Diseño de un plan de mejoramiento para la implementación de buenas prácticas de manufactura en un laboratorio farmacéutico

Abstract

Adequate compliance with Good Manufacturing Practices (GMP) in a pharmaceutical laboratory is essential to guarantee the quality, safety and efficacy of the drugs produced. This work will focus on analyzing and evaluating the current GMP implementation process in pharmaceutical laboratories and proposing strategies to optimize and strengthen this process. Aspects such as personnel education and training, quality management, process validation, documentation control and adequate infrastructure will be considered. The objective is to design a Good Manufacturing Practices improvement plan for a Pharmaceutical Laboratory, through the selection of technical elements and literature review for the assurance of the quality management of the processes in the elaboration of medicines n order to ensure compliance with regulatory standards and guarantee the production of safe and high quality drugs, innovative practices and state-of-the-art technologies in the implementation of GMP will be explored. At the end, it is expected to provide concrete and substantiated recommendations to improve the efficiency and effectiveness of the GMP manual through an outline to achieve successful implementation, in order to contribute to the progress and success of the pharmaceutical laboratory in achieving its quality and regulatory compliance objectives.