Traditionally, pharmaceutical manufacturers have used batch processing. This approach features a series of distinct steps, between which activity stops. In contrast, continuous manufacturing is an uninterrupted process that converts raw materials into finished products. Regulators, including the US Food and Drug Administration, have argued continuous manufacturing is faster, more reliable and safer, contributing to a gradual increase in adoption. Now, PMDA is doing its bit to move things along. The draft document published by the agency lays out how to design a control strategy, validate process performance and perform stability tests that enable the adoption of continuous manufacturing. Publication of the document marks the culmination of nearly two years of work by Yoshihiro Matsuda and other PMDA scientists involved in the agency’s Innovative Manufacturing Technology Working Group. Over that time, PMDA officials have met with their counterparts in the US and Europe and discussed continuous manufacturing with industry and academia. The result is a text intended to further PMDA’s policy of encouraging companies to introduce innovative production technologies. More Information On RAPS