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PSG guidance emphasizes lot testing and supportive characterization for comparability
Summary
The presenter recommended testing multiple lots (ideally three) of reference and test products to establish comparability ranges, noted practical availability constraints, and said firms should provide scientific explanations for observed differences.
The presenter advised applicants to test multiple production lots to support comparability claims: “So generally, we do recommend 3 lots of both the reference standard or and the test products to be tested, because this really gives the data to allow establishment of a range for comparability purpose.”
He acknowledged the frequent practical challenge of limited availability of reference lots and said fewer than three lots can be acceptable if applicants provide supporting evidence and scientific explanation for any observed differences. The presenter urged applicants to continue efforts to obtain additional lots when possible and to use in vivo or other characterization data to explain discrepancies.
