Excipient Database Should Help Take Mystery Out Of ICH Q3D 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.
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More manufacturers are contributing their analytical data to an excipient database to pool knowledge on the risk posed by excipients that may cause drugs to exceed acceptable PDE levels under ICH Q3D.
While leveraging published data may help pharmaceutical manufacturers understand the general risks of using excipients with known elemental impurities, it is less helpful in understanding specific risks.
Regulatory members of the International Council on Harmonization have issued Q3D guidance on metal impurities that, while harmonized, differs in emphasis.