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Regulatory and Quality Considerations for Continuous Manufacturing

By Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Nasr, Moheb; Zezza, Diane

Published on

Abstract

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.

Journal

Journal of Pharmaceutical Sciences. Volume 104, 2015, 803-812

DOI

10.1002/jps.24324

Type of publication

Peer-reviewed journal

Affiliations

  • Pfizer Inc
  • Novartis Pharma
  • Massachusetts Institute of Technology (MIT) (MIT), FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), Roche, GlaxoSmithKline, Vertex, AstraZeneca, Jansen, Norwegian Medicines Agency, Luxembourg National Health Laboratory

Article Classification

Research article

Classification Areas

  • PAT
  • Regulatory

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