Propuesta de implementación de un modelo de gestión de procesos para la mejora en la productividad mediante el diseño de un sistema de planificación y control de la producción en el área de sólidos no estériles en una industria farmacéutica

Abstract

This paper proposes implementing a process management model to improve productivity in the manufacturing of 850 mg Metformin tablets in the non-sterile area of a pharmaceutical company. Currently, the planning system operates directly based on orders or contracts, and the tablet manufacturing process follows procedures outlined in production records, which specify the control parameters and quality attributes that must be complied at each phase of the process. A mixed methods methodology was used for this study, which included an analysis of production capacities, assessments of the operating environment, evaluations of implemented improvements, and simulations using specialized software (FlexSim). Actual production times were identified, facilitating the redesign of key processes such as raw material transport and granulate drying. Continuous improvement opportunities were established within the production process, including replacing the drying oven and reconfiguring the layout. These changes led to a 32% reduction in material handling distance, a 22% decrease in material transport time, and an 84% reduction in energy costs. As a result, monthly productivity increased by 15%, reaching a total of 115,000 tablets per batch and generating an additional USD 900 in monthly revenue per batch. The proposed model is feasible, sustainable, and delivers significant improvements both operationally and financially.