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pb070681 ☆ 2007-10-12 19:08 (6813 d 06:02 ago) Posting: # 1183 Views: 5,610 |
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Is it mandatiry to prepare differnt stock solution to prepare calibration curve and quality control sample ? if yes..... Why? Regrards pramod |
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Ohlbe ★★★ France, 2007-10-12 20:16 (6813 d 04:54 ago) @ pb070681 Posting: # 1184 Views: 4,533 |
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Dear Pramod, According to the Standards and QC samples can be prepared from the same spiking stock solution, provided the solution stability and accuracy have been verified. You can use the same stock solution for calibration and QC samples. But you have to show that the stock solution was prepared correctly and that its concentration is accurate. Which is usually done by comparing it to another, independently prepared stock solution... Regards Ohlbe Edit: Link corrected for FDA’s new site. [Helmut] |
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chiragkhatri ★ India, 2007-10-17 12:37 (6808 d 12:33 ago) @ Ohlbe Posting: # 1207 Views: 4,447 |
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Dear Pramod, I agree to Ohlbe, but if u go through FDAs bioresearch monitoring programme (link) Access attachment A, Part III ( ANalytical data and operations), go to 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 Regards Chirag -- Edit: Full quote removed. Please see this post! [HS] |
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Ohlbe ★★★ France, 2007-10-18 20:10 (6807 d 05:00 ago) @ chiragkhatri Posting: # 1214 Views: 4,358 |
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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 |
Ing. Helmut Schütz