Interview with Paulino Alonso: ICHQ3D on Elemental impurities

ICHQ3D implementation involves a risk analysis to design strategies to control elemental impurities in drugs for human use, accountability for which lies fully with the owners of the marketing authorisation. The deadline to implement this guideline for elemental impurities expires at the end of 2017.   In this interview, Paulino Alonso, Azierta’s Toxicology team responsible…

Key factors for the implementation of directive ICH Q3D on elemental impurities

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines. There are 4 issues to be taken into account before starting the risk analysis:   The strategies that we follow will largely depend on the suppliers’ baseline information. The number of products requiring risk analysis, which will also…