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Presenter explains when secondary DMFs can be treated as starting materials versus intermediates
Summary
The presenter outlined criteria for treating secondary DMFs as starting materials (requiring ICH Q11 justification and cGMP facility compliance) versus intermediates (where some quality sections may be less critical), and noted primary DMF holders retain responsibility for impurity control.
The presenter said secondary DMFs may play different roles in a primary DMF’s manufacturing scheme and explained how that classification affects review. “If the secondary DMF is referenced as a starting material, it should be justified based on ICH Q11 guidance,” the presenter said.
When treated as a starting material, the presenter said the agency may not formally review the secondary DMF if most necessary information is already in the primary DMF; if information is missing, reviewers will examine the secondary DMF. When the secondary DMF is an intermediate, the presenter said many quality sections — including cGMP and facility information — will be critically evaluated but certain sections may be less applicable; nevertheless the primary DMF holder must ensure an overall impurity-control strategy, including supportive spike‑and‑batch data where upstream impurity levels warrant.
