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RegisterQC sample levels in each run [Bioanalytics]
Dear All,
Could anyone explain more about following sentence in EMA Guideline?
"At least 2 QC sample levels should fall within the range of concentrations measured in study samples"
Thing is, our inspector concluded that if 2 QC sample levels e.g. MQC and HQC exceeded the maximum concentration obtained from this analytical run, this run will be rejected because only LQC was incorporated into this run while we think on the other hand that 2 QCs should cover or closely bracket all study sample concentrations not specific for each analytical run.
Please help me out to get thing more clear & Thanks a millions in advance!
TK
Thailand
Edit: Category changed. [Helmut]
Could anyone explain more about following sentence in EMA Guideline?
"At least 2 QC sample levels should fall within the range of concentrations measured in study samples"
Thing is, our inspector concluded that if 2 QC sample levels e.g. MQC and HQC exceeded the maximum concentration obtained from this analytical run, this run will be rejected because only LQC was incorporated into this run while we think on the other hand that 2 QCs should cover or closely bracket all study sample concentrations not specific for each analytical run.
Please help me out to get thing more clear & Thanks a millions in advance!
TK
Thailand
Edit: Category changed. [Helmut]
Complete thread:
- QC sample levels in each runTK 2015-09-15 12:22 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- QC sample levels in each run Ohlbe 2015-09-15 12:54
- QC sample levels in each run TK 2015-09-17 05:01
- QC sample levels in each run Ohlbe 2015-09-17 10:35
- QC sample levels in each run Ladi 2015-09-17 13:58
- Concentration of HQC Ohlbe 2015-09-17 14:48
- QC sample levels in each run Ladi 2015-09-17 13:58
- QC sample levels in each run TK 2015-09-21 04:57
- QC sample levels in each run Ohlbe 2015-09-17 10:35
Ing. Helmut Schütz