Rediseño del proceso de trazabilidad para laboratorios farmacéuticos en la ciudad de Bogotá, para sincronizar la herramienta “Traza” del INVIMA con el sistema de información del laboratorio, con el propósito de salvaguardar la vida de los consumidores mediante la implementación del GS1128 en el proceso de la logística de la última milla.

Abstract

The main objective of the document is to propose the redesign of the traceability process in the supply chain in the pharmaceutical laboratories of Bogotá, to carry out the redesign of the process it was initiated with the investigation of the findings found in the quality audits of INVIMA Org. It was carried out, where it was evidenced in that traceability was the item that generated the greatest disagreements in certifications and recertifications. With this information, it is possible to redesign the process based on the current INVIMA regulations and the guidelines of the Lean Logistic theory in the supply chain, the available technologies for the traceability and coding of drugs were evaluated, identifying the most appropriate coding by GS1128 bars adapted to the traceability tool established by the regulatory body. Subsequently, the proposed operation flowcharts were determined and designed in the four main distribution channels: the Manufacturing laboratories, distributors, points of sale, and institutional channels where the proposal is made for the integration of the information provided by each of the participants to the traceability application "Traza of INVIMA". Finally, the analysis of the benefits of generating the integration of information in all stages of the supply chain was carried out, concluding the importance of robust traceability, complying with current regulations, generating greater compliance, improving the internal manufacturing and storage process and distribution to secure the health and preserve the lives of consumers.