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The QMN Weekly Bulletin

German Regulators Cite Documentation, Data Integrity at India Simvastatin Lab

Sept. 16, 2016

Regulators in Germany have cited a lab in India with litany of GMP violations and have recommended a prohibition of supply.

The German regulator Landesportal Schleswig Holstein-Landesamt Für Soziale Dienste found 35 GMP violations at Artemis Biotech in India. The company, a division of Themis Medicare, manufactures the cholesterol drug Simvastatin.

Five of the violations are listed as major deficiencies, including repackaging operations being conducted without documentation or oversight, as well as data integrity issues.

Despite finding the violations, regulators said that no recall was needed, although they did recommend that Artemis be prohibited from continuing to supply Simvastatin and should not be approved in any new or ongoing applications.

FDA warning letters are increasing for GMP facilities due to cite violations in raw materials management. The FDA’s investigators give special scrutiny to sourcing, handling, control, use and tracking of raw materials. Be prepared and informed with GMP Risk Management training.

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