31 August 2016

The Q3D Training Modules 8-9 (Module 8: Case Studies; Modules 9: FAQ document) can now be found on the ICH website. The Q3D Guideline aims to provide a global policy for limiting elemental impurities in drug products. The development of a comprehensive training programme and supporting documentation was considered necessary by ICH, to ensure the proper interpretation and effective utilisation of the Q3D Guideline by industry and regulators alike, to enable a harmonised and smooth implementation of Q3D on a global basis.

The Q3D Training Modules 8-9 are now available for download on the ICH website under Quality Guideline/Q3D.