Glossary

Robustness [MDCG 2022-2]

MDCG

The robustness of an analytical procedure means the capacity of an analytical procedure to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
Source: ICH Q2(R1)– Validation of analytical procedures

 

[Definition according to MDCG 2022-2 No. 4]