ICH Q2(R2): Validation of Analytical Procedures

ICH Q2(R2) presents a discussion of the characteristics to be considered during the validation of analytical procedures included as part of registration documentation within the ICH region. Validation is defined as demonstration that the procedure “is suitable for its intended purpose”. In November 2018, a concept paper was published describing the areas for improvements for a revision of the Q2 Guideline as well as the introduction of a new, related ICH Guideline Q14 on Analytical Procedure Development, to reflect the developments since 1994, such as quality-by-design principles, or lifecycle aspects. At the ICH Meeting in Prague, 31 October and 1 November 2023, the two guidelines reached Step 4 and were adopted by the ICH Assembly Regulatory Members. Keeping with the structure of the revised ICH Q2(R2) guideline, the main aspects are summarised in the chapter, followed by a section “NEW”, emphasizing clarifications, additions, new requirements etc., and by a section “INTERPRETATION”, where missed aspects, context, interpretations of the guideline text, and mistakes are discussed (from the perspective of the author).