Statistical Tools for Setting In-Process Acceptance Criteria

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BioPharm International, BioPharm International-10-01-2001, Volume 14, Issue 10

by Robert J. Seely, Louis Munyakazi, and John Haury Regulatory approval and successful manufacturing depend on establishing meaningful and reasonable acceptance criteria for process validations and ongoing monitoring. Three methods are presented here to correct for the likely underestimation of process limits due to small samples.