Continuous Manufacturing of Drug Substances and Drug Products – FDA announces guidance for Industry

FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products in March 2023. The document represents, according to FDA, a proactive step the FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls. FDA is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper by May 1, 2023.

The 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, according to FDA, clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.

The FDA emphasizes that it will continue taking necessary steps to facilitate the pharmaceutical industry’s implementation of CM and other emerging technologies that can improve product quality and help address many of the underlying causes of drug shortages and recalls.

Download the guidance paper here: Continuous Manufacturing of Drug Substances and Drug Products – Guidance for Industry

You want to provide input or see the original FDA page?

Source: FDA