Amanda Guiraldelli

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Amanda Guiraldelli is Scientific Affairs Manager, United States Pharmacopeia, Rockville, MD.

Articles

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

Amanda Guiraldelli;Jane Weitzel

December 20th 2022

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 – Analytical Procedure Life Cycle and Compendial Approaches

Amanda Guiraldelli;Jane Weitzel

November 4th 2022

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.