Manufacturers Should Generate Own Elemental Impurity Data To Comply With ICH Q3D
Executive Summary
Manufacturers should create internal databases on elemental impurities for product risk assessments and not depend on suppliers to provide this information, which is called for under ICH Q3D. So far risk assessments have shown that most products are significantly below elemental impurity thresholds. Pharmaceutical manufacturers must complete assessments of legacy drugs by Dec. 31.
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