The European Medicines Agency (EMA) has adopted the ICH guidance on the continuous manufacturing of drug substances and drug products which marks the Step 5 process of document adoption by the Regulatory Members of the ICH Assembly. The document was released on 6 January 2023 and will come into effect on 10 July 2023.
The guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, it provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products for chemical entities and therapeutic proteins. It applies to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products. The principles described in the guideline may also apply to other biological/biotechnological entities.