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.
Table of 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 Advance Pharmaceutical Manufacturing Appendix B: Disclosure of Unavoidable Conflicts of Interest Appendix C: Workshop and Webinar Agendas Appendix D: Innovations in Pharmaceutical Manufacturing Proceeding of a Workshopin Brief Appendix E: Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshopin Brief
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