Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.
News|Articles|October 21, 2026
Nitrosamine Problems and Industry Solutions: PharmTech Explained
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
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In April 2026, a generic manufacturer pulled 165,000 more bottles of duloxetine from shelves, the ninth recall of the antidepressant in 2 years. Each was a voluntary Class II action tied to excess N-nitroso-duloxetine, a nitrosamine impurity classified as a probable human carcinogen. The latest episode of PharmTech Explained builds on
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