Provision of Radiopharmacy Validation Services

Descriptions

The Royal Marsden NHS Foundation Trust (RMT) is currently planning the build of a new Radiopharmacy facility. The existing facility holds manufacturing authorisations, issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), for both unlicensed “specials” and investigational medicinal products. It is intended that the new facility will meet the required standards to be licensed by the MHRA. RMT requires an experienced contractor to assist with validation of the new Radiopharmacy to EU Good Manufacturing Practice (GMP) standards. This will involve aspects of Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) of the new Radiopharmacy facility. The appointed validation contractor will be responsible for directly validating the cleanroom facilities and associated environment and HVAC, and for overseeing the IQ / OQ activity undertaken by the specialist equipment manufacturers.