Jane Weitzel is an independent consultant and chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality.
Evolution of Analytical Procedure Validation Concepts: Part II
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
Evolution of Analytical Procedure Validation Concepts: Part I
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.