Regulatory Acceptance of Risk-Based Control Strategies for ICH Q3D: Using Shared Elemental Impurities Data for Risk Assessments
ICH Q3D advocates the use of a risk-based approach to the assessment of the risk posed by elemental impurities in drug products. The Elemental Impurities project is a collaborative data-sharing project which aims to facilitate more scientifically driven risk assessments under ICH Q3D.
During this webinar, Senior Scientist Grace Kocks, the lead scientist on the project at Lhasa, introduced the elemental impurities excipient data sharing initiative and consortium.
Then our guest speaker Craig Havenhand, Investigator at GSK, presented a brief overview of ICH Q3D and provided example risk assessments which use the elemental impurities excipient database in recent marketing applications and the resulting regulatory feedback.