ICH Guidelines Q2(R2) "Validation of Analytical Procedures" and ICH Q14 "Analytical Procedure Development" published

As already reported, 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.

Shortly before Christmas, the final documents were made available for download on the ICH website.

ICH Q2(R2)

The new 36-page ICH Q2(R2) is divided into the following main chapters:

• 1. Introduction
• 2. General considerations for analytical procedure validation
• 3. Validation tests, methodology and evaluation
• 4. Glossary
• 5. References
• 6. Annex 1: Selection of validation tests
• 7. Annex 2: Illustrative examples for analytical techniques

ICH Q14

The new ICH Q14 comprises 40 pages, including the title page and table of contents, and is divided into the following sections:

• 1. Introduction
• 2. General considerations for analytical procedures
• 3. Analytical target profile
• 4. Knowledge and risk management in analytical procedure
• 5. Evaluation of robustness and parameter ranges of analytical procedures
• 6. Analytical procedure control strategy
• 7. Lifecycle management and post-approval changes of analytical procedures
• 8. Development of multivariate analytical procedures: additional considerations
• 9. Development of analytical procedures for real time release testing: additional considerations
• 10. Submission of analytical procedure related information
• 11. Glossary
• 12. References
• 13. Annex

Document Comparison

We have prepared document comparisons (Q2(R1) / Q2(R2) and Q14 Draft version March 2022 / Q14 Final version), which are available for download in the members' area of the ECA Analytical Quality Control Group.

For further information and to apply for a free membership, please visit the group's website.

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 have been sufficiently addressed, in particular considering the new USP General Information Chapter <1220> "Analytical Procedure Life Cycle".