Log in
Register|
haydonat ☆ Turkey, 2012-01-30 15:27 (4869 d 19:05 ago) (edited on 2012-01-30 18:13) Posting: # 8017 Views: 4,484 |
|
|
Dear all, We have 8 calibration standards in each study batches. If three of CC standards are out of range according to guidance (EMA), should we reject the batch directly or should we excluded the highest deviation CC first than calibration curve re-calculated again. If other CCs are still failing, the one with the highest deviation is excluded and so on? Thank you for your interest. Best regards. Edit: category changed [Ohlbe] |
|
Ohlbe ★★★ France, 2012-01-30 19:11 (4869 d 15:21 ago) @ haydonat Posting: # 8018 Views: 3,815 |
|
|
Dear Haydonat, I would consider both approaches to be acceptable, though I would personally prefer the second. Define the process in your SOP. Regards Ohlbe — Regards Ohlbe |
|
haydonat ☆ Turkey, 2012-01-31 16:02 (4868 d 18:29 ago) (edited on 2012-01-31 17:58) @ Ohlbe Posting: # 8026 Views: 3,956 |
|
|
Thank you for your response  But I want to ask another case we have 8 calibration standards and 6 of them out of range  Actually if we look at the areas of analyte only one value of CC is not suitable. If we exclude this CC, all of the CCs were in range. But if we look the deviations of CC samples we exclude highest deviation of CC firstly than one more CC sample is out of range and again this value excluded. But one of the CC sample which have highest deviation and firstly excluded is in the range At the result we exclude the two CC samples but one of them is in range. What do you suggest us about this situation? Regard Hale 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] |
|
Ohlbe ★★★ France, 2012-01-31 19:05 (4868 d 15:27 ago) @ haydonat Posting: # 8031 Views: 3,832 |
|
|
Dear Hale, ❝ But if we look the deviations of CC samples we exclude highest deviation of CC firstly than one more CC sample is out of range and again this value excluded. But one of the CC sample which have highest deviation and firstly excluded is in the range ❝ At the result we exclude the two CC samples but one of them is in range. Hey, I had not come across that situation before... It confirms the need to look at the graph, not just at the digits. No idea what I would do, I would need to look at the data. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz