Desarrollo e implementación de nuevos métodos analíticos en el marco estratégico de la calidad analítica por diseño y la gestión del ciclo de vida
DOI:
https://doi.org/10.62035/rca.5.65Palabras clave:
control de calidad, métodos, preparaciones farmacéuticasResumen
El marco estratégico de la calidad analítica por diseño (AQbD) provee de herramientas poderosas para el desarrollo y la implementación de métodos analíticos eficientes y robustos destinados al control de calidad de materias primas y productos farmacéuticos. Por otro lado, la gestión del ciclo de vida del método analítico asegura que los resultados obtenidos durante el uso rutinario del mismo cumplan con especificaciones de calidad en todo momento. Basado en la gestión del riesgo de la calidad, este nuevo paradigma propone el uso de diseños estadísticos de experimentos para generar un conocimiento profundo sobre el desempeño de las variables de un método analítico, con el objetivo de encontrar condiciones operativas óptimas. De esta manera, las características de rendimiento de un nuevo método analítico ya no solo se evalúan como una tarea final en la validación formal del método, sino que se establecen y optimizan durante el desarrollo del mismo. Para esto se siguen objetivos predefinidos, los cuales se proponen de acuerdo al alcance del método y al perfil de calidad del producto. Estos objetivos incluyen la definición de los errores máximos permitidos en el resultado informable. En esta revisión bibliográfica se describen y dan ejemplos de los conceptos y herramientas más importantes relacionados a la AQbD. Se presentan además algunos casos reales en los que se aprecia el beneficio de aplicar esta estrategia para resolver problemas analíticos complejos, optimizando el tiempo y recursos invertidos.
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Derechos de autor 2024 María Mercedes De Zan, Yamile Soledad Caro
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