FDA publishes Q2(R2) and Q14 Guidelines

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

As already reported a few months ago, 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 2023, the final documents were made available for download by the ICH. In January 2024, the European Medicines Agency (EMA) published the new ICH Q14 as Step 5, with the 14 June 2024 as the date for coming into effect.

In March 2024, the U.S. Food and Drug Administration (FDA) announced the availability of both documents on its website.

On the website, it says as follows: "The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance entitled “Q2(R2) Validation of Analytical Procedures” provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data. The guidance entitled “Q14 Analytical Procedure Development” provides harmonized guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based postapproval change management. [...]"

To download the documents and for information on how to comment, please visit the FDA website:

• Q2(R2) Validation of Analytical Procedures
• Q14 Analytical Procedure Development