Section 12.7 of Q7A states, “the degree of analytical validation performed should reflect the
purpose of the analysis and the stage of the API production process”. For example, a pH
measurement used for in-process control would generally not be validated. The pH meter would
be properly qualified/calibrated and standard solutions used would demonstrate that the pH meter
is functioning properly. However, there would not be a formal analytical method validation.
Additional guidance is provided in ICH Q3A and USP.
