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Panelist: reviewers typically expect triplicate lot testing in microbiology studies
Summary
Industry representative Aloka Srinivasan asked why some submissions use too few production lots for microbiology testing; Dr. Chen said reviewers typically expect triplicate testing and many review issues stem from failures to provide triplicates.
Aloka Srinivasan, of Raha LLC, asked agency panelists why reviewers are seeing too few production lots used in microbiology-related submissions, saying that "as a former FDA, it was the holy trinity" and that three lots used to be the accepted practice.
Dr. Chen replied that reviewers "typically, we always want to see things in triplicates," and that many of the review issues the panel sees are related to failures in triplicate testing. The panelist recommended that applicants follow triplicate or equivalent sampling strategies and prepare supporting data and rationales when deviating from that approach.
The exchange occurred during an audience Q&A and did not result in any formal agency action during the session. The panel discussed that deviations from triplicate testing often trigger questions during review and that applicants should address lot selection, statistical approach, and justifications in their submissions.
