Calibrators & QCs requirement in all validation runs (latest USFDA BMV) [Bioanalytics]

posted by meet.shah – Jordan, 2018-09-05 09:19 (863 d 06:24 ago) – Posting: # 19239
Views: 1,003

Dear Members,
I am little confuse :confused: 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?

Edit: Category changed; see also this post #1[Helmut]

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