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

Thomas F O'Connor1, Sharmista Chatterjee1, Johnny Lam2

  • 1Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.

International Journal of Pharmaceutics: X
|August 29, 2024
PubMed
Summary

Process models enhance pharmaceutical manufacturing, with AI accelerating development. This work reviews risk frameworks for validating and maintaining these models throughout the product lifecycle.

Keywords:
Model lifecycle maintenanceModel risk assessmentModel validationPharmaceuticalsProcess models

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