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Registerbatch reinjection when QC failed [Bioanalytics]
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
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
Complete thread:
- batch reinjection when QC failedvish14184 2010-08-07 20:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- batch reinjection when QC failed Ohlbe 2010-08-10 17:57
- batch reinjection when QC failed keshav khude 2010-08-13 09:46
- batch reinjection when QC failed Ohlbe 2010-08-10 17:57
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