Points to Consider in Continuous Manufacturing of Injections

Abstract

Continuous manufacturing (CM) involves the continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process. Although the ICH Q13 guideline that describes scientific approaches and regulatory considerations specific to CM has been issued, additional information about injections must be provided. Therefore, to promote the application of CM to injections, a Japan Agency for Medical Research and Development (AMED) research group, consisting of members from industry, academia, and the regulatory authorities, was set up to examine CM model cases for injections and establish control strategies and other technical considerations and summarize them as a Points to Consider document. This paper presents the points to consider in CM of injections which are model cases of terminal sterilization or aseptic processing, and lyophilized drug products.