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Metrics Contract Services Successfully Completes ANVISA Inspection

For commercial manufacture of a branded oncology drug to be marketed in Brazil.

By: Kristin Brooks

Managing Editor, Contract Pharma

Metrics Contract Services, a division of Mayne Pharma, has successfully completed an inspection at its Greenville, NC facility by the Agência Nacional de Vigilância Sanitária, or the Brazilian National Health Surveillance Agency (ANVISA), for commercial manufacture of a branded oncology drug to be marketed in Brazil. This is the fourth international inspection to evaluate the 126,000-sq-ft commercial manufacturing facility completed in 2018.
 
With this satisfactory inspection, Metrics Contract Services now has GMP approvable inspections by the U.S. FDA, the Japanese PMDA, the Turkish Ministry of Health, the Russian Federation, and the Brazilian National Health Surveillance Agency.
 
The recent five-day audit examined Utilities, Validation, Quality Control, Operations, Quality Assurance and Supply Chain.
 
Mayne Pharma President John Ross said, “Successfully completing an audit to Brazilian GMP standards is an important milestone on our journey to provide a comprehensive offering to clients from initial concept to global commercial supply in oral solid dose.”
 

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