Todos los medicamentos y principios activos fabricados o importados en la Unión Europea, incluidos los medicamentos destinados a la exportación y aquellos destinados a la realización de ensayos clínicos, deben fabricarse de conformidad con los principios y directrices de las normas de correcta fabricación (NCF), son aplicables a los fabricantes de los medicamentos y responsables de su comercialización, fabricantes de principios activos y excipientes y empresas de distribución.

Las NCF de medicamentos y de principios activos, cumplen la legislación de la Unión Europea, estando traducidas y publicadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

Es necesario garantizar el cumplimiento de las directrices establecidas en las NCF, que son auditadas de manera periódica por la AEMPS.

Beneficios

  • Garantiza el cumplimiento de las obligaciones legales en cuanto a la fabricación y/o distribución de medicamentos.
  • Ofrece un marco para el diseño e implantación de sistemas de calidad y seguridad para los fabricantes o empresas que distribuyen medicamentos.
  • Homologaciones y reconocimiento por parte de los fabricantes de medicamentos.
  • Proporcionar herramientas contrastadas de gestión; definición y revisión de procesos, …

Herramientas

  • Análisis de riesgos y control de proceso.
  • Procedimientos normalizados de trabajo.
  • Reingeniería de procesos.

HOMOLOGACIONES

Sectores relacionados

Químico, farma y consméticos

Distribución, transporte y almacenamiento

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