The laboratory holds a GMP Test Site (Biologicals) certificate from the MHRA. This means it is authorised to perform biological QC testing in accordance with Art. 111(1) of directive 2001/83/EC (or Article 80(1) of Directive 2001/82/EC) transposed in the following national legislation: For human medicines ‘The Medicines Act 1968 as amended’; for veterinary medicines ‘The current Veterinary Medicines Regulations’; for investigational medicinal products ‘The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)’.
It also operates to the international standard of Good Laboratory Practice (Good Laboratory Practice Regulations SI 1999:3106 as amended by SI 2004:994) as inspected by the UK Department of Health. All results are internally quality controlled before reporting.
It is accredited by UKAS to ISO/IEC 17025:2005 for diagnostic tests where relevant. Accreditation not only assures the quality of the tests performed, it also covers customer service, procedure validation, supplier performance, and organisation management.
The lab is a VMD authorised Equine Stem Cell Centre. This authorisation allows preparation autologous mesenchymal stem cells for use in the treatment of tendon and ligament injuries in horses.