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Aplicación de la Incertidumbre de Medición Analítica y Consideraciones hacia Estrategias de Control de Calidad de

Michael A Zompa¹, Dolee Merai¹, Paul Oram¹

¹Analytical Research and Development, MRL, Merck & Co., Inc., Rahway, New Jersey 07065, United States.

Analytical chemistry

|December 29, 2025

Abstract:

Guidance documents ICH Q14 and USP <1220> discuss the uncertainty associated with measurements and its impact on decisions regarding pharmaceutical materials. Through case studies, we demonstrate an approach for setting acceptance limits for analytical test results accommodating analytical measurement uncertainty, establishing an integrated control strategy, and reinforcing confidence around material quality.

Palabras clave:

incertidumbre de medición control de calidad farmacéutico límites de aceptación estrategias de control materiales farmacéuticos

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