470871 Regulatory Approach for Supporting Emerging Pharmaceutical Technology

Monday, November 14, 2016: 9:30 AM
Continental 5 (Hilton San Francisco Union Square)
Rapti Madurawe, CDER/OPS/ONDQA, FDA, Silver Spring, MD and Sau Lee, Immediate Office, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD

Office of Pharmaceutical Quality (OPQ) supports modernization of pharmaceutical development and manufacturing. Therefore, OPQ encourages the adoption emerging pharmaceutical technology that has potential to enhance the process capability and therefore product quality. Emerging technology may include novel process and product designs, as well as innovative analytical technology. Examples of emerging technology are continuous manufacturing and 3-D printing technologies. Because emerging technologies, by definition, will generally be unfamiliar, in both industrial and regulatory contexts, OPQ established the Emerging Technology Team (ETT) to facilitate the identification and implementation of emerging technology in at least three ways. 1) by enhancing communication among sponsors, manufacturers, and regulators, both early in the engagement of emerging technology design and development and at appropriate later time points (including the course of regulatory review); 2) by leading or otherwise supporting the quality assessment team, in partnership with relevant OPQ offices, in regulatory reviews; and 3) by documenting ETT/OPQ resolutions to scientific and policy issues that may inform FDA approaches to the review and implementation of emerging technologies. Furthermore, OPQ have initiated a regulatory science program to enhance the agency’s knowledge in the emerging technology area. For example, OPQ initiated several research projects in continuous pharmaceutical manufacturing, including the development of integrated process models similar to the approaches utilized by the chemical industry; the development of a database of excipient properties to capture the behavior of common raw materials within different processing environments, the standardization of processing equipment integration components to increase flexibility; and the advancement of automatic process control systems.

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