Lista de verificación NOM-059 Cofepris
by AUDITORÍA BRUDIFARMA, from the Community
Esta lista de verificación evalúa el cumplimiento de clientes de distribución de medicamentos e insumos para la salud conforme a NOM-059 y criterios de Cofepris. Cubre control documental (avisos, FEUM, RFC), sistema de gestión de calidad, PNO y buenas prácticas de documentación; instalaciones y equipos con condiciones sanitarias; competencias del personal y responsabilidades del responsable sanitario; almacenamiento y transporte con control de temperatura y humedad, PEPS/PCPS y limpieza; validación de sistemas computacionales; y procedimientos para destrucción de insumos caducos. Su objetivo es asegurar la integridad del producto, la trazabilidad en la cadena de suministro y prevenir falsificaciones o adulteraciones.
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