Revised ICH guideline Q2(R1) on Validation of Analytical Procedures

In January 2024, the European Medicines Agency (EMA) published the revision of the ICH Q2 guideline on the validation of analytical procedures, together with the new ICH Q14 guideline on analytical method development. The date for coming into effect for both documents is 14 June 2024.

The ICH Q2 guideline -in collaboration with ICH Q14- addresses the development and validation processes for assessment of the product quality throughout its lifecycle. Both guidelines are designed to complement existing ICH Q8 to Q13 guidelines. 

The outline of the new ICH Q14 guideline has previously already been posted on our LinkedIn. This post will now focus on the revised ICH Q2 guideline.  

ICH Q2 outlines validation considerations for analytical procedures within registration applications and offers guidance on the selection and evaluation of various validation tests. It includes validation principles that cover spectroscopic data (e.g. NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. 

Moreover, the guideline intends to enhance regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval. It will also benefit post-approval changes to analytical procedures.

Some key changes of the revised guideline include:

• Utilizing data from development studies
• Allowing reduced validation for established procedures 
• Multivariate calibration and lifecycle validation concepts to align with principles of ICH Q14
• Updated terminology and performance characteristic tables
• Definitions aimed at harmonizing terminology across regulatory authorities
• Illustrative examples in Annex 2

Overall, both ICH Q2 and Q14 aim to develop robust analytical procedures suitable for the intended purposes while offering flexibility in approaching and enhancing regulatory compliance.

If you’re developing and/or want to validate an analytical method and would like some guidance with respect to the ICH Q2 and Q14 guidelines, feel free to contact us via the Contact form.