New paper published on Analytical Procedure Validation
Phil Borman, GSK, has been an established speaker at JPAG meetings for a number of years, most recently presenting on the 'Regulatory state of the nation for Analytical Procedure Validation incorporating standards, expectations, concepts and proposals for change' in October 2023. Of interest to JPAG members, he has recently published a paper with the USP on the topic of Ongoing Analytical Procedure Performance Verification: Click here

It is believed that this paper nicely compliments ICH Q14 providing useful guidance building on the Section 6 paragraph: “Ongoing monitoring of selected analytical procedure outputs is recommended to look for any trends, in line with PQS expectations. Review of analytical procedure outputs facilitates the procedure lifecycle management and enables proactive intervention to avoid failures.” Thoughts are that this could also provide a useful approach that can help support greater flexibility (e.g. through monitoring impact of changes) across the lifecycle.