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ICH Q13 Draft Guideline reaches Step 2 of the ICH process

ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2 of the ICH process and now enters the public consultation period.

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).

Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable 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 this guideline may also apply to other biological/biotechnological entities.

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