US FDA: Sun’s Mohali Plant Dropped Ball On Worker’s Data Integrity Allegations
Was backdating of GMP records part of an effort to move suspect product? FDA investigators found Sun was leaving lots of stones unturned in its effort to find out.
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A decade ago, Dinesh Thakur was able to perceive data integrity issues at Ranbaxy because of his unique position in the company. Today, he’s working to help pharmaceutical companies monitor their global manufacturing networks to detect such issues wherever they might occur.
A sharp increase in data integrity findings has raised questions about the quality of pharmaceutical manufacturing in India. What’s happening and why, who’s responsible, and how can drug makers and the regulatory agencies that watch over them put a stop to it?
U.S. FDA identified several deviations in Ranbaxy’s Mohali oral dosage unit but was particularly concerned about the failure to identify the root cause for manufacturing deviations.