Robustness

The degree to which an analytical procedure is unaffected by small deliberate variations in the test conditions.

Related sections

ICH Q2(R2) §§2–4 21 CFR 211.160 21 CFR 211.165

Related terms

Analytical Procedure ValidationRange121 casesWorst Case22 cases

Real inspection findings

See 2 findings that mention this term

Source

식품의약품안전처, 「알기 쉬운 GMP 용어집」, Robustness