ICH Q2(R2) and ICH Q14 Analytical Validation

Validation of Analytical Procedures
Q2(R2)

Analytical Procedure Development
Q14

ICH Q2R2 and ICH Q14 Objectives:

This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical Procedure Development. ICH Q2(R2) provides guidance on selection and evaluation of the various validation tests for analytical procedures. This guideline includes a collection of terms and their definitions, which are meant to bridge the differences that often exist between various compendia and documents of the ICH member regulatory authorities. The objective of validation of an analytical procedure is to demonstrate that the analytical procedure is fit for the intended purpose. Further general guidance is provided on validation studies for analytical procedures.