Statistical Tools for Setting In-Process Acceptance Criteria

Publication
Article
BioPharm InternationalBioPharm 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.

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Recent Videos
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Mike Schaefers Simtra BioPharma Solutions, Shiva Khalafpour MilliporeSigma, the Life Science Business of Merck KGaA, Darmstadt, Germany
Chris Hagan, SCIEX
Daniel Fischer, Tevard
Junevity Co-founder & CEO, John Hoekman, PhD
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Related Content
© 2025 MJH Life Sciences

All rights reserved.