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ramya ☆ 2010-04-13 15:45 (5919 d 06:29 ago) (edited on 2010-04-13 16:04) Posting: # 5109 Views: 3,451 |
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Dear All, kindly can any body let me know, in BA/BE can we reinject the sample due to bad peak shape in first run. example - CC and QCs and along with subjects samples are analyzed, later on due to bad peak shape run is rejected and reinjected after washing the column. and batch accepted in this case they have proved the re- injector reproducibility also for 72hr. can we accept the result of this reinjected batch? are sample should be reanalyzed? kindly clarify at the earliest. regards RS -- Edit: category changed [Ohlbe] |
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Ohlbe ★★★ France, 2010-04-13 18:09 (5919 d 04:05 ago) @ ramya Posting: # 5110 Views: 2,788 |
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Dear Ramya, I would consider this to be acceptable. Make sure that you keep the chromatograms of the initial run, to be able to demonstrate that you indeed had a poor chromatography for this run (and that you did not reinject it just because the QCs fail, which any inspector will want to check  ).This would be in line with EMA's draft guideline on method validation (see lines 460 - 463). Regards Ohlbe — Regards Ohlbe |
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ramya ☆ 2010-04-14 08:19 (5918 d 13:55 ago) @ Ohlbe Posting: # 5113 Views: 2,777 |
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Dear Ohlbe, Thank you for the fast reply. Your answer is clear to me. regards, ramya |
Ing. Helmut Schütz