Synopsis
Amid growing scrutiny from the U.S. FDA over documentation practices and contamination issues, Granules India is reinforcing its manufacturing framework. The company is turning to advanced digitization and automating record management to bolster data accuracy and compliance. By instituting these reforms, Granules India is proactively tackling regulatory challenges while ensuring excellence in product quality across all facilities.
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Granules India is increasing oversight at its manufacturing facilities and digitising documents after the U.S. drug regulator flagged violations, including issues with record-keeping and contamination control practices, at its largest plant, a top executive said.
The company, which is globally one of the largest paracetamol makers and a major player in the active pharmaceutical ingredients market, derives a bulk of its revenue from the U.S.
Last year, the Food and Drug Administration flagged violations in good manufacturing practices, equipment cleaning and contamination controls at the plant in the southern Indian state of Telangana. The firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment, the FDA had said, adding that a large amount of torn data records were found in 15 plastic waste bags.
While the warning did not halt production, it could temporarily affect FDA approval of new products manufactured at the site.
Granules has 10 manufacturing plants, of which seven are in India, two in the U.S. and one in Europe.
The drugmaker will move its operations logbooks, batch manufacturing records and badge cards online over the next few months to reduce data-related regulatory risks, its executive director, Priyanka Chigurupati, told Reuters in an interview last month.
“We expect the FDA to come anytime,” Chigurupati said.
The company raised the frequency of so-called gemba walks, where managers observe manufacturing practices to identify bottlenecks, as part of its standard operating procedure at the facility.
“So whenever there’s an issue, we stop and don’t move forward,” she said, adding that doing so will avoid issues with product quality. The firm will focus on implementing automation of data collection and tightening controls across facilities, and has set aside a ‘certain amount’ of capital expenditure, she said, without giving further details.
“We hadn’t thought about it (automation and controls) earlier, but now we are, and it’s high time we did, so we’re really adapting and adopting those practices,” Chigurupati said.