Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP)

AI Summary

This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for incorporating Decentralised Manufacturing (DM) within a Clinical Trial Application (CTA). Under the UK regulatory framework for Investigational Medicinal Products (IMPs), companies must first obtain a specific DM designation to justify this manufacturing approach. A primary requirement is the appointment of a 'Control Site' that holds a valid Manufacturing and Import Authorisation (MIA) and is certified to oversee the decentralized process before the CTA is submitted. Organizations must provide comprehensive documentation, including a DM master file, batch analysis data from representative manufacturing locations, and detailed quality dossiers. For complex products, the MHRA requires evidence of process validation and comparability between different manufacturing sites. Additionally, if Real Time Release Testing (RTRT) is used, the application must reflect advanced process knowledge as per Eudralex Volume 4, Annex 17. A critical focus is placed on maintaining the integrity of blinded trials; sponsors are required to implement strict controls to ensure that point-of-care manufacturing—such as the time taken to prepare a dose or the equipment used—does not inadvertently reveal treatment assignments to participants or investigators. Actions for compliance include keeping DM designations current and performing periodic reviews of blinding controls.