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Panelists: impurity controls in intermediates can render primary DMFs inadequate
Summary
Speakers said even when a secondary DMF appears adequate, failure to control impurities in the primary manufacturing steps can make the primary DMF inadequate; reviewers frequently cite impurity profiles as top deficiencies.
Panelists cautioned that adequate documentation in a secondary DMF does not automatically mean the primary DMF will be considered adequate if the primary applicant's manufacturing process does not demonstrate control of impurities. "Even though secondary DMF adequate, we had to make the primary DMF inadequate because of the not addressing the control of impurities," one panelist said, describing a situation where control measures were addressed only later in synthesis.
The group flagged impurity assessment as a frequent source of review deficiencies. One panelist summarized the recurring problem: "We're at a point now where you don't just look at it and guess which ones are genotoxic. We are kind of expecting a hazard assessment so that you're classifying them appropriately per ICHM 7." The panel recommended applicants include hazard assessments and clear justifications for impurity limits in submissions.
