Drugs

CGMP Violations at Glenmark Unit

A 2/3-2/14 FDA inspection at the Glenmark Pharmaceuticals Limited drug manufacturing facility in Pithampur, Madhya Pradesh, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says the specific violations were:

failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure to follow an adequate written testing program designed to assess the stability characteristics of drug products; and
failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter notes that Warning Letters have been issued to other Glenmark units for similar violations. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” FDA says. The agency acknowledges the company’s commitment to cease production of two products for the U.S. market and asks whether Glenmark intends to resume manufacturing operations.

FDA recommends that Glenmark retain a qualified consultant to assist it in meeting CGMP requirements.

The company was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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