At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues its legacy of innovation by rapidly developing new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.
The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products (21 CFR 211.84). It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product.
In response to the FDA’s new guidance titled “Pharmaceutical Components at Risk for Melamine Contamination,” Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid”).
Catalent is now able to provide its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.
Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and moldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.
“Catalent is proud to have satisfied the demanding regulatory standards the US FDA has provided for detecting melamine,” said Kent Payne, Vice President and General Manager of Catalent’s Respiratory, Analytical and Biotechnology Services business. “Detecting trace levels of melamine in food and medicinal products at these levels is a challenging process, but is key to help avoid future public health crises. In order to support this critical public health need, Catalent can expedite this testing and provide results within 48 hours from receipt of samples
Fore more information on the US FDA guidelines, please visit:
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.