medigraphic.com
ISSN 1561-2988 (Print)

2013, Number 2

<< Back Next >>

Rev Cubana Farm 2013; 47 (2)

Quality risk analysis in a changeover. Stage of cleaning

López GY, Beldarraín IA, Alegret SOE, Álvarez BD, García SCA, Ramos AM, Hernández ML

Language: Spanish
References: 23
Page: 147-156
PDF size: 1209.46 Kb.


ABSTRACT

Objective: to identify the general risks in the cleaning phase during changeover in a multiproduct plant for biological products and to put forward control actions to reduce them, guaranteeing to focus attention on the unacceptable identified risks and their scenarios.
Methods: aquality risk analysis using the tool called Failure Mode and Effect Analysis was made, which allowed identifying pollution-associated risks and their settings, and working proactively according to the results of the risk priority number estimation.
Results: it was proven that the product and the cleaning agent residues may compromise the cleaning phase. Several actions that should be documented in the cleaning procedures of non-dedicated equipment were then suggested.
Conclusions: the general risks as well as their settings were identified. The implemented risk management actions reduced total risk priority number values by over 50 % in order to assure the effectiveness of the changeover operation as part of the compliant requirements for Good Manufacturing Practices.


REFERENCES

  1. Pearson S. Multiproduct Manufacturing Facilities. Genetic Engineering and Biotechnology [Internet]. 2006 [cited 2012 Feb 2];26(6). Available from: http://www.genengnews.com/gen-articles/multiproduct-manufacturingfacilities/ 1447/

  2. Dutton G. Designing & Running Multiproduct Facilities. Genetic Engineeing Biotechnology [Internet]. 2007 cited 2012 Feb 2];27(6). Available from: http://www.genengnews.com/gen-articles/designing-running-multiproductfacilities/ 2066/

  3. Pavlovic D. PLM (Product Lifecycle Management) en la Industria Farmacéutica. Farmaespaña Industrial. 2010 May.-Jun;60.

  4. Milá L, Valdés R, Garcia C, Tamayo A, Padilla S, Ortega M. Quality risk Management Application review in Pharmaceutical and Biopharmaceutical industries. Bioprocessing J. 2010;9(1):25-34.

  5. 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.

  6. Martines J. Introducción al análisis de riesgos. México, DF: Editorial LIMUSA; 2007.

  7. International Organization for Standardization (ISO) 14971. Medical devises- Application of risk management to medical devises. Ginebra: ISO; 2007.

  8. European Medicinal Evaluation Agency. EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use. Annex 20 Quality Risk Management. Brussels: European Commission; 2008.

  9. European Medicinal Agency. Quality Risk Management (ICH Q9). EMA/INS/GMP/79766/2011. London: EMA; 2011.

  10. Guerra I. Evaluación y mejora continua: Conceptos y herramientas para la medición y mejora del desempeño. Bloomington, Indiana: Editorial AuthorHouse; 2007.

  11. Francisco J. Las siete nuevas herramientas para la mejora de la calidad. Madrid: Editorial Fundación Confemetal; 1997.

  12. Malevski Y,Rozotto A. Manual de gestión de la calidad total a la medida. Guatemala: Editorial Piedra Santa; 1995.

  13. Cruz Lezama O. Indicadores de gestión. 2009. [citado 16 Feb 2011]. Disponible en: http://www.monografias.com/trabajos55/indicadores-de-gestion/indicadores-degestion3. shtml

  14. Rey F. Técnicas de resolución de problemas. Madrid: Editorial Fundación Confemetal; 2003. p. 68-80.

  15. Mateu J, Sirvent R, Sagasta S. Manual de control estadístico de calidad: Teoría y aplicaciones. Castellón de la Plana: Universitat Jaume I; 2006.

  16. Francisco M. El Kaizen: la filosofía de mejora continua e innovación incremental detrás de la administración por calidad total. México, DF: Panorama; 2007.

  17. International Organization for Standardization (ISO) 31010. Risk management- Risk assessment techniques. Ginebra: ISO; 2009.

  18. Sánchez E. Manual para la integración de sistemas de gestión. Madrid: Editorial Fundación Confemetal; 2006.

  19. Frey B, Koczan D, Shrout. Implementing a Compliant Cleaning Program in the Dietary Supplement Industry. Contract Pharma. Annual Manufacturing Supplement. 2007;9(2):S18-S19.

  20. Brewer R. Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device, and Diagnostic Industries, in Validation of Pharmaceutical Processes. 3rd ed. Carleton: Informa Healthcare USA, Inc.; 2008. p. 491-519.

  21. Selman E. La producción industrial de inyectables. Un enfoque según las exigencias actuales. La Habana: Editorial CIMEQ; 2001.

  22. Behme S. Manufacturing of pharmaceutical proteins: from technology to economy. New Jersey; John Wiley & Sons; 2009. p. 189-93.

  23. Reyes B, Gasmuri A, Pérez G, Díaz A, Mora Y, Baltrell N. Áreas limpias, control e higienización después de un cambio. Farmaespaña Industrial. 2009 Nov/Dic:2.




2020     |     www.medigraphic.com