ICH Q3D Metal Impurity Risk Assessments Pose Challenges
This article was originally published in The Gold Sheet
Pharmaceutical manufacturers say there is a lack of clarity in the recently published ICH Q3D guideline on risk assessments for metal impurities, which may potentially complicate implementation.
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Regulatory members of the International Council on Harmonization have issued Q3D guidance on metal impurities that, while harmonized, differs in emphasis.
One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”
High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.