Some Pointers From The US FDA On How To Conduct Better Out-Of-Spec Investigations
For Starters, Re-Read The 2006 OOS Guidance
Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.
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This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.
Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.
Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.