Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium

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 m...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2015-03, Vol.104 (3), p.803
Main Authors: 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, Nasr, Moheb, Randolph, William, Robert, Jean-Louis, Rudd, Dave, Zezza, Diane
Format: Article
Language:English
Online Access:Get full text
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Summary: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. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.
ISSN:1520-6017
DOI:10.1002/jps.24324