Laboratory

Prior to January 1 2002, the MHRA had used private contract laboratories for the testing of samples within the Medicines Testing programme.  A long standing arrangement with the Royal Pharmaceutical Society had existed for the testing of samples at the Medicines Testing Laboratory (MTL) in Edinburgh and the critical 'on-demand' samples, such as enforcement samples, inspection samples and defective products were analysed there. For surveillance projects, approved laboratories were awarded the contract for the work following a tendering exercise.  Whilst these arrangements provided good value for money and efficient use of resources they were not ideal.

In order to address the limitations of the contract testing arrangements, the Agency Board agreed, in 2000, to proposals for a MHRA laboratory.  The laboratory was to be a joint collaboration with an established centre of excellence in the physico-chemical analysis of medicinal products.  The laboratory would be a clearly identified separate facility that would undertake work solely for the MHRA and within which MHRA would be able to control prioritisation of work.

Following a formal tendering process the contract was awarded to the Laboratory of the Government Chemist (LGC).  A laboratory area on the LGC site was refurbished and equipped for physico-chemical analysis of medicinal products. Capital costs were met by the MHRA and revenue costs were covered by the existing revenue budget for medicine testing.  It is a self-contained laboratory unit managed and run by LGC with the work load and prioritisation decided by MHRA.  Since staff in the laboratory work solely on MHRA projects there are no conflicts of interest.

The contract for the new laboratory was agreed and signed in September 2001 and the laboratory became operational in January 2002. It took the laboratory some time to become established but by 2003-4 laboratory outputs and outcomes were exceeding those achieved prior to the change. The laboratory now performs the majority of the MHRA physico-chemical analysis of medicinal products. It provides expert reports in support of MHRA prosecutors and is accredited under Scottish Law for this activity.