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

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:
Pharmaceutical industry > Capital productivity > United States.
Pharmaceutical industry > Production control > United States.
Pharmaceutical industry > Production standards > United States.
Pharmaceutical technology > United States.
Industrie pharmaceutique > Productivité du capital > États-Unis.
Industrie pharmaceutique > Production > Contrôle > États-Unis.
Industrie pharmaceutique > Production > Normes > États-Unis.
Techniques pharmaceutiques > États-Unis.
Pharmaceutical industry > Capital productivity.
Pharmaceutical industry > Production control.
Pharmaceutical technology.
United States.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009816702306719
Tabla de Contenidos:
  • 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

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