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A Risk-Based Digital Validation Workflow for Advanced Process Control in GMP-Regulated Manufacturing: A Model-Based Approach Demonstrated Through pH Control

Damian McCarthy; Dermot McMorrow; Amol Ganjare; Vivek Ranade; Conor T. McCarthy; Eoin P. Hinchy

Published
Publisher
Springer Science and Business Media LLC
Journal / collection
Journal of Pharmaceutical Innovation
Research area
Industrial systems
Source type
Journal article
DOI
10.1007/s12247-026-11080-1

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Damian McCarthy; Dermot McMorrow; Amol Ganjare; Vivek Ranade; Conor T. McCarthy; Eoin P. Hinchy. A Risk-Based Digital Validation Workflow for Advanced Process Control in GMP-Regulated Manufacturing: A Model-Based Approach Demonstrated Through pH Control. Journal of Pharmaceutical Innovation. 2026-10-03. https://doi.org/10.1007/s12247-026-11080-1

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