Drug Manufacturers, Technology, Therapy Area

An Overview of the ICH-Q3D Heavy Metal Regulations

By SiliCycle

The presence of residual metal impurities during drug manufacturing has become a major issue in the pharmaceutical industry in recent years, prompting a wide amount of interest in solutions for their safe and efficient removal.

For almost two years now, the International Conference on Harmonisation (ICH) has been working on its Q3D guidelines for metal elemental impurities in new drugs and new formulations containing known ingredients.

After many revisions and improvements, the final version or the Q3D guidelines was finally accepted and signed off by the ICH Steering Committee in December 2014, with the implementation phase following in January 2016.

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