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Metrics Completes Japanese Regulatory Inspection

Marks the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Metrics Contract Services, a division of Mayne Pharma, said that its facility in Greenville, NC, 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 (FDA) and the PMDA. A site inspection by the European Medicines Agency is anticipated in early 2020.
 
“Successfully completing an audit to Japanese GMP standards confirms, once again, Metrics Contract Services’ consistent commitment to quality in its  manufacturing and testing operations,” said John Ross, president, Mayne Pharma USA.
 
The recent four-day audit examined numerous areas, including quality control, operations, quality assurance and supply chain.
 

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