FAQ: What You Need to Know About Analytical Method Validation (LOB, LOD, LOQ, Acceptance Criteria, and Equivalence Testing)

Validation demonstrates that an analytical procedure is fit for its intended purpose, whether that purpose is release testing, stability monitoring, or impurity control. The International Council for Harmonisation’s (ICH) Q2(R2) guideline provides the current framework for this process, and FDA has applied it to regulatory submissions since the guidance took effect in March 2024, alongside its companion guideline, ICH Q14, on analytical procedure development.^1,2