The new ICH Guideline Q2 Validation of Analytical Procedures (Revision 2) - Live Online Training Mission accomplished?

During the ICH Assembly Meeting on 31 October and 01 November 2023, the final ICH guidelines Q2(R2) and Q14 were adopted, after more than 3000 comments have been received each concerning the draft guidelines published in March 2022.

During this Live Online Training, the participants will learn what aspects have changed and what is new in the revised Q2 guideline. A critical discussion will be provided whether the gaps and uncertainties of the old guideline from 1994 are sufficiently addressed, in particular considering the new USP General Information Chapter <1220> Analytical Procedure Life Cycle. Some of the examples provided in Annex 2 will be critically discussed and evaluated.

Since the implementation of the ICH Guideline Q2 Validation of Analytical Procedures in 1994, many topics emerged in the pharmaceutical area, in particular in manufacturing, towards a holistic lifecycle management, such as the ICH Guidelines Q8-12, or the FDA and EU process validation guidelines. Although ICH Q2 served its role to harmonise terminology and basic requirements with respect to analytical validation, some gaps and uncertainties remained and became more and more obvious in the light of the recent developments. For example, the major focus of Q2 on chromatographic methods, the lack of clarity what suitability means (acceptance criteria linked to the measurement requirements for the respective Critical Quality Attribute), or the confusion between the response function (calibration model) and linearity of the analyte in the sample (accuracy). Consequently, in November 2018, a concept paper was published describing the area of improvements for a revision of the Q2 Guideline as well as the introduction of a new, related ICH Guideline Q14 on Analytical Procedure Development.

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