Q13 Continuous Manufacturing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Q13 Continuous Manufacturing of Drug Substances and Drug Products." The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug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 The draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM.