PMDA: Continuous Manufacturing
In July 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) established the Innovative Manufacturing Technology Working Group (IMT-WG) as part of the “Projects Across Multi-Offices” in PMDA. The IMT-WG launched activities to examine desirable regulations that streamline the introduction of new manufacturing technologies, and selected continuous manufacturing as their primary target.
The document “PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry” of 30th March 2018 includes some views on applying continuous manufacturing to pharmaceutical products at this time point, which are compiled within the limited practical experience that the IMT-WG has.
Document: PMDA Views on Applying Continuous Manufacturing