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vish14184 ★ India, 2010-08-07 22:09 (5798 d 16:46 ago) Posting: # 5741 Views: 3,958 |
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Dear All, I would like to know that, 1. In one batch 8 QC is inter spread between unknown sample. During study sample analysis (analytical batch) found that first two QCs are failed due to Analyte area is decrease (Concluded from, Comparison of Analyte area of Calibration standard and failed two QC samples) then, batch was stopped and batch was re injected from beginning after system stabilization. After re-injection, re injected QCs are passing and batch is within acceptance criteria. Can we accept this batch? ISTD response found constant throughout batch. 2. In BE study, if number of batch failure in bio analytical analysis is more (more than 10%) then required to file any investigation for same. Regards, Vishal nakrani |
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Ohlbe ★★★ France, 2010-08-10 19:57 (5795 d 18:57 ago) @ vish14184 Posting: # 5766 Views: 3,214 |
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Dear Vishal, ❝ After re-injection, re injected QCs are passing and batch ❝ is within acceptance criteria. Can we accept this batch? ❝ ISTD response found constant throughout batch. I would avoid this type of practice. The batch was not failed yet when you stopped it (2/8 is less than 33 %). The question could now be: did the QCs first fail by accident, or did they eventually pass by chance ? As you have not identified the reason for failure (the response was lower, but why ?) you will not be able to demonstrate that the second injection is "better" and more reliable than the first. ❝ 2. In BE study, if number of batch failure in bio analytical analysis is ❝ more (more than 10%) then required to file any investigation for same. There is no limit given in the FDA guidance or in the draft EMA guideline. But if you have repeated batch failure you will indeed be expected to investigate why, and to document your investigations. regards Ohlbe — Regards Ohlbe |
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keshav khude ☆ 2010-08-13 11:46 (5793 d 03:08 ago) @ Ohlbe Posting: # 5778 Views: 3,140 |
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Dear All, I agree with Ohlbe, but if any perticular reason initial QC are failing due to instrument response variation needs to be reinject of whole batch. For this required to perform experiment reinjection reproducibility during method validation. Thanks, keshav D.khude Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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