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FDA: unresolved CGMP problems can trigger bioequivalence studies for API-source changes
Summary
Agency staff said a hypothetical requiring a new bioequivalence (BE) study for a change in API source was driven by unresolved CGMP deficiencies that undermined batch quality; if CGMP issues were resolved, dissolution data might have sufficed.
An online question asked why a new bioequivalence study was necessary when the concern appeared limited to nitrosamine toxicology rather than pharmacokinetics. An agency official explained that the case study included CGMP deficiencies and that when batch quality cannot be assured because of unaddressed CGMP problems, dissolution data alone are insufficient and a BE study may be required.
"Because they never addressed those deficiencies, then the quality of the batches could not be assured. So that's why in that case, the dissolution data only was not enough," the official said, adding that if CGMP issues had been resolved and batch quality assured, dissolution data would typically be sufficient for an API source change.
