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

posted by ElMaestro  – Belgium?, 2018-07-10 18:28 (808 d 15:21 ago) – Posting: # 19027
Views: 1,223

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.

I could be wrong, but...

Best regards,

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

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