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nvs ☆ India, 2009-02-25 06:04 (6329 d 07:48 ago) Posting: # 3287 Views: 3,482 |
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Dear all, We got some ULOQ concentrations during the study sample analysis. We repeated the samples under the code of Upper limit of quantification. In that batch (repeated batch) we analyzed other repeats like IS variations etc... & we put some DQCs (dilution integrity quality control samples). In that batch everything was ok, and batch was accepted. But the DQC samples were not meeting the specification. But the repeated concentrations (ULOQ repeats) were with in the calibration range. So again ULOQ samples were taken for repeat. So which code has to given for that samples. During the second repetition they are not ULOQ's. We repeated because of failure of DQC's. -- Edit: Category & subject line changed. [Helmut] |
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Geokad ☆ Canada, 2009-02-26 20:36 (6327 d 17:15 ago) @ nvs Posting: # 3291 Views: 2,703 |
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Dear nvs, ❝ So which code has to given for that samples. ❝ During the second repetition they are not ULOQ's. We repeated because of ❝ failure of DQC's. You can use the code for samples lost in processing or the code for inadequate dilution. Whichever code you use, you should have an SOP detailing all the codes that you use and when to apply them. — Regards, Geokad |
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nvs ☆ India, 2009-02-27 06:15 (6327 d 07:36 ago) @ Geokad Posting: # 3292 Views: 2,706 |
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Dear Geokad, Thank you for your reply. We have the codes, related to this issue is o Processing error, o System failure, o Above upper limit of quantification (ULOQ) and o Others (for other repeats which is not defined in the SOP) etc... So I think... It's not ULOQ because it is within the calibration range. (second time repeat analysis) It's not system failure because rest of the batch was passed. So is it comes under either processing error or others. (we already proved dilution integrity in validation itself)  Thank you Regards nvs |
Ing. Helmut Schütz