Overview of ICH Q13 Guideline for Continuous Manufacturing of Drug Substances and Drug Products

Abstract

 Continuous manufacturing attracted attention as an innovative manufacturing technology contributing to the stable supply of pharmaceutical products, and development of an internationally harmonized guideline for the implementation of continuous manufacturing was desired. ICH adopted a topic on the continuous manufacturing of pharmaceuticals in 2018, and the Guidelines for Continuous Manufacturing of Drug Substances and Drug Products (Q13) came into effect in Japan in May 2023. The ICH Q13 guideline applies to both drug substances and drug products for synthetic drugs and therapeutic proteins, and it consists of the main text and annexes. The main text describes the basic concept and points to be noted in the implementation of continuous manufacturing. The annexes contain illustrative examples and considerations specific to certain modalities. This article provides an overview of the ICH Q13 guideline, referring to the background and basic concepts (eg. scientific approach and regulatory considerations) described in the ICH Q13 guideline.