ICH Q3D Metal Impurities Guidance Issued By FDA, EMA, Health Canada
Regulatory members of the International Council on Harmonization have issued Q3D guidance on metal impurities that, while harmonized, differs in emphasis.
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Pharmaceutical manufacturers say that complying with ICH Q3D presents a host of challenges, and that the more difficult task is conducting a risk assessment rather than actual testing for elemental impurities. Companies are finding that they should allow plenty of time for risk assessments.
The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.
Drug makers working to comply with new ICH Q3D metal impurity standards should pay special attention to the possibility of metals leaching from manufacturing equipment and container closures, an FDA official says at agency workshop.