Regulators Find Room For ICH Q3D Metal Impurity Risk Assessments To Improve
FDA Says Submissions Rarely Rejected Due to Poor Quality Risk Assessments
The pharmaceutical industry is doing a better job of conducting the risk assessments called for in the ICH Q3D elemental impurity limits guideline, and regulators are not rejecting applications because of poor quality assessments, yet regulators say there is still room for improvement.
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Excipient suppliers complain about agency requests for elemental impurities data that go beyond ICH and USP requirements and delay approvals.
ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.
The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.