Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals

Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Cont...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2017-11, Vol.106 (11), p.3199-3206
Main Authors: Nasr, Moheb M., Krumme, Markus, Matsuda, Yoshihiro, Trout, Bernhardt L., Badman, Clive, Mascia, Salvatore, Cooney, Charles L., Jensen, Keith D., Florence, Alastair, Johnston, Craig, Konstantinov, Konstantin, Lee, Sau L.
Format: Article
Language:English
Subjects:
continuous manufacturing
control strategy
Drug and Narcotic Control - methods
Drug Industry - methods
Humans
ICH
ISCMP
Massachusetts
PAT
process monitoring
process validation
Quality Control
real-time release
regulatory considerations
Risk Assessment
Technology, Pharmaceutical - methods
traceability
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Summary:Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2017.06.015