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La OMS recertifica al laboratorio farmacéutico del Invima por cumplir estándares internacionales
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En una nueva validación de estándares internacionales, la Organización Mundial de la Salud (OMS) recertificó al Laboratorio Fisicoquímico de Productos Farmacéuticos y Otras Tecnologías del Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), destacando su cumplimiento en Buenas Prácticas para Laboratorios de Control de Calidad Farmacéutica. La decisión se dio tras una exhaustiva inspección realizada por la OMS en noviembre de 2024 y fue anunciada oficialmente el 12 de mayo de 2025.
La certificación, conocida como Precalificación, permite que este laboratorio colombiano siga integrado en la red de laboratorios oficiales de control de medicamentos (LOCM) reconocidos por la OMS. Además, lo habilita como laboratorio de referencia para agencias del sistema de Naciones Unidas que requieran análisis técnicos confiables en el marco de compras y políticas sanitarias globales.
“Esta certificación es un logro para el país que, además, contribuye a la eficacia en la inspección, vigilancia y control que ejerce el Invima como autoridad sanitaria nacional”, afirmó Amelia Velasco, jefe de la Oficina de Laboratorios y Control de Calidad del Invima.
Reconocimiento internacional y cooperación técnica
El estatus de Precalificación implica el reconocimiento mutuo de resultados entre laboratorios internacionales, lo que significa que los análisis realizados por el laboratorio fisicoquímico del Invima tendrán validez en los países autorizados por la OMS. Esta interoperabilidad técnica es esencial para agilizar procesos regulatorios, fortalecer la vigilancia sanitaria y garantizar la calidad de los productos farmacéuticos que ingresan o se producen en Colombia.
La OMS reconoce solo a un grupo limitado de laboratorios en el mundo con este nivel de cumplimiento técnico. En la región, solo Brasil, México, Perú, Uruguay y ahora Colombia cuentan con laboratorios precalificados. Esta distinción posiciona al país como un actor clave en la evaluación y control de medicamentos utilizados, especialmente, en contextos de alta vulnerabilidad o en el tratamiento de enfermedades prioritarias.
Alta exigencia técnica y mejora continua
La renovación de la certificación exige una auditoría rigurosa sobre múltiples dimensiones operativas del laboratorio. Según explicó la doctora Velasco, para mantener este estatus el Invima ha garantizado el cumplimiento permanente de exigencias en estructura, organización, condiciones analíticas, equipamiento, recursos humanos, sistemas de calidad, seguridad industrial, documentos y registros.
Este modelo de mejora continua ha sido fundamental para que Colombia pueda ofrecer garantías internacionales sobre la seguridad y eficacia de los Productos Farmacéuticos Terminados (PFT), tanto de fabricación nacional como importados.
“El laboratorio ha mantenido y se encuentra en un trabajo continuo, garantizando el cumplimiento de los requisitos exigidos por los organismos internacionales”, recalcó la doctora Velasco.
Funciones críticas para la salud pública
La recertificación tiene profundas implicaciones para la salud pública. El laboratorio fisicoquímico del Invima realiza análisis fisicoquímicos de una amplia gama de productos: medicamentos, cosméticos, suplementos dietarios, productos biológicos, fitoterapéuticos y artículos de aseo e higiene doméstica. Estos estudios no solo garantizan que los productos cumplan con los estándares técnicos, sino que también permiten detectar irregularidades o fallos que puedan representar riesgos para la población.
En caso de que se identifiquen incumplimientos, el laboratorio tiene la responsabilidad de alertar a organismos reguladores, compradores y fabricantes, quienes deben tomar medidas correctivas inmediatas. Esta función es especialmente relevante cuando los medicamentos o insumos están destinados al tratamiento de enfermedades potencialmente mortales, como el VIH, la tuberculosis, enfermedades huérfanas o patologías oncológicas, o cuando se trata de productos críticos para la salud materno-infantil y la atención de poblaciones vulnerables.
“Los servicios ofertados por este tipo de laboratorios pueden utilizarse con confianza”, destacó la funcionaria, haciendo énfasis en el impacto que esta recertificación tiene sobre la credibilidad del país en materia de salud pública internacional.
Colombia fortalece su rol regional
La inclusión continua del laboratorio del Invima en la lista de Precalificados por la OMS contribuye al posicionamiento de Colombia como referente técnico y regulatorio en América Latina. En un contexto en el que la vigilancia sanitaria es estratégica para garantizar la calidad de los productos de salud, la recertificación representa no solo un logro institucional, sino un avance estructural para el sistema regulatorio del país.
En particular, esta recertificación refuerza la capacidad del Estado para proteger la salud pública, prevenir riesgos asociados al uso de productos falsificados o de baja calidad, y fortalecer la red de confianza entre autoridades sanitarias, comunidad médica, industria y ciudadanía.
En lo local, esta certificación potencia la eficacia en la inspección, vigilancia y control que realiza el Invima en todo el territorio nacional. Con su alcance nacional, los resultados del laboratorio permiten tomar decisiones regulatorias ágiles frente a alertas sanitarias, cambios normativos y recomendaciones clínicas. Además, fortalece el papel del Invima como ente técnico-científico en un entorno de transformación sanitaria tanto en Colombia como en la región.
La recertificación por parte de la OMS, además de validar los altos estándares del laboratorio, reconoce la capacidad institucional del país para sostener procesos de calidad, transparencia y trazabilidad que se alinean con las mejores prácticas internacionales.
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