New Delhi: The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant. In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company’s Bardez-based facility in Goa, which produces drug formulations.
The US Health regulator noted that the “warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.”
It further said: “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated…”
The USFDA inspected the manufacturing facility from May 12, 2022, to May 20, 2022.
In the warning letter, the US health regulator pointed out the company’s failure “to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications”.
“Your investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings,” it noted.
It also pointed out failure on the part of the plant management to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality and purity they purport or are represented to possess.
USFDA also said the plant administration failed to establish and follow required laboratory control mechanisms.
“Your firm failed to have appropriate procedures for the integration of chromatographic peaks and for the review of chromatographic data processing. Our investigators identified an example of your firm manually entering timed integration events into the processing methods and reporting passing results without adequate procedural controls or justification,” it said.
In addition, the chromatographic data integration procedure is inadequate because it does not indicate when the analyst can manually input timed integration events, how these events should be used, or how they should be reviewed, USFDA said.
The US health regulator also pointed out that the company failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.
It asked the Mumbai-based drug maker to come up with a remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products.
“Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing including both production and packaging operations meet appropriate parameters and quality standards.
“The warning letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence,” it said.
The warning letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.
USFDA then checks to ensure that the company’s corrections are adequate.