Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs

Managing IMP supply

The use of a Sponsor Pharmacy manual/Sponsor IMP management document may be of use to ensure clarity of all operations being undertaken for the specified trial. This document will be updated throughout the lifespan of the trial depending on the changing landscape of the trial and alterations to the IMP supply chain or manufacturing.

The Sponsor Lead Pharmacist should agree specification for the IMP and any appropriate analytical testing required. This information would be contained in the IMPD/sIMPD.

Vendor Assessment

A vendor assessment is required where IMP manufacturing, labelling and distribution are delegated to a third party.

Where the vendor assessment deems that an audit is necessary to assess the manufacturer and laboratory, this is a specialist requirement. The auditor should be competent in manufacture and quality control of product type. Depending on the level of experience/complexity of the IMP, the expertise of a QP auditor should be engaged.

Technical Agreement/Quality Agreements (QTAs)

QTAs must be put in place between the sponsor and the vendor to document respective responsibilities, and must include the quality standards that will be adhered to (e.g. GCP, GMP, GDP). In some cases, this may be also present as a separate section in the general contract agreement with the Sponsor.

The Sponsor Lead Pharmacist must check the technical agreement(s) in place for the IMP supplies; this includes manufacturing and distribution of IMP. This must be done in accordance to Good Manufacturing Practice. The following checklist provides a guideline of activities that should be considered. Note these may vary depending on the nature of the product and specific arrangements of the trial.

UK use of IMP certified in an European Economic Area (EEA) listed country

As of 1 January 2022, there is a regulatory requirement for IMP that will be delivered to UK sites to undergo QP assurance. This is to be provided for IMP which has been QP certified in an EEA listed country.

The Sponsor Lead Pharmacist must ensure that where this is relevant to the trial, there is an appropriate MIA(IMP) holder in the UK undertaking the relevant responsibilities to ensure that the IMP is compliant with UK regulatory requirements.