Panelists: impurity controls in intermediates can render primary DMFs inadequate
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.
The full story
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.
Sign up to keep reading.
Your free newsletter brings you what your city council, county, and school board discussed and decided.