Gen-Probe’s analytical service laboratories pass FDA inspection
Site already certified by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for GMP, GLP and GCP compliance
Gen-Probe’s Tepnel Pharma Services, a provider of outsourced services and solutions to the drug development and biotechnology sectors, is pleased to announce that its analytical laboratories in Livingston, Scotland, have successfully passed a GMP inspection by the US Food and Drug Administration (FDA) without any “Form 483” citations.
This is the second audit by the FDA since Tepnel relocated to its current facilities in 2008, and sits alongside the certification by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for GMP, GLP and GCP compliance at the site.
Carl Hull, CEO of Gen-Probe Incorporated, said, 'This accomplishment reflects our long-standing corporate commitment to quality and regulatory compliance.' David Scott, Senior Director, Commercial Services and Diaclone, added, 'The success of this inspection is testament to the hard work, understanding and commitment of Tepnel to provide regulatory compliant services to our customers. In conjunction with our MHRA accreditations, it confirms our quality system meets the highest standards expected of a modern global service provider.'
Gen-Probe’s Tepnel Pharma Services is a global provider of outsourced services to the drug development industry. With more than 20 years of experience in both large and small molecules, Tepnel specialises in providing pharmaceutical testing and research in the areas of batch release and stability testing, clinical trials support including bioanalysis and pharmacogenomics, and immunology.
Tepnel Pharma Services is an established brand of Gen-Probe Incorporated, a world leader in molecular diagnostics.