Exclusive: U.S. FDA Flags Quality Lapses At Glenmark Pharma’s Baddi Facility
Three of the six observations were a repeat.
The U.S. drug regulator has flagged quality control and procedural lapses at Glenmark Pharmaceuticals Ltd.’s Baddi facility that caters to the American market.
The U.S. Food and Drug Administration, after completion of its inspection at the non-sterile finished drugmaking unit located in Solan, Himachal Pradesh, on June 22, had issued a Form 483 with six observations, the Mumbai-based company’s exchange filing had said then, without disclosing any details.
BQ Prime has obtained a copy of the observations from the FDA. Three of the six observations were a repeat.
These are:
The FDA found that broken or cracked caps was an issue for one of the company’s products which eventually led to recalling of product batches, as the company had failed to assess the impact before distribution. Failure to review a batch or its components for any unexplained discrepancy or to meet specifications whether the batch was distributed or not is a repeat observation from the 2017 and 2019 FDA inspections.
Vessels used in manufacturing and transfer of finished drugs which required their interior surface to be smooth, had imperfections and scratches that could impede cleaning capability and provide cavities for contaminants. Also, written procedures for drying of the tubing process do not provide clear details on visual inspection by personnel. This could impact the quality, safety, purity of the drug product. This is a repeat observation from 2019 inspection.
The company had failed to submit field alert report within three working days of receipt of complaints regarding container leakages of packaged drugs and observation of metallic particulates in a drug batch impacting homogeneity of the product, which is otherwise required to be submitted on receipt of information. This was also a repeat observation from 2019 inspection.
The company did not evaluate the operating ranges for critical process parameters such as temperature and packaging process / filling configuration. Non-assessment during process validation led to distribution of products manufactured using non-validated equipment configuration and operational parameters.
Procedures applicable to quality control unit are not in writing and fully followed. Some standard operating procedures relating to use and cleaning of storage vessels and sampling and testing were not followed and/ or no documentary evidence was kept.
The company failed to demonstrate that the electronic data stored by standalone biometric fingerprint access, matched the written records identifying personnel authorised to access these areas.
Glenmark, in its June filing, had said it was committed to undertake all necessary steps required to address the U.S. FDA observations at the earliest and to maintain the highest quality manufacturing standards at all of its facilities across the globe.
The company, however, has yet to respond to BQ Prime’s emailed queries on the implications of the observations and the revenue contribution of the facility to its overall top line.
The U.S. contributed 24% to Glenmark Pharma’s total sales in the quarter ended March 2022. The first-quarter FY23 results are yet to be announced.
Since the closing of June 22, shares of Glenmark have fallen 1.1%. The stock was trading 1.04% lower compared with a 0.68% fall in the benchmark Sensex as of 11:03 a.m. on Tuesday.