The US Food and Drug Administration (USFDA) identified a number of failures at the Glenmark Pharmaceuticals’ Bardez-based facility in Goa, creating drug formulations, in a warning letter sent to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha. The warning notice lists serious infractions of Current Good Manufacturing Practice (CGMP) rules for finished pharmaceuticals, according to the US Health Authority.
The USFDA conducted an inspection of the manufacturing plant from May 12 to 20. According to the agency, the company’s manufacturing, processing, packing or holding procedures, facilities or controls do not follow CGMP standards, and as a result, its drug products are adulterated.
In the warning letter that was delivered to the corporation, the US health authorities emphasised the company’s inability to thoroughly analyse any unexplained difference or failure of a batch or any of its components to meet any of its requirements. Investigations of rejected batches by Glenmark did not cover other batches, dosage levels, or pharmaceuticals for tablet compression machine settings, it said.
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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. The plant administration was also accused by the USFDA of failing to set up and adhere to the necessary laboratory control systems.
Glenmark did not follow the proper processes for reviewing the processing of chromatographic data and integrating chromatographic peaks, it said. Investigators for the USFDA found a case where the company manually entered timed integration events into the processing techniques and reported successful findings without the necessary procedural safeguards or rationale.
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The chromatographic data integration technique is also insufficient because it does not state when the analyst can manually input timed integration events, how to use these events, or how to review them, USFDA said.
The company’s failure to compile batch production and control records that included comprehensive data on the manufacture and control of each batch of drug product produced was also called out by the US health agency.
(With agency inputs)
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