Re: ICH Q2 revision 2 - Yes, thats perfectly true. The initial validation should be regarded as a starting point, i.e. the formal approval of the analytical procedure for practical application. During the practical application, data should be gathered (e.g. RSDs, replicates ranges, control chart data) to verify that the performance is maintained (ongoing monitoring).

Join Dr. Joachim Ermer from Ermer Quality Consulting to learn more about ICH Q2 Revision 2 and the Objectives of Method Development and Validation (Analytical Target Profile).

Watch the On-Demand presentation now: https://bio-qc.com/ich-q2-revision-2-and-method-development-and-validation-objectives-analytical-target-profile/

Plus, don’t miss his expert insights during the panel discussion on Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14.