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Covance Adds cGMP Melamine Testing Service

Covance, Inc. has added cGMP melamine testing services in North America to meet recent FDA guidance on melamine testing for pharmaceutical and animal health manufacturers.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Covance, Inc. has added cGMP melamine testing services in North America to meet recent FDA guidance on melamine testing for pharmaceutical and animal health manufacturers.

The company developed the new melamine testing method in food and nutritional chemistry products using LC-MS technology to significantly reduce the risk of melamine contamination in pharmaceutical excipients and products.

The FDA issued Pharmaceutical Industry Guidance on Preventing Melamine Contamination in August 2009, prompted by recent incidents involving food products in China and the U.S. 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, Ph.D., president, analytical services, Covance. “Our method has demonstrated a significantly better sensitivity than recommended by the guidance, which provides our global clients greater assurance of product safety and an earlier opportunity for process optimization.”

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