Japanese–English glossary
Robustness
頑健性gankensei
The capacity of an analytical procedure to remain unaffected by small, deliberate variations in its parameters, such as column temperature, mobile phase pH, incubation time or reagent lot. Under ICH Q14 and Q2(R2), robustness is normally evaluated during method development. For cell-based bioassays it covers variation in cell passage, incubation time and reagent lots. The results inform system suitability criteria and the allowed operating ranges of the method. Japanese documents also apply the word to manufacturing processes that tolerate variation in equipment, operators and starting materials.