Qualified Person Service for Investigational Medicinal Products (IMP)

NHS Blood and Transplant, NHSBT, is undertaking preliminary market engagement in connection with a proposed procurement for the provision of Qualified Person, QP, services for Investigational Medicinal Products, IMPs.

NHSBT is seeking to understand the capability, capacity and interest available within the market to provide suitably qualified and experienced QP support for its active portfolio of IMP manufacturing projects.

The proposed service may include:

Reviewing and providing regulatory and quality input into selected regulatory submissions, as requested by NHSBT.

Advising on applicable regulatory, Good Manufacturing Practice, GMP, and quality-compliance requirements for biological and Advanced Therapy Medicinal Product, ATMP, manufacturing projects.

Providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities.

Reviewing assigned batches and, where satisfied that all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying the batches for use in approved clinical trials.

Providing advice and guidance relating to the manufacture, certification and release of IMP batches.

Supporting NHSBT with the interpretation and application of relevant regulatory and quality requirements.

Mentoring selected NHSBT staff through the process of obtaining Qualified Person registration.

Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the United Kingdom.

The supplier may be required to provide supporting evidence of the proposed Qualified Person’s qualifications, professional eligibility, regulatory status and relevant experience.

Proposed personnel should have recent and demonstrable experience of:

acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products, MIA(IMP);

reviewing and certifying IMP batches;

applying UK regulatory, GMP and quality requirements;

supporting biological and biotechnology medicinal-product manufacturing;

supporting cell therapy and gene therapy medicinal products; and

working with complex IMP manufacturing projects and associated quality systems.

The current anticipated level of support is approximately 24 to 48 days per year. NHSBT currently anticipates that at least 50% of the required support will be delivered on NHSBT premises, with the remaining support delivered remotely by agreement.

The final scope, service-delivery arrangements, volume of activity and contract requirements may be refined following the preliminary market engagement exercise.

The current contract ends on 30 June 2027. NHSBT intends to have the replacement contractual arrangement in place by 31 March 2027 to support an appropriate transition period.