ICH: Parallel Guidances Q2(R2)/Q14 on Analytical Procedures adopted

The Assembly of the International Council for Harmonisation (ICH) adopted the revised Q2(R2) Guideline on the Validation of Analytical Procedures and the new Q14 Guideline on Analytical Procedure Development. They jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products.

Both documents reached Step 4 of the ICH process, are now harmonised, and represent the current state of science and technology. This was announced following the ICH's 31 October 2023 meeting in Prague. Draft documents for the guidelines were first presented in March 2022 (we reported).

• The scope of the revision of ICH Q2(R1) includes validation principles that cover the analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR, or MS) some of which often require multivariate statistical analyses.
• The new guideline Q14 provides principles relating to the description of the analytical procedure development process. It 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.

An Expert Working Group (EWG) will now transition to an Implementation Working Group (IWG) to develop training materials for both guidelines. Furthermore, the guidelines will be implemented and published shortly on the ICH website. This step is currently pending. The Q2(R2) and Q14 guidelines are intended to complement the ICH guidelines Q8 to Q12, as well as the current ICH guideline Q13 for continuous manufacturing.

Source:

ICH: Press Release on ICH Assembly Meeting, Prague, Oct 2023