Merck Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre
Merck Millipore, the Life Science division of Merck, has announced that its Biodevelopment Centre in Martillac, France, has been recertified by the French National Agency for Medicines and Health Products Safety (ANSM), the competent authority of France. The certification confirms the 3,440 m2 facility complies with the principles of GMP for active substances.
The audit included a thorough review of quality systems, supplier management, control of raw materials, documentation, calibration and validation. Prior certification consisted only of stainless steel equipment, while this recertification included complete single-use upstream and downstream suites, as well as a 2 x 1,250 l stainless steel suite.
Merck Millipore’s Provantage biodevelopment and clinical supply services are delivered at the facility. This approach for biologics manufacturing incorporates the latest technologies in upstream, downstream and single-use systems. This Provantage offering includes process development and GMP drug substance for pre-clinical to phase II and is available to a global customer base.
“We are proud to be one of the first facilities to attain GMP compliance utilising single-use equipment for each unit operation from upstream through downstream. This recertification reflects the teamwork and dedication of our entire staff and provides our customers with complete confidence in our technical expertise and quality,” noted Richard Pearce, Business and Operations Director of the Biodevelopment Centre.
Merck Millipore, +1 781 533 5336, pegeen.dossantos@emdmillipore.com, www.merckmillipore.com.