BRIEFING

 〈1225〉 Validation of Compendial Procedures. This proposal is based on the version of the chapter official as of August 1, 2017. The General Chapters—Measurement and Data Quality Expert Committee is proposing to revise this chapter to align closely with the principles outlined in the International Council for Harmonisation’s guidance ICH Q2(R2)—Validation of Analytical Procedures. It also provides enhanced clarity and direction on critical aspects of analytical procedure validation, particularly those conducted within Stage 2 of Analytical Procedure Life Cycle 〈1220〉. This revision adapts the chapter to its common usage for validation of both noncompendial and compendial analytical procedures and provides connectivity to related USP chapters. In addition, this revision introduces expanded discussions on key concepts—including fitness for purpose, reportable results, and replication strategy—highlighting how they relate to analytical procedure validation. Ensuring the quality of reportable results is emphasized as the primary goal of these validation activities.

 Furthermore, the chapter offers guidance on the use of statistical intervals for assessing performance characteristics such as accuracy and precision. It provides additional direction on a combined approach for the assessment of accuracy and precision. It includes best practices for designing validation studies that align with specific study objectives. Additionally, this chapter introduces approaches for determining acceptance criteria for analytical procedures and technology-driven considerations to support analytical procedures validation.

 Overall, the purpose of this revision is to provide a science-based framework for validating analytical procedures as part of the broader analytical procedure life cycle, offering guidance for both the minimal (also known as traditional) and enhanced approaches to ensure successful validation. Finally, this revision is appearing along with a new chapter, Ongoing Procedure Performance Verification 〈1221〉, which serves as the capstone in the life cycle series and should be considered with this chapter as a basis for monitoring and improving the performance characteristics of a procedure.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCMDQ: M. Marques)

 Case ID—SUB-2242