GDF2026 - Q&A Discussion Panel Six

Agency technical Q&A (organizer not specified) · July 30, 2026

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9:43

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9:43

Industry question on number of lots used in microbiology testing

PresentationDiscussion

0:02 → 0:46(45s)

Aloka Srinivasan (Raha LLC) asked why reviewers are seeing too few production lots used in microbiology-related submissions, noting that when she worked at FDA the standard was three lots. She asked whether the practice has changed or whether applicants are skipping appropriate testing.

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Technical agency Q&A where industry representatives asked agency doctors about microbiology testing practices (lot replicates), sterilization options and SAL, bioequivalence meeting eligibility amid RLD shortages, preservative testing and antioxidants, cohort sampling for transdermal systems, and subject-period reanalysis. The session paused for lunch after audience questions.

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