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EMA – Publication of the ICH guideline Q13 on continuous manufacturing of drug substances and drug products

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.

The ICH Q13 Guideline will come into effect on 10 July 2023.

More information on the EMA website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (19 avril 2023). EMA – Publication of the ICH guideline Q13 on continuous manufacturing of drug substances and drug products. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o68u


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