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RegisterCalibrators & QCs requirement in all validation runs (latest USFDA BMV) [Bioanalytics]
Dear Members,
I am little confuse
with some lines in USFDA latest BMV guidelines. It will be pleasure if anyone can solve my below question.
On Page.20 Table 1 it is mentioned that A blank (no analyte, no IS, a zero calibrator..., including LLOQ in every run. Same way for QCs on Page.21 it is mentioned that For Other Validation Runs: L, M, and H QCs in duplicates..
Does it mean that Calibrators & QCs required in Selectivity, Specificity, Sensitivity experiments?
Regards,
Meet
Edit: Category changed; see also this post #1. [Helmut]
I am little confuse
with some lines in USFDA latest BMV guidelines. It will be pleasure if anyone can solve my below question.On Page.20 Table 1 it is mentioned that A blank (no analyte, no IS, a zero calibrator..., including LLOQ in every run. Same way for QCs on Page.21 it is mentioned that For Other Validation Runs: L, M, and H QCs in duplicates..
Does it mean that Calibrators & QCs required in Selectivity, Specificity, Sensitivity experiments?
Regards,
Meet
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Calibrators & QCs requirement in all validation runs (latest USFDA BMV)meet.shah 2018-09-05 09:19
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Ing. Helmut Schütz