Run ≠ batch? [Bioanalytics]

posted by dshah – India, 2019-09-23 07:43 (370 d 17:51 ago) – Posting: # 20637
Views: 3,408

» can you please elaborate on the difference between run and batch? I thought that they are synonyms.

Hi All!

I would try to explain to the best of my knowledge.

As per USFDA BMV guideline for Industry in May'2018 on page 16-
" If the bioanalytical method necessitates separation of the overall analytical run into distinct processing batches (e.g., groups of samples processed at distinctly different times or by different analysts), each distinct batch should process duplicate QCs at all levels (e.g., low, middle, high) along with the study samples. Examples might include when the number of samples exceeds the capacity of a 96-well plate or when a solid phase extraction manifold cannot accommodate all samples. See Table 1 for what constitutes an acceptable run based on QC acceptance criteria. A distinct batch or batches in an analytical run may be rejected when it fails to meet QC acceptance criteria, but the remaining batches may pass provided that the analytical run meets the overall QC acceptance criteria."
Acceptance criteria for In-Study Analysis Requirements includes "If the analytical runs consist of distinct processing batches, the QC acceptance criteria should be applied for the whole run and for each distinct batch within the runs."

Thus- in a run- a single batch can pass the acceptance criteria and other may fail too.

Coming to my original point of calibration curve equation-
Say for e.g. the calibration curve equation for a single run (having two batches) can be: f(x)=0.00948370*x-0.00222207 and one run fails to meet the acceptance criteria.
This will require a repeat analysis, and the Calibration curve equation will be not the same for most of the time.
Thus- concentration of unknown samples would be different than the original run.
Over here- @ravuri is asking to run the period in to separate runs- which will definitely have different equation--which may have different concentration than the original concentration -- which may have ultimately impact on final BE statistics.

D Shah

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