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RegisterAn example of IS response. Need your helps. [Bioanalytics]
In agreement with all the opinions of the panel.
To keep my views
To keep my views
- Bracketing of CC standards might have resolved the issue for investigation.
- ISR results might be supportive.
- Apart from acceptance criteria mentioned, SOP should define criteria for number of such samples showing Out of trend (OOT) for single run as well as overall runs so that there will be provision for repeating samples or batch.
- This situation can be handled with proper investigation in areas like:
- Instrument performance in continuous to such run either through multiple equilibration injections or through PPG showing stable or increased response.
- Extraction method used, performed in single or different processing batches, same or different lots of cartridges and solutions used, single or multiple analysts involved in processing, any changes to the solutions on the system made, any changes to the needle set point made in MS during the run, run size evaluation met for the same number of samples in this run.
Complete thread:
- An example of IS response. Need your helps. Shuanghe 2020-05-26 12:56 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
- An example of IS response. Need your helps. Shuanghe 2020-05-26 16:32
- An example of IS response. Need your helps. Ohlbe 2020-05-26 17:46
- An example of IS response. Need your helps. Ohlbe 2020-05-26 14:42
- Placement of CC Helmut 2020-05-26 15:35
- An example of IS response. Shuanghe 2020-05-26 16:32
- An example of IS response. Ohlbe 2020-05-26 17:27
- Placement of CC Ohlbe 2020-05-26 17:32
- Placement of CC Helmut 2020-05-26 19:03
- Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
- Duplicate LLOQ and ULOQ Helmut 2020-05-27 16:30
- Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
- Placement of CC Helmut 2020-05-26 19:03
- An example of IS response. Shuanghe 2020-05-26 16:32
- Placement of CC Helmut 2020-05-26 15:35
- An example of IS response. Need your helps. ElMaestro 2020-05-26 15:44
- An example of IS response. Need your helps.ksreekanth 2020-07-06 13:37
- Trend analysis as per recent USFDA guideline dshah 2020-08-01 07:32
- Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
- Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
- Deviation from the mean response Helmut 2020-08-07 13:28
- Only for QCs; encouraged ≠ required Shuanghe 2020-08-03 13:56
- Broken-stick regression Helmut 2020-08-04 18:04
- Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
- Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
Ing. Helmut Schütz