Factory ceilings which leaked and failure to follow written procedures designed to prevent microbiological contamination of drugs are some of the major norm violations found by the USFDA at Sun Pharma’s Halol plant.
According to the warning letter sent by the USFDA over the plant, the inspectors “identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
Besides, the US health regulator found that Sun Pharma “failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel”.
The significant violations included the company’s failure “to maintain floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas”.
“Our investigator documented the presence of leaks in the form of water stains and ceiling damage in the parenteral manufacturing area personnel corridor,” the US health regulator said.
The FDA investigator observed buckets with water collected from ceiling leaks and other leaks in this manufacturing area, it added.
Besides the company failed to routinely inspect according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical…including computers, used in the manufacture, processing, packing, and holding of a drug product, USFDA noted.
“Your firm failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel,” it added.
These examples are serious CGMP violations, USFDA said.
“Your quality system does not ensure the quality, safety, and effectiveness of your drug products. It is essential that executive management systematically improve their oversight of manufacturing quality to ensure sustainable quality assurance,” it added.
Until the company completes all corrections and the USFDA has confirmed compliance with CGMP, the regulator may withhold approval of any new applications or supplements listing, it said.
“We may also refuse admission of articles manufactured at Sun Pharmaceutical Industries Halol plant,” it added.
The warning letter follows inspection of the Halol facility in September 2014 by US Food and Drug Administration (USFDA) inspectors.
Sun Pharma shares today ended at Rs 791.05 apiece on the BSE, up 3.52 per cent from previous close.