CRED Getting the CMC Dossier Right 2024

05/09/2024

Production and Scale Up

• Is the development site going to be used for commercial production or is it going to be transferred to another site?

• ICH Q10 mentions Technology Transfers:

• The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing sites, or between manufacturing sites to achieve product realisation. • This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement

• SUPAC-IR guidance in US considers equivalence in equipment

• Regulatory, Development Site and Production Site need close communication to ensure correct information is in dossier

The Organisation for Professionals in Regulatory Affairs

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Guidance on Production Details in dossier

EMA/CHMP/QWP/245074/2015

• Different sites can use slightly different processes provided the operating principles are the same

• Include information on intermediate and bulk hold times

• Clearly define the critical process parameters and justification for control. Justify why process parameter has been designated non-critical. • Increasing emphasis on complicated supply chains and use of contract sites • Provide sufficient detail on process parameter settings, equipment etc., however, balance the potential for many post approval variations

The Organisation for Professionals in Regulatory Affairs

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