Innovations in Pharmaceutical Manufacturing on the Horizon Technical Challenges, Regulatory Issues, and Recommendations

"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 manufac...

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Detalles Bibliográficos
Autor principal: National Academies of Sciences, Engineering, and Medicine (-)
Otros Autores: Studies, Division on Earth and Life, Technology, Board on Chemical Sciences and, Manufacturing, Committee to Identify Innovative Technologies to Advance Pharmaceutical
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press 2021.
Materias:
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009816702306719
Descripción
Sumario:"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." --
Descripción Física:1 online resource (121 pages)
ISBN:9780309104982
9780309104807