USFDA sends warning to Glenmark Pharmaceuticals over lapses in Goa plant

12 Dec 2022 , 08:45 AM

The US health authorities have reprimanded Glenmark Pharmaceuticals for manufacturing errors at its Goa-based manufacturing facility, including failure to set up necessary laboratory control systems.

In a letter of warning to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the USFDA identified a number of violations at the company’s Bardez-based facility in Goa, where medicinal formulations are made.

The warning letter “summarises numerous infractions of Current Good Manufacturing Practice (CGMP) rules for finished pharmaceuticals,” according to the US Health regulator, according to PTI.

The manufacturing plant was inspected by the USFDA from May 12, 2022, to May 20, 2022.

The company was warned for failing “to adequately analyse any inexplicable disparity or failure of a batch or any of its components to fulfil any of its criteria,” according to the US health authorities.

Additionally, it drew attention to the management of the plant’s failure to set up sufficient written processes for production and process control intended to ensure that the manufactured drug products have the identity, strength, quality, and purity they claim or are represented to have.

Additionally, the USFDA claimed that the plant administration did not set up and adhere to essential laboratory control methods.

Additionally, the USFDA claimed that the chromatographic data integration technique is insufficient since it does not specify when the analyst can manually input timed integration events, how to use these events, or how to review them.

The corporation was also cited by the US health agency for failing to compile batch production and control records that contained comprehensive data on the manufacturing and control of each batch of drug product manufactured.

The infringement is typically specified in the warning letter sent by the USFDA, such as faulty manufacturing procedures, issues with product claims, or inappropriate usage instructions.

The letter also specifies that the business must fix the issue and offers guidelines and a timetable for how it intends to do so.

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