Total Quality Management in the biopharmaceutical industry: "Planning and development of Quality Function Deployment (QFD) for the research and development of products and processes of human plasma derived products”

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Sergio Alejandro Oviedo Albarracin


In the industrial sector, the work of the research and development departments is related both to the processes performed and to the products to be marketed, and it includes everything from the design and development of a new product to the redesign or development of the process of production. Therefore, response time represents a key point in the structure of the company, provided that the response is fast and effective. Besides, the quality of the development and design is not limited to the benefits of the product. Quality Function Deployment (QFD) for Pharmaceutical Products Research and Development appears as an important tool that allows us to face the design or modification of a product or process according to customers needs, and to their expectations about the product quality requirements. In this work we deal with the development of a plasma derived product, on the basis of QFD rules. The application of QFD fulfilled the proposed objectives. QFD added simplicity and reliability to the production as well security and highly competitive costs to both, the product development and the final product itself. QFD was supplemented with Good Manufacturing Practices (GMP), and it also proved to be highly applicable in the pharmaceutical industry even in the case that certification for a quality system is not pursued.


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Author Biography

Sergio Alejandro Oviedo Albarracin, Facultad de Ciencias Químicas - Universidad Católica de Córdoba. Laboratorio de Hemoderivados-Universidad Nacional de Córdoba

Sergio A. Oviedo es profesor de Gestión del Laboratorio y de Gestión de la Calidad en la Universidad Católica de Córdoba (UCC), donde realizó estudios de Doctorado. Es Licenciado en Bioquímica de la Universidad Nacional de Córdoba (UNC) y realizó estudios de Post Grado en la Universidad Tecnológica Nacional obteniendo el Máster en Ingeniería de la Calidad y la Especialidad en Calidad. Es especialista en Gestión de la Calidad del Laboratorio Bioquímico Clínico certificado por el Ministerio de Salud de la Provincia de Córdoba Argentina. Ha participado en trabajos de investigación relacionados con la físico química de proteínas en el Departamento de Físico Química de la Facultad de Ciencias Químicas de la UNC y ha trabajado en el desarrollo de proyectos de investigación en purificación de proteínas de interés farmacéutico y en el desarrollo y escalado productivo de productos farmacéuticos biológicos como IgG anti-D, IgG anti-Hepatitis B, Antitrombina III, Factor VIII. Se ha desempeñado como investigador del área de Investigación y Desarrollo y como Gerente de Garantía de Calidad en el Laboratorio de Hemoderivados de la UNC. Ha participado como docente y expositor en diversos foros internacionales y como director de tesis en proyectos relacionados a la temática de la calidad y los procesos industriales. Se ha desempeñado como Director de Calidad Alimentaria del Gobierno de la Ciudad de Córdoba Argentina y en la Actualidad se desempeña como Sub Director de Farmacia a cargo de la Producción Pública Municipal de Medicamentos y como Director de Grupo de Investigación en Calidad y Asuntos Regulatorios de la Facultad de Ciencias Químicas de la UCC. Acytualmente además de la tarea Docente y de Investigación, se desempeña como Director de Planificación Estratégica del Laboratorio de Hemoderivados de la UNC. 


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