An example of IS response. Need your helps. [Bioanalytics]

posted by ksreekanth – India, 2020-07-06 11:37 (116 d 02:29 ago) – Posting: # 21653
Views: 3,338

In agreement with all the opinions of the panel.

To keep my views
  1. Bracketing of CC standards might have resolved the issue for investigation.
  2. ISR results might be supportive.
  3. 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.
  4. This situation can be handled with proper investigation in areas like:
    1. Instrument performance in continuous to such run either through multiple equilibration injections or through PPG showing stable or increased response.
    2. 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.
Since only single run showing such trend, to be resolved only through proper initial investigation.

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