News about GMP/cGMP


ICH Q2/Q14: Final Concept Paper for Analytical Procedure Development

The International Council for Harmonisation (ICH) has published the final concept paper for ICH Q14 (Analytical Procedure Development) on its website. In the course of the preparation of this new guideline, ICH Q2 (Validation of Analytical Procedures) will also be revised. It will be adapted to the state of the art to include modern analytical methods in the future. Both guidelines are intended to supplement the existing documents ICH Q8 - ICH Q12.


ICH Q14 is primarily intended to support applicants in not submitting analytical validation results in isolation but in presenting them together with a present performance evaluation based on corresponding analytical development results. This applies in particular to modern analytical methods. ICH Q14 should offer harmonized scientific approaches for analytical method validation as well as support the communication between authorities and industry.

Furthermore, the  Expert  Working  Group  for this task shall  potentially  determine  the  feasibility  to  combine  both documents into one for simplification and clarity.

Draft documents should be available in spring 2020. Final versions are supposed to follow in spring 2021.


ICH Q2/Q14: Business Plan and Concept Paper