CTS Durham Undergoes EU-GMP Inspection From MHRA
May 4, 2006
Clinical Trial Services (CTS) announces that following a recent inspection of the CTS Durham (NC) facility by the Medicines and Healthcare products Regulatory Agency (MHRA-UK), a letter of general compliance has been issued by the UK regulatory body.
The issue of a letter of compliance followed a recent voluntary inspection of the CTS Durham site and quality systems by two representatives of the MHRA on January 26th and 27th. The inspection examined the US site in terms of reference against the published EU guidelines on Good Manufacturing Practice (GMP) and found that CTS Durham were compliant with these guidelines.
Reflecting the global nature of clinical trials, the letter of general compliance demonstrates the need to adhere to the principles of GMP and the importance of consistent quality procedures across all sites involved in packaging and distribution of clinical trial supplies. CTS Durham now joins CTS Audubon (PA) in formally demonstrating EU GMP compliance.
Commenting on the inspection, Dr Robert Dunlop (Senior VP, CTS) said: “This is a tremendous achievement for CTS Durham and I would like to congratulate all the CTS staff involved in achieving this recognition. For our clients, this is a further demonstration by CTS of its commitment to providing leading quality practices in support of their global clinical trial requirements.”
Mr Paul O’Connor (Global VP Quality, CTS) added “This is excellent news for CTS Durham and testament to the quality and skill of our staff. At CTS we recognize the global scope, relevance and impact of our sphere of work. This ‘extra mile’ of cross market compliance echoes our commitment to be a world leader on quality and on service – wherever we do business.”
CTS is a globally positioned company focused on provision of solutions for clinical trial supplies. CTS enables client companies to meet their trial start dates by leveraging of experienced staff and flexibility with robust quality systems. Services provided by CTS include blinding, packaging, labeling, global distribution, QP release, analytical testing, drug supply management and online randomisation via the WEBEZTM system.
Almac Sciences and its affiliated companies (CSS (Chemical Synthesis Services), CTS (Clinical Trial Services), ICTI (Interactive Clinical Technologies Incorporated), PDMS (Pharmaceutical Development and Manufacturing Services) and Almac Diagnostic Services) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.
CTS Global Marketing Manager
+44 28 38 363857