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A lovely general sentence in an FDA warning letter [GxP / QC / QA]

posted by ElMaestro - Denmark, 2018-07-10 18:28  - Posting: # 19027
Views: 438

Hi all,


"Your acceptance of the passing results based on an assumed laboratory error was insufficient to invalidate the original failing result and conclude the investigation."


This little sentence portrays a general issue in the industry at the moment. Failure is not an option.
How many failed dissolution tests have you seen repeated this way? How many failed stabilities? How many failed A/P runs? And so forth.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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