Specification-driven acceptance criteria for validation of biopharmaceutical processes

Intermediate acceptance criteria are the foundation for developing control strategies in process validation stage 1 in the pharmaceutical industry. At drug substance or product level such intermediate acceptance criteria for quality are available and referred to as specification limits. However, it...

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Bibliographic Details

Published in:	Frontiers in Bioengineering and Biotechnology
Main Authors:	Lukas Marschall, Christopher Taylor, Thomas Zahel, Marco Kunzelmann, Alexander Wiedenmann, Beate Presser, Joey Studts, Christoph Herwig
Format:	Article
Language:	English
Published:	Frontiers Media S.A. 2022-09-01
Subjects:	integrated process model statistical modelling bioprocess control strategy acceptance criteria specification limits
Online Access:	https://www.frontiersin.org/articles/10.3389/fbioe.2022.1010583/full