Sistematización de controles críticos para la reducción de costos de no calidad en el proceso productivo de blisteado en una empresa farmacéutica / Systematization of critical controls for the reduction of non-quality costs in the blister packaging production process in a pharmaceutical company

Abstract

This undergraduate thesis project proposes the systematization of critical controls in the blistering process of an organization in the pharmaceutical sector, with the primary objective of mitigating the costs of poor quality associated with rework, material waste, and finished product returns. Currently, the management of these controls is manual and fragmented, which limits the proactive detection of deviations and puts strict compliance with Good Manufacturing Practices (GMP) at risk. The research is based on a mixed-methods approach, integrating advanced methodologies such as the PDCA cycle, the HACCP system, and Lean Six Sigma principles. As a result, a standardized documentary system is designed to optimize operational traceability and ensure the reliability of evidence for regulatory authorities.