Japanese–English glossary
Continuous manufacturing
連続生産renzoku seisan
Also written 連続・コネクテッド生産、コンティニュアス・マニュファクチャリング
A production mode in which material is fed into and removed from the process continuously, with unit operations connected, instead of being processed in separate batches. ICH Q13 covers the scientific and regulatory considerations, including how a batch is defined, material traceability and residence time distribution. For biologics it can mean perfusion culture linked to continuous capture and downstream steps. Japanese documents use the term for both small-molecule and biologic processes. Settle early with the reviewer how a lot is defined in the application and how the control strategy handles disturbances and diverted material.