Q13 Continuous Manufacturing of Drug Substances and Drug Products; International Council for Harmonisation; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Q13 Continuous Manufacturing of Drug Substances and Drug Products." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and life-cycle management of CM. The guidance replaces the draft guidance entitled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" issued on October 14, 2021. This guidance also replaces the draft guidance entitled "Quality Considerations for Continuous Manufacturing" issued on February 27, 2019.