In a warning letter addressed to Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals, the US Food and Medicinal Administration (USFDA) discovered a number of failures at the Bardez, Goa-based plant of Glenmark Pharmaceuticals that produces drug formulations.
According to the US Health Authority, the warning notice details major violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
As per the Mint, the USFDA inspected the manufacturing facility from May 12 to May 20. According to the government, the company’s drug goods are contaminated because its manufacturing, processing, packaging, or holding techniques, facilities, or controls do not adhere to CGMP standards.
In the warning letter sent to the corporation, U.S. health regulators emphasized the company’s inability to analyze thoroughly any unexplained variation or failure of a batch or any of its components to meet any of its requirements. It was stated that Glenmark’s investigations of rejected batches did not include other batches, dosage levels, or medications for tablet compression machine settings.
In addition, it drew attention to the management of the plant’s failure to establish adequate written processes for production and process control to verify that the manufactured drug items possess the claimed or represented identity, potency, quality, and purity. The USFDA additionally charged the plant administration with failing to implement and adhere to the required laboratory control measures.
According to the report, Glenmark did not follow the correct procedures for reviewing the processing of chromatographic data and integrating chromatographic peaks.
USFDA investigators discovered a situation in which a business manually incorporated timed integration events into processing processes and claimed successful findings without the required procedural safeguards or justification.
USFDA stated that the chromatographic data integration method is inadequate since it does not specify when the analyst can manually input timed integration events, how to use them, or how to review them.
The US health authorities also cited the company’s inability to compile batch production and control records that included complete data on the manufacture and control of each batch of drug product manufactured.