Statistical Tools for Setting In-Process Acceptance Criteria

Seely,Robert;Louis Munyakazi;John Haury;

Publication

Article

October 15, 2001

BioPharm International

BioPharm International-10-01-2001

Volume14

Issue 10

Statistical Tools for Setting In-Process Acceptance Criteria

Author(s):

Robert J. Seely,Louis Munyakazi

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.

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Statistical Tools for Setting In-Process Acceptance Criteria

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