Covance Announces New cGMP Melamine Testing Service
PRINCETON, NJ
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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
