Jane Weitzel (USP)
ArticleAdvancements and knowledge gaps in ICH Q2(R2)
In this article, experts from USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. They highlight areas that would benefit from additional guidance and compare how the latest ICH Q14/Q2(R2) guidelines align with US pharmacopeial approaches.