Stock preparation [Bioanalytics]

posted by Ohlbe – France, 2007-10-18 20:10 (6820 d 13:06 ago) – Posting: # 1214
Views: 4,384

Dear Chiragkhatri,

❝ Section E and point 8 states that FDA inspectors do ask for, whether the

❝ control samples and calibrations standards were prepared from different

❝ stock or not


This document is dated October 1999, whis is before the current FDA guideline of May 2001 on bioanalytical method validation. It was prepared from the draft guideline of 1998 and not updated since.

Regards
Ohlbe

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