contractpharmaMarch 10, 2021
Tag: Metrics , FDA , PMDA , GMP
Metrics Contract Services, a division of Mayne Pharma, said that its Greenville, NC facility has successfully completed an inspection by the Ministry of Industry and Trade of the Russian Federation for commercial manufacture of a branded oncology drug to be marketed in Russia. It is the third international inspection to evaluate the 126,000 square foot 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 and the Russian Federation.
“Successfully completing an audit to Russian GMP standards confirms, once again, Metrics Contract Services’ consistent commitment to quality in its manufacturing and testing operations,” said John Ross, president, Mayne Pharma.
The recent two-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 commitment to always improving our quality systems and processes to satisfy a global regulatory standard.”
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