Manufacturing flexibility to provide rapid response for changes in market demand has been a major industry driver for the adoption of new pharmaceutical manufacturing technologies, such as continuous manufacturing and portable on demand manufacturing (PODs). With the assistance of specialized support groups within the US FDA and other regulatory agencies, significant progress has been made in commercial advancement for some of these technologies. However, regulatory gaps remain both for worldwide implementation of today’s technologies and for those on the horizon.
With the advent of the COVID pandemic, the need has never been greater for rapid and flexible manufacturing. Many regulatory agencies have responded with unprecedented flexibilities for manufacturing GMPs and for regulatory submissions. This presentation will examine the current landscape both for new technology and for regulatory flexibility and discuss how these two trends could converge to accelerate widescale adoption of innovative pharmaceutical manufacturing.
Discuss several emerging pharmaceutical manufacturing technologies and approaches
Explore what are actual vs perceived regulatory barriers to implementation of new pharmaceutical manufacturing technology
Understand how to approach regulators in US, Europe and Japan for discussion on new technology