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Covance Inc. announced that it has added cGMP (current Good Manufacturing Process) melamine testing services in North America to meet recent U.S. Food and Drug Administration (FDA) guidance on melamine testing for pharmaceutical and animal health manufacturers.
Covance developed the new cGMP-compliant method for melamine testing in food and nutritional chemistry products using advanced LC-MS technology to significantly reduce the risk of contamination by melamine and its related analogs in pharmaceutical excipients and products.
Prompted by recent incidents involving food products in China and the United States, the FDA issued Pharmaceutical Industry Guidance on Preventing Melamine Contamination in August 2009 to avoid potential melamine contamination of pharmaceutical products. The guidance recommends melamine testing for certain pharmaceutical ingredients used in the manufacture or preparation of drug products.
“Covance is committed to ensuring the quality of every client product in compliance with the latest regulatory requirements,” said John Robson, PhD, president, analytical services, Covance.