Metrics Contract Services and Mayne Pharma Complete Japanese Regulatory Inspection
Nov. 15, 2019, Greenville, N.C. – Metrics Contract Services, a division of Mayne Pharma, is pleased to announce that its facility in Greenville, N.C., has successfully completed a Pharmaceuticals and Medical Devices Agency (PMDA) inspection for commercial manufacture of a branded oncology drug to be marketed in Japan.
This was the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.
With this satisfactory inspection, Metrics Contract Services now has Good Manufacturing Practices (GMP) approvals from both the U.S. Food and Drug Administration and the PMDA. A site inspection by the European Medicines Agency is anticipated in early 2020.
Mayne Pharma USA President John Ross said, “Successfully completing an audit to Japanese GMP standards confirms, once again, Metrics Contract Services’ consistent commitment to quality in its manufacturing and testing operations.”
The recent four-day audit examined numerous areas, including quality control, operations, quality assurance and supply chain. According to Ross, the favorable outcome from this inspection “reflects our dedication to improving and maintaining the highest quality standards.”