Aspects to consider for the introduction of a new manufacturing process in a multiproduct certified plant
Abstract
In this study, a risk identification method is applied for introducing a new manufacturing process using Saccharomyces cerevisiae as host cell, in a certified multiproduct plant, where intermediate products are manufactured using Escherichia coli, in addition risk control actions are proposed. The quality risk analysis was applied, with the support of basic tools and techniques as observation, teamwork, brainstorming and 6M analysis. As a result, the risks associated to the process, to the facility and to the changeover were identified. All risk control actions were implemented with the same priority during the introduction of this new process as part of Good Manufacturing Practices compliance.References
Pearson S. Multiproduct Manufacturing Facilities. Genetic Engineering and Biotechnology 2006;26(6). Disponible en: http://www.genengnews.com/gen-articles/multiproduct -manufacturing-facilities/1447/
Dutton G. Designing & Running Multiproduct Facilities. Genetic Engineeing and biotechnology 2007;27(6). Disponible en: http://www.genengnews.com/gen-articles/designing-running -multiproduct-facilities/2066/
Milá L, Valdés R, García C, Tamayo A, Padilla S, Ortega M. Quality risk Management Application review in Pharmaceutical and Biopharmaceutical industries. Bioprocessing Journal 2010;9(1):25-34.
Agencia Europea de Medicamentos. Conferencia Internacional de Armonización de Requisitos Técnicos para el Registro de Medicamentos para Uso Humano. Guía ICH Q9 Gestión de riesgos. London: EMEA; 2006.
Martines J. Introducción al análisis de riesgos. México, DF: Editorial LIMUSA; 2007.
ISO 14971. Medical devices-Application of risk management to medical devices. Boston: ISO; 2007.
European Medicinal Evaluation Agency. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 20 Quality Risk Management. London: EMEA; 2008.
European Medicines Agency. Quality Risk Management (ICH Q9). London: EMA/INS/GMP/79766; 2011.
Guerra I. Evaluación y mejora continua: Conceptos y herramientas para la medición y mejora del desempeño. Bloomington, Indiana: Editorial AuthorHouse; 2007.
Malevski Y, Rozotto A. Manual de gestión de la calidad total a la medida. Guatemala: Editorial Piedra Santa; 1995.
Cruz Lezama O. Indicadores de Gestión; 2009. Disponible en: http://www.monografias.com/trabajos55/indicadores-de -gestion/indicadores-de-gestion3.shtml.
Rey F. Técnicas de resolución de problemas. Madrid: Editorial Fundación Confemetal; 2003.
Mateu J, Sirvent R y Sagasta S. Manual de Control Estadístico de Calidad: Teoría y aplicaciones. Castellón de la Plana: Universitat Jaume I; 2006.
Sánchez E, Palomino A, Rivero J. Manual para la Integración de sistemas de gestión. Madrid: Editorial Fundación Confemetal; 2006.
Organización Mundial de la Salud (OMS), Serie de informes técnicos. No. 822. Anexo 1, Buenas Prácticas Farmacéuticas en Productos Biológicos. Ginebra: OMS; 1992.
Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED), Anexo No. 09: Buenas Prácticas para la Fabricación de Ingrediente Farmacéuticos Activos de la Regulación No. 16-2006. Directrices sobre Buenas Prácticas para la fabricación de Productos Farmacéuticos. La Habana: CECMED; 2006.
World Health Organization (WHO). No. 908. Technical Report Series. Annex 4, Good Manufacturing Practices for pharmaceutical products: main principles. Geneva: WHO; 2003
WHO/IVB/05.24. A WHO guide to good manufacturing practice (GMP) requirements, Part 3 training. Geneva: WHO; 2006.
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