Implementación de estrategias de optimización en los procedimientos analíticos de materias primas en el Laboratorio Chile-Teva Pharmaceutical
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Archivos
Fecha
2023
Autores
Profesor/a Guía
Facultad/escuela
Idioma
es
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Universidad Andrés Bello
Nombre de Curso
Licencia CC
Licencia CC
Resumen
En el marco de un mercado farmacéutico nacional dinámico y con presencia de
una multiplicidad de actores, la optimización de procesos desempeña un rol
fundamental aportando a la competitividad de las empresas mediante la
reducción de posibles costos asociados a la elaboración de medicamentos.
Bajo dicho contexto, el propósito del presente seminario de título fue llevar a cabo
la optimización de los procedimientos analíticos aplicados a las materias primas
del laboratorio Chile-Teva, con el objetivo de lograr una reducción efectiva de
costos sin comprometer la calidad, seguridad y eficacia de dichos productos. La
metodología se basó en la mejora de un procedimiento previamente establecido
de calificación de proveedores, desarrollándose un estudio cualitativo
retrospectivo con enfoque en la evaluación documental del cumplimiento de los
parámetros de calidad, tanto por parte del proveedor/fabricante como del
laboratorio de control de calidad de laboratorio Chile-Teva. Se aseguró una
adecuada actualización de la documentación asociada a dichas modificaciones y
se pudo estimar el impacto económico de las estrategias implementadas
mediante un análisis de dos materias primas específicas. Se obtiene como
resultado la certificación para reducción de test de 37 proveedores/fabricantes de
un total de 40 evaluados, se identificaron 174 test críticos y 316 no críticos de un
total de 490. Se concluye finalmente que la estrategia de optimización del análisis
de materias primas ha tenido éxito al incrementar significativamente la eficiencia
del proceso. Mediante el análisis económico se pudo evidenciar que con las
reducciones en la frecuencia de análisis de las materias primas se logra agilizar
tiempos y disminuir el uso de recursos. Económicamente, se aprecia una
reducción de costos tomando como base el análisis del API Gemfibrozilo y el
excipiente crítico Polivinilpirrolidona. Estos logros respaldan el impacto positivo
de este trabajo en la compañía, brindando beneficios tangibles y ofreciendo
perspectivas favorables en la empresa.
In the context of a dynamic national pharmaceutical market with a multitude of stakeholders, process optimization plays a pivotal role in enhancing companies' competitiveness by reducing potential costs associated with pharmaceutical manufacturing. Within this framework, the purpose of this thesis seminar was to conduct the optimization of analytical procedures applied to raw materials at the Chile-Teva laboratory, aiming to achieve effective cost reduction without compromising the quality, safety, and efficacy of these products. The methodology centered on refining a previously established supplier qualification procedure, involving a retrospective qualitative study focusing on documentary assessment of quality parameter compliance, both by suppliers/manufacturers and the Chile-Teva quality control laboratory. Adequate documentation updates were ensured for these modifications, and the economic impact of the implemented strategies was estimated through an analysis of specific raw materials. As a result, certification for test reduction was achieved for 37 out of 40 evaluated suppliers/manufacturers, with 174 critical tests and 316 non-critical tests identified out of a total of 490. In conclusion, the optimization strategy for raw material analysis has been successful in significantly enhancing process efficiency. Reductions in raw material analysis frequency have streamlined time and resources. Procedural modifications ensure data and documentation integrity. Economically, noteworthy cost reduction is observed for the API Gemfibrozil and the critical excipient Polivinylpyrrolidone. These achievements underscore the positive impact of this work within the company, providing tangible quality control benefits in pharmaceutical manufacturing and offering promising prospects in the company.
In the context of a dynamic national pharmaceutical market with a multitude of stakeholders, process optimization plays a pivotal role in enhancing companies' competitiveness by reducing potential costs associated with pharmaceutical manufacturing. Within this framework, the purpose of this thesis seminar was to conduct the optimization of analytical procedures applied to raw materials at the Chile-Teva laboratory, aiming to achieve effective cost reduction without compromising the quality, safety, and efficacy of these products. The methodology centered on refining a previously established supplier qualification procedure, involving a retrospective qualitative study focusing on documentary assessment of quality parameter compliance, both by suppliers/manufacturers and the Chile-Teva quality control laboratory. Adequate documentation updates were ensured for these modifications, and the economic impact of the implemented strategies was estimated through an analysis of specific raw materials. As a result, certification for test reduction was achieved for 37 out of 40 evaluated suppliers/manufacturers, with 174 critical tests and 316 non-critical tests identified out of a total of 490. In conclusion, the optimization strategy for raw material analysis has been successful in significantly enhancing process efficiency. Reductions in raw material analysis frequency have streamlined time and resources. Procedural modifications ensure data and documentation integrity. Economically, noteworthy cost reduction is observed for the API Gemfibrozil and the critical excipient Polivinylpyrrolidone. These achievements underscore the positive impact of this work within the company, providing tangible quality control benefits in pharmaceutical manufacturing and offering promising prospects in the company.
Notas
Seminario (Químico Farmacéutico)
Palabras clave
Industria Farmacéutica, Administración de la Producción