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RegisterReporting QCs [Bioanalytics]
Dear Harish,
Also have a look at the report of the "Crystal City III" FDA/AAPS workshop, page E36, under "Analytical/validation reports should include", point 2.
QC data from validation runs that only failed to meet QC acceptance criteria with no assignable cause for failure should be included in the precision and accuracy estimation.
If you have to include data from failing runs, excluding some results from validated runs is really not an option... Or at least have two versions of the tables in the validation report, one with and one without the failing results, as suggested.
Regards
Ohlbe
Also have a look at the report of the "Crystal City III" FDA/AAPS workshop, page E36, under "Analytical/validation reports should include", point 2.
QC data from validation runs that only failed to meet QC acceptance criteria with no assignable cause for failure should be included in the precision and accuracy estimation.
If you have to include data from failing runs, excluding some results from validated runs is really not an option... Or at least have two versions of the tables in the validation report, one with and one without the failing results, as suggested.
Regards
Ohlbe
Complete thread:
- Reporting Failed QCs Dr. Harish L. Rao 2007-08-30 08:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reporting QCs Helmut 2007-08-30 12:05
- Reporting QCsOhlbe 2007-08-31 10:46
- Reporting QCs Charl 2007-09-02 15:11
- Reporting QCs Ohlbe 2007-09-02 23:50
- Reporting QCs Charl 2007-09-03 10:13
- Precision of incurred samples Ohlbe 2007-09-03 10:20
- Problematic incurred samples guidelines Helmut 2007-09-03 19:49
- Precision of incurred samples Ohlbe 2007-09-03 10:20
- Reporting QCs Charl 2007-09-03 10:13
- Reporting QCs Ohlbe 2007-09-02 23:50
- Reporting QCs Charl 2007-09-02 15:11
- Reporting QCsOhlbe 2007-08-31 10:46
- Reporting QCs Helmut 2007-08-30 12:05
Ing. Helmut Schütz