La calidad desde el diseño ofrece ventajas sobre modelos previos de aseguramiento de la calidad, siendo útil en sectores donde la calidad signifique diferenciación y la flexibilización de los procesos estimule el mejoramiento continuo y la innovación. Como una contribución para facilitar su implementación en la industria farmacéutica en Colombia, en el presente artículo se analizan las circunstancias que la originaron. Igualmente, partiendo de un estudio de literatura especializada, se explica su importancia en el desarrollo de productos y se proponen algunos aspectos metodológicos para su puesta en práctica. La evidencia reportada sugiere que esta nueva visión de la calidad es una estrategia que genera confianza en clientes, industria y organismos reguladores, respecto a la calidad de los productos farmacéuticos.Quality by design offers advantages over previous quality assurance models, being useful in areas where
quality means the differentiation and implementation of flexible processes to stimulate continuous
improvement and innovation. As a contribution to making quality by design easier to implement in
the Colombian pharmaceutical industry, this paper discusses why this concept was originated. Likewise,
based on a literature analysis, the noteworthiness of quality by design when products are being developed
is discussed, and methodological strategies for its accomplishment are proposed. The reported evidence
suggests that quality by design builds consumer, industrial and regulatory confidence on the quality of
pharmaceutical products
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