Qualified Person Certification of Advanced Therapy Medicinal Products

The following rationale supports the proposed direct award under Schedule 5 of the Procurement Act 2023 on the grounds of technical reasons.

Exmoor Pharma QP brings specialist expertise in advanced therapies medicinal products, together with direct and extensive familiarity with T-reg and CAR-T reg manufacturing. This combination of advanced therapy experience and product-specific knowledge is highly specialised and is unlikely to be readily available from another QP. Such familiarity provides significant value in the assessment and oversight of manufacturing activities, deviations, investigations, quality decisions, and batch certification, where an understanding of the specific product, process and associated risks is essential.

Retaining this expertise therefore provides both a regulatory and operational benefit. It supports continued GMP compliance while avoiding the potentially lengthy learning period associated with transferring responsibility to a new QP who has no prior experience of the organisation or T-reg manufacturing process. It also reduces the risk of disruption to manufacturing activities and the consequential impact on production capacity and patient supply.

Guy’s and St Thomas’ NHS Foundation Trust is relying on Section 41 and Paragraph 6(a) and 7(b) of Schedule 5 of the Procurement Act 2023 to justify the use of direct award in special cases.