ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation – A Step towards Modernizing to Current Standards and Technology?

Recently, the ICH has communicated the intention to develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures (here), where ultimately both documents may be combined into one document.

This is welcome news as ICH Q2(R1) is long overdue for revision (current version finalized November 2005). The current version of ICH Q2(R1) lends itself towards the validation of chromatographic methods and does not provide specific guidance for the validation of non-chromatographic techniques. The planned revised guideline reportedly will cover the validation of spectroscopic techniques and hyphenated methods such as CE-MS, CE-ICP-MS, LC-NMR, GC-MS, LC-MS and will also include guidance for the validation of methods where multivariate statistical techniques are required to define the relationship between instrument output and reference standards

The scope of the Q14 Analytical Procedure Development guideline will include the development of the analytical procedure and will promote the use of Quality by Design principles such that there is a greater understanding of what critical method attributes will have an impact on the reported result. This is critical when considering the change management of the analytical procedure.

The timeframe for the first Expert Working Group meeting on this guideline is expected to be Spring 2019. We are looking forward to the results of this effort, which is long awaited and sorely needed.

If you need any assistance interpreting these new guidances when issued, or advice regarding their application in your firm, please contact James Davidson, Ph.D. at J.Davidson@LachmanConsultants.com or Paul Mason, Ph.D, at P.Mason@LachmanConsultants.com.