Japanese PMDA Perspectives on RMMs

Following the FDA presentations, Dr. Tsuguo Sasaki, Japanese PMDA, provided his views on the use of RMMs in Japan. The PMDA will work with companies in the development of RMM strategies for use in Japan. For example, in a number of cases, it may not be possible to detect microorganisms in stressed environments, such as purified water and RO test samples. Therefore, it is hoped that more rapid and continuous monitoring methods be developed for microorganism detection in pharmaceutical-grade water systems.

Regardless of the technology, the PMDA will follow a similar strategy for reviewing RMM validation submissions as the US FDA does.