ICH adopts final Text of Q2(R2) and Q14 Guidelines

The Assembly of the International Council for Harmonisation (ICH) met in person on 31 October and 01 November 2023 in Prague, Czech Republic. During this meeting, the ICH Q2(R2) Revised Guideline on "Validation of Analytical Procedures” and the new ICH Q14 Guideline on “Analytical Procedure Development” were adopted by the ICH Assembly Regulatory Members.

ICH Q2(R2)

ICH Q2(R2) presents elements for consideration during the validation of analytical procedures included as part of registration applications. It provides guidance on selection and evaluation of the various validation tests for analytical procedures.

In a press release dated 08 November 2023, the ICH points out that "the scope of the revision of ICH Q2(R1) includes validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses."

ICH Q14

ICH Q14 describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. "This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures."

Live Online Training on 30 January 2024

The ECA organizes a Live Online Training on 30 January 2024. The participants will learn what aspects have changed and what is new in the revised Q2 guideline. Dr Joachim Ermer will further provide a critical discussion 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".