What is the UK QP oversight process for Investigational Medicinal Products?
Sponsors of a UK clinical trial using IMPs imported into Great Britain from countries on an ‘approved country for import’ list (initially, all EU and EEA countries) require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to check the IMPs have been certified by a Qualified Person (QP) in a listed country, before release to the trial. The MIA (IMP) holder needs an appropriate quality assurance system.
This assurance system must be overseen by a QP; however, the IMP does not require recertification.
There are two routes for IMPs to be received into Great Britain from a listed country for use in UK clinical trials following QP certification by the listed country MIA(IMP) holder:
• direct to the Great Britain clinical trial site
• via a Great Britain storage and distribution ‘hub’.
Note: If the oversight process is used then this does not require a UK QP Declaration.
Quality Agreements which describe the assigned responsibilities and provision of relevant information between the organisations must be in place. These include agreements between:
• Sponsor and the UK MIA(IMP) holder responsible for the oversight of import from the listed country
• Sponsor and the listed country MIA(IMP) holder
• UK MIA(IMP) holder and Great Britain storage and distribution hub (if applicable)
• Sponsor and Great Britain storage and distribution hub (if applicable)
The QP named on the UK MIA(IMP) should have the following documentation available as part of the oversight process for import of IMP to Great Britain from listed countries:
• details of the manufacturing and distribution supply chain.
• the UK Clinical Trial Application form, plus amendments. This should be used to confirm the site responsible for final certification of the finished IMP.
• the UK Clinical Trial Application and any amendment approval records (including any post approval commitment requirements).
• evidence that the certifying site in the listed country is appropriately licensed and holds a current GMP certificate for the IMP dosage form(s) and associated activities (e.g. manufacture, packaging, testing and / or import from a third country).
• details of the approved Great Britain trial sites from the ethics application, plus any updates or amendments.
• details of each shipment of IMP to Great Britain including the addressees’ information. This should be verified against the ethics approvals.
• details of any excursions from the stated storage conditions during shipment, along with any decisions taken by the Sponsor and certifying QP, and the rationale for those decisions.
• details of the responsibilities described in the written agreement between the Sponsor and the listed country MIA(IMP) holder.
Further documentation may be required depending on the responsibilities of each organisation in the supply chain.