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Presenter cautions that retention-time region–based control strategies may be inadequate for generics
Summary
The presenter warned that retention-time region–based control strategies adopted by RLDs may not be directly comparable for generic applicants and could increase risk for generics unless supplemented by additional controls, qualifications, or certifications.
The presenter warned that a retention-time region–based control strategy (grouping by retention time) used by an innovative product may not be adequate for a generic without further controls or qualification because internal methods can differ. "Lastly, I'd like to point out that retention time reason based control strategy, or similar grouping approach may not be adequate for genetic oligonucleotide without further controls or, you know, proper, certification or qualification," he said.
The presenter added that if RLDs use such strategies, generics cannot directly compare retention-time–region criteria unless the underlying methods are comparable; new or higher-level impurities, coelution, and differences in method sensitivity raise the risk for generics adopting an RLD's retention-time approach. He recommended documenting additional controls and providing method-qualification evidence when relying on retention-time grouping.
