U.S. Drug Regulator Flags Seven Concerns About Glenmark’s Baddi Unit
The U.S. drug regulator made seven observations for Glenmark Pharamceuticals’ Baddi unit.
The U.S. drug regulator flagged concerns about procedures followed at Glenmark Pharmaceuticals Ltd.’s Baddi facility in Himachal Pradesh.
The Food and Drug Administration issued seven observations, which include Glenmark’s failure to thoroughly review unexplained discrepancies, lack of written procedures for production and process control, and deficient complaint records, according to documents reviewed by BloombergQuint. The Baddi facility, a finished dosage unit, was inspected between Nov. 6 and Nov. 11.
"We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations,” the Mumbai-based drugmaker said in an exchange filing.
Shares of the drugmaker fell as much as 3.1 percent to Rs 572.3 apiece on the BSE after the filing. The Baddi unit contributes approximately 10 percent to Glenmark’s U.S. sales, or around $60 million, Deepak Malik, a pharmaceutical analyst at Edelweiss Securities Ltd. wrote in a report. The chances of escalation are low as there are no data integrity or repeat observations, Malik said.
This was a Good Manufacturing Practices inspection and the last inspection that happened was in March 2017 when it got no observation. We believe chances of escalation are low here even though first observation is very similar to Lupin Ltd.’s Goa and Indore plant observations. In Lupin’s case it was a repeat observation at multiple locations.Deepak Malik, Analyst, Edelweiss Securities
The FDA’s Seven Observations
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed.Observation 1
During interviews conducted, the questions and answers were not contemporaneously recorded, according to the regulator.
There are no written procedures for production and process control designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possessObservation 2
Complaint records are deficient in that they do not include the findings of the investigation and follow upObservation 3
This observation refers to consumer complaints on products sold in the U.S. markets. The FDA notes that Glenmark failed to conduct a comprehensive investigation to determine whether the hold time had any impact on the quality of the product. The FDA also noted that Glenmark did not include review of all the retain samples that were part of the complaint lot.
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.Observation 4
The U.S. drug regulator notes that data compiled for filing Annual Product Quality Review (APQR) was not reviewed for accuracy. The FDA notes that the files were deleted after statistical evaluation was printed. These electronic files were not available for evaluation.
The responsibilities and procedures applicable to the quality control unit are not fully followed.Observation 5
This observation refers to change control notifications. The FDA also noted of instances of document shredding.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel.Observation 6
The regulator noted that a warehouse employee was able to access quality folder as well as create or delete documents.
Employees are not given training in particular operations they perform as part of their function.Observation 7