Confronting Illusions of Quality in Indian Generics Manufacturing
This article was originally published in The Gold Sheet
Executive Summary
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?
You may also be interested in...
Warning Letters Special Report: Pandemic Drove Focused Inspections, Alternative Approaches
In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.
Why The US FDA Did Not Appreciate Valisure’s Extra Measure Of Protection From Poor Quality Drugs
Unusual citations for DSCSA violations in a recent inspection report and untitled letter from the FDA provide insight into the agency's concerns about the pharmacy that second-guesses the regulatory system it oversees by testing drugs before dispensing them.
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.