USP Proposes Major Revision to Chapter <1225> on Analytical Procedure Validation

The U.S. Pharmacopeia has released a proposed revision to General Chapter <1225>, now titled Validation of Analytical Procedures, in Pharmacopeial Forum PF 51(6). The update broadens the chapter’s scope to encompass both compendial and noncompendial methods while aligning with ICH Q2(R2) and USP <1220> on the analytical procedure life cycle. It also complements the new USP <1221> on ongoing performance verification. Key changes emphasize “Reportable Result” as the definitive output for decision-making and “Fitness for Purpose” as the core validation objective. The revision integrates statistical intervals for assessing precision and accuracy, highlights replication strategies based on uncertainty control, and connects acceptance criteria to performance requirements. The reorganized structure includes sections on validation principles, strategies, and methodologies, along with four technical appendices. Related chapters—such as <1210>, <1033>, and <1226>—may also be impacted. Stakeholders can submit comments on the proposal until January 31, 2026, via the Pharmacopeial Forum.

11-11-2025