental impurity detection can be realized. Nancy will explore the harmonization of USP <232>and ICH Q3D, along with the different analytical methods which can be used to measure elemental impurities in pharmaceutical products, intermediates and raw materials as described in USP <233>. Nancy will share her experience of following the ICH and USP requirements, including approaches for assessing the capability and application of the different elemental analysis methodologies. In particular, she will investigate the use of X-Ray Fluorescence (XRF), as compared to ICP and ICP-MS, focusing on its limitations and advantages for different drug products.