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Title Innovations in pharmaceutical manufacturing on the horizon : technical challenges, regulatory issues, and recommendations / Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing; Board on Chemical Sciences and Technology; Division on Earth and Life Studies; the National Academies of Sciences, Engineering, Medicine.

Publication Info. Washington, DC : National Academies Press, [2021]

Item Status

Description 1 online resource (1 PDF file (x, 110 pages)) : illustrations.
Physical Medium polychrome
Description text file
Series Consensus study report of the National Academies of Sciences, Engineering, Medicine
Consensus study report.
Bibliography Includes bibliographical references.
Summary In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further. At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies -- such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years.
Funding This project was supported by Contract 75F40119C10045 between the National Academies of Sciences, Engineering, and Medicine and the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
Contents Front Matter -- Summary -- 1. Introduction -- 2. Innovations in manufacturing drug substances -- 3 Innovations in manufacturing drug products -- 4. New control approaches to enable quality assurance and process capability -- 5. Innovations in integrated, flexible, and distributed manufacturing networks -- 6. Advancing innovation: observations, challenges, opportunities, and recommendations -- Appendix A: Biographic information on the Committee to Identify Innovative Technologies to Advances Pharmaceutical Manufacturing -- Appendix B: Disclosure of unavoidable conflicts of interest -- Appendix C: Workshop and webinar agenda -- Appendix D: Innovations in pharmaceutical manufacturing proceeding of a workshop - in brief -- Appendix E: Barriers to innovations in pharmaceutical manufacturing proceedings of a workshop - in brief.
Local Note eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject Pharmaceutical microbiology -- Methodology.
Pharmaceutical microbiology.
Methodology.
Quality control.
Quality control.
United States.
quality control.
Genre/Form Electronic books.
Electronic books.
Added Author National Academies of Sciences, Engineering, and Medicine (U.S.). Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing, issuing body.
Other Form: Print version: Innovations in pharmaceutical manufacturing on the horizon. Washington, D.C. : National Academies Press, 2021 9780309088671 (OCoLC)1250021153
ISBN 9780309088671
0309088674
9780309104982 (electronic book)
030910498X (electronic book)
9780309104807
0309104807