Issue Date: March 1, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q13 Continuous Manufacturing of Drug Substances and Drug Products: Guidance for Industry
This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.
Download the Guidance Document
