Drugs

CGMP Deviations at Vega Life Sciences

An 11/25-11/28/19 FDA inspection at Vega Life Sciences, Sangreddy District, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 6/17 Warning Letter says the specific deviations were:

failing to control and monitor solvent recovery procedures to ensure that solvents meet appropriate standards before reuse in API manufacturing;
failing to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API; and
failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failing to have adequate controls to prevent omission of data.

The letter says Vega’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA recommends that the firm retain a qualified consultant to assist it in data integrity remediation. Vega was told to provide (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed in the U.S.; (2) a current risk assessment of the potential effects of the observed failures on the quality of Vega’s drugs; and (3) a management strategy for the firm including details of a global corrective and preventive action plan.

FDA also recommends that Vega engage a consultant qualified to evaluate its operations and assist it in meeting CGMP requirements. It recommends that the consultant perform a comprehensive audit of the company’s entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before Vega pursues resolution of its compliance status with FDA.

FDA acknowledges the firm’s commitment to terminate processing recovered solvents for customers at this facility for the U.S. market. It placed Vega on an import alert on 4/14. The company was told to respond with a list of steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completing the steps.

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