Investigational Medicinal Products (IMPs) to be used in an EU clinical trial must be certified by a Qualified Person (QP) named on a Manufacturing and Import Authorisation (MIA(IMP)) to ensure the products have been manufactured, tested, stored, and supplied in compliance with Good Manufacturing Practice (GMP) – Eudralex Vol. 4, Annex 13.
For IMPs imported from third countries, a QP declaration of GMP is required to be submitted with the Clinical Trial Application (CTA) in accordance with EU clinical trials regulation 536/2014. The QP would typically perform a GMP audit of the product manufacturing and testing sites in order to provide this declaration; however, if suitable third-party audit reports are available these may be accepted upon review.
The EU depot (site of physical importation) holding the appropriate MIA(IMP) will either receive bulk IMPs for packaging & labelling or finished product requiring no further processing.
A Product Specification File will be set up by the EU depot, which will be reviewed and approved by the QP. Review of the manufacturing and packaging batch records will be performed by the QP against the PSF and the finished product will then be QP certified.
In addition to QP certification there is also a requirement for the “Regulatory Green Light” where the study sponsor is responsible for ensuring the required QP certification, regulatory authority and ethics committee approvals have been obtained prior to releasing the clinical trial material to the clinical trial sites.
Following distribution to the clinical sites on receipt of an approved shipping order from the sponsor or their authorised representative, it is good practice to obtain confirmation of receipt and temperature data for the shipment to verify that the supplies were delivered correctly under the appropriate conditions.