ICH Q14 and Q2(R2): How Analytical Methods Are Now Developed and Validated
Two harmonised guidelines adopted in November 2023 describe analytical procedures as a lifecycle — from defining what a method must measure to validating and maintaining it. Here is what changed.
In November 2023 the International Council for Harmonisation (ICH) adopted two closely linked guidelines: ICH Q14, on analytical procedure development, and a complete revision of ICH Q2, published as Q2(R2), on validation of analytical procedures. Together they frame analytical methods as something designed, validated and maintained over a lifecycle rather than validated once and left unchanged.
ICH Q14: development and the Analytical Target Profile
ICH Q14 describes a minimal (traditional) approach and an enhanced approach to procedure development. The guideline states that the minimal approach remains valid, while elements of the enhanced approach can provide additional knowledge about how a procedure performs. A central concept is the Analytical Target Profile (ATP): a description of what a procedure needs to measure and the performance required for its intended purpose.
ICH Q2(R2): validation aligned with development
The revised Q2(R2) was rewritten to include more recent applications of analytical procedures and to align with Q14. It describes validation as providing sufficient evidence that a procedure meets its objectives, expressed through performance characteristics such as specificity/selectivity, accuracy and precision over the reportable range. It also notes that system suitability tests are an integral part of procedures and that robustness is typically evaluated during development, before the formal validation study.
The guideline expects a validation protocol to be prepared before the study and the results to be summarised in a validation report.
Why this matters for research materials
These guidelines are written for pharmaceutical products, not research chemicals. They are nonetheless the most widely recognised reference for what makes an analytical result reliable. When a supplier reports purity or identity data, asking how the method was developed and whether its specificity was demonstrated is a direct application of the principles these documents set out.
Scientific references
Primary source: ICH Q14 Analytical Procedure Development — Final version adopted 1 November 2023 — Source published 1 November 2023
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