European Pharmaceutical Review Article on ICH Q2(R2)

In the European Pharmaceutical Review, a new article entitled "Advancements and knowledge gaps in ICH Q2(R2)" was published.

The publication was written by Amanda Guiraldelli Mahr, Joachim Ermer, Phil Bormanm, Jaime Marach, Pierre Lebrun, Jane Weitzel, Jean-Marc Roussel, and Christopher Burgess. With Christopher Burgess and Joachim Ermer the authors include members of the ECA Analytical Quality Control Group Advisory Board.

Starting with the relationship between ICH Q14 and Q2(R2), the authors take a critical look at the new aspects incorporated in ICH Q2(R2). The concepts of selectivity and specificity, range and response, as well as accuracy and precision are discussed in more detail. The authors also identify areas needing additional guidance and compare how the latest ICH Q14/Q2(R2) guidelines align with US pharmacopeial approaches.

The authors conclude that "the revised ICH Q2(R2) guideline updates terminology and broadens the scope of techniques/products applicable, improving validation requirements for uni- and multivariate analytical procedures, while maintaining traditional approaches." It also says that "while both Q14 and Q2(R2) align with principles outlined in USP <1220>, further clarity and alignment between the two guidelines are needed to promote a comprehensive lifecycle approach."

The article was published in European Pharmaceutical Review, Vol. 29, No. 2, 2024.