Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

A new industry guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, issued in March 2023 by FDA, explains the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance and to provide clarification on CM concepts while further describing scientific approaches and regulatory considerations specific to CM of drug substances and drug products.

Further, the guidance applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It can be applicable to CM for new products, such as new drugs, generic drugs, and biosimilars, and for the conversion of batch manufacturing to CM for existing products.

Source: FDA