FDA: unresolved CGMP problems can trigger bioequivalence studies for API-source changes
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.
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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.
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