Q13 Continuous Manufacturing (CM) of Drug Substances and Drug Products

1 March 2023 – the FDA published the final ICH Q13 guidance on the CM of drug substances and drug products.

This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidance, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.