Regulatory Inspection

Less than 1 min 16/11/21
Author name: met_ra_ric

Metrics Contract Services Completes Anvisa Regulatory Inspection

Metrics Contract Services, a division of Mayne Pharma, is pleased to announce that its Greenville, North Carolina facility has successfully completed an inspection 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 United States FDA, the Japanese PMDA, the Turkish Ministry of Health, the Russian Federation, and the Brazilian National Health Surveillance Agency.

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.”

The recent five-day audit examined numerous areas, including Utilities, Validation, Quality Control, Operations, Quality Assurance and Supply Chain. According to Ross, the favorable outcome from this inspection “reflects our commitment to always improving our quality systems and processes to satisfy a global regulatory standard.”