Rosalind Franklin Laboratory

Brief:

The GMP Group were requested to assist the client UKHSA by Mace Projects. The brief entailed the qualification of all equipment in the new PCA testing facility known as the Rosalind Franklin Laboratory. The lab consisted of 12 process laboratory lines, each capable of 25,000 tests per 24 hours.

What we did:

GMPG responded immediately with a resource plan for the initial 4 laboratory lines. Working with the onsite QA team, GMPG developed the VMP and protocal templates for IQOQ (Installation Qualification / Operational Qualification) of the laboratory equipment. This included the determination of all critical quality attributes of IQ and OQ protocols. The GMPG site team eventually qualified over 400 items of equipment, plus the thermal mapping of warehouse coldrooms and bulk freezers. 

Results:

With an intense programe of works, GMPG were able to ensure that all qualifiation works were completed on time to meet the start up dates for each line joining the workstream.