An examination of process models and model risk frameworks for pharmaceutical manufacturing

An examination of process models and model risk frameworks for pharmaceutical manufacturing

Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes. Tools such as Artificial Intelligence (AI) might accelerate process development and allow...

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Bibliographic Details
Main Authors: Thomas F. O'Connor, Sharmista Chatterjee, Johnny Lam, Dolores Hernán Pérez de la Ossa, Leticia Martinez-Peyrat, Marcel H.N. Hoefnagel, Adam C. Fisher
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:International Journal of Pharmaceutics: X
Subjects:
Pharmaceuticals
Process models
Model risk assessment
Model validation
Model lifecycle maintenance
Online Access:http://www.sciencedirect.com/science/article/pii/S259015672400046X
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