La calidad desde el diseño: principios y oportunidades para la industria farmacéutica
DOI:
https://doi.org/10.1016/j.estger.2014.09.005Palabras clave:
Calidad desde el diseño, Industria farmacéutica, Gestión de la calidadResumen
La calidad desde el diseño ofrece ventajas sobre modelos previos de aseguramiento de la calidad, siendo útil en sectores donde la calidad signifique diferenciación y la flexibilización de los procesos estimule el mejoramiento continuo y la innovación. Como una contribución para facilitar su implementación en la industria farmacéutica en Colombia, en el presente artículo se analizan las circunstancias que la originaron. Igualmente, partiendo de un estudio de literatura especializada, se explica su importancia en el desarrollo de productos y se proponen algunos aspectos metodológicos para su puesta en práctica. La evidencia reportada sugiere que esta nueva visión de la calidad es una estrategia que genera confianza en clientes, industria y organismos reguladores, respecto a la calidad de los productos farmacéuticos.
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Adam, S., Suzzi, D., Radeke, C. y Khinast, J. (2011). An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation. European Journal of Pharmaceutical Science, 42(1–2), 106–115.
Al-Hakim, L. y Jin, C. (2014). Quality innovation: Knowledge, theory, and practices. Hershey, PA: IGI Global.
Alavi, M. y Leidner, D. (2001). Review: Knowledge management and knowledge management systems: Conceptual foundations and research issues. MIS Quarterly, 25(1), 107–133.
Andreasen, B., Blasi, J., Fabritz, H., Feldthusen, H., Guldager, N. y Moelgaard, G. (2011). Risk-MaPP, ICH Q9, ASTM 2500 in action: project advantages of practical quality risk management approaches. Pharmaceutical engineering, 31(1), 36–43.
ANDI (2014). Presentación cifras de la industria a Mayo de 2014. Cámara de la industria farmacéutica. [consultado 31 Ago 2014]. Disponible en: http://es.scribd.com/doc/202399419/3-Panorama-Actual-de-la-Industria-Farmaceutica-2011-20120321-021943
Ansari, F., Khobreh, M., Nasiri, S. y Fathi, M. (2009). Knowledge Management Support for Quality Management to Achieve Higher Customer Satisfaction. Proceedings of the 2009 IEEE International Conference on Electro/Information Technology, IEEE EIT 2009, Windsor, Ontario, Canada, Junio 7-9, 2009. IEEE Press, 78-83.
Arcila, R. (2011). De dónde venimos y para dónde vamos en el mercado farmacéutico en Colombia: retos en el corto y largo plazo. Presentación del Director Ejecutivo de la cámara farmacéutica de la ANDI. ANDI. [consultado 31 Ago 2014]. Disponible en: http://www anif.co/sites/default/files/uploads/Rodrigo%20Arcila%20-%20Andi.pptx.
ASTM (2008). ASTM E2537 - Standard guide for application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing. West Conshohocken, PA: ASTM International. doi:10.1520/E2537-08.
Bos, T., Irving, P. y Rees, P. (2010). Risk-based MES implementation using Hazard. Analysis and critical control points (HACCP). Pharmaceutical engineering, 30(6), 8–22.
Brindle, A., Davy, S., Tiffany, D. y Watts, C. (2012). Risk Analysis and Mitigation Matrix (RAMM) – A risk tool for quality management. Pharmaceutical engineering, 32(1), 26–35.
Campbell, I. y Thibeault, D. (2012). A quality risk management approach to review and monitor cleaning processes. Pharmaceutical engineering, 32(1), 48–55.
Caraballo, I. (2009). Critical points in the formulation of pharmaceutical swellable controlled release dosage forms Influence of particle size. Particuology, 7(6), 421–425.
Chandy, R. y Tellis, G. (1998). Organizing for radical product innovation: The overlooked role of willingness to cannibalize. Journal of Marketing Research, 35(4), 474–487.
Charoo, N., Shamsher, A., Zidan, A. y Rahman, Z. (2012). Quality by design approach for formulation development: a case study of dispersible tablets. International Journal of Pharmaceutics, 423(2), 167–178.
Davis, B., Lundsberg, L. y Cook, G. (2008). PQLI Control strategy model and concepts. Journal of Pharmaceutical Innovation, 3(2), 95–104.
DeFeo, J. (2001). The tip of the Iceberg. Quality Progress, 34(5), 29–37.
Diaz, R., Fernández, G. y Muzzio, C. (2011). Practical application of quality risk management to the filling process of betamethasone injections. Pharmaceutical engineering, 31(4), 84–89.
Departamento de Defensa de los Estados Unidos (1980). Military Standard 1629A. Procedures for performing a failure mode, effects and criticality analysis. Washington D.C. [consultado 11 Sep 2014]. Disponible en: https://src.alionscience.com/pdf/MIL-STD-1629RevA.pdf
Drakulich, A. y Van Arnum, P. (2010). Applying QbD to excipient formulation and development. Pharmaceutical Technology, 34(5), 24–29.
Dubey, A., Boukouvala, F., Keyvan, G., Hsia, R., Saranteas, K., Brone, D., et al. (2012). Improvement of tablet coating uniformity using a quality by design approach. AAPS PharmSciTech, 13(1), 231–246.
Fahmy, R., Kona, R., Dandu, R., Xie, W., Claycamp, G. y Hoag, S. (2012). Quality by design I: Application of failure mode effect analysis (FMEA) and Plackett-Burman design of experiments in the identification of main factors in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tablets. AAPS PharmSciTech, 13(4), 1243–1254.
Feigenbaum, A. (1961). Total quality control. New York, NY: McGraw Hill.
Food and Drug Administration (2002). Pharmaceutical quality for the 21st century: a risk-based approach. Rockville, MD: Department of Health and Human Services - Food and Drug Administration.
Food and Drug Administration (2004). Guidance for industry. PAT–a framework for innovative pharmaceutical development, manufacturing and quality assurance. Rockville, MD: Department of Health and Human Services - Food and Drug Administration.
Food and Drug Administration (2009). Understanding challenges to quality by design. FDA Understanding Challenges to QbD Project [consultado 15 Nov 2014]. Disponible en: http://www.pharmaqbd.com/wp-content/uploads/2011/05/Understanding-Challenges-to-Quality-by-Design.pdf
Gallo, J. (2009). Estudio de la relación proveedor - productor en la gestión de materiales del sector farmacéutico industrial productivo (sfip) de la ciudad de Bogotá. Disertación tesis de Maestría. Bogotá: Universidad Nacional.
Garcia, T., Cook, G. y Nosal, R. (2008). PQLI key topics - criticality, design space, and control strategy. Journal of Pharmaceutical Innovation, 3(2), 60–68.
Guebitz, B., Schnedl, H. y Khinast, J. (2012). A risk management ontology for qualityby- design based on a new development approach according GAMP 5.0. Expert Systems with Applications, 39(2012), 7291–7301.
Hall, G. y Runas, R. (2007). JPI Interviews Moheb Nasr, PhD. Journal of Pharmaceutical Innovation., 2(3–4), 67–70.
Henderson, R. y Clark, K. (1990). Architectural innovation: The reconfiguration of existing product technologies and the failure of established firms. Administrative Science Quarterly, 35(1), 9–22.
Huang, J., Kaul, G., Cai, C., Chatlapalli, R., Hernandez-Abad, P., Ghosh, K., et al. (2009). Quality by design case study: an integrated multivariate approach to drug product and process development. International Journal of Pharmaceutics, 382(1–2), 23–32.
Hulbert, M., Feely, C., Inman, E., Johnson, A., Kearney, A., Michaels, J., et al. (2008). Risk management in the pharmaceutical product development process. Journal of Pharmaceutical Innovation, 3(4), 227–248.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. D (2005). ICH Q9 Quality Risk Management. Geneva, Switzerland.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use.D (2008). ICH Q10 Pharmaceutical Quality System. PL Geneva, Switzerland.
PC International conference on harmonization of technical requirements for registration of pharmaceuticals for human use.D (2009). ICH Q8R2 Pharmaceutical Development. PL Geneva, Switzerland.
ISO 9004 (2000). Quality management systems – Guidelines for performance improvement. 2.a ed, PL Ginebra, Suiza.
ISO 9000 (2005). Quality management systems – fundamentals and vocabulary. EDN 3.a ed. PL Ginebra, Suiza.
ISO 9001 (2008). Quality management systems – Requirements. EDN 4.a ed, Ginebra, Suiza.
Jadhav, M. y Tambe, S. (2013). Implementation of QbD approach to the analytical method development and validation for the estimation of propafenone hydrochloride in tablet dosage form. Chromatography Research International, 2013, 1–9.
Juran, J. (1992). Juran on quality by design: the new steps for planning quality into goods and services. New York: The Free Press.
Kamm, J. (2007). Can you win the space race? Pharmaceutical manufacturing. [consultado 31 Ago 2014]. Disponible en: http://www.pharmamanufacturing.com/issues/2007/005/
Lee, Y., Kim, M., Park, M. y Han, K. (2012). Quality by design: understanding the formulation variables and optimization of metformin hydrochloride 750 mg sustained release tablet by Box Behnken design. Journal of Pharmaceutical Investigation, 42(4), 213–220.
Lepore, J. y Spavins, J. (2008). Product quality lifecycle implementation (PQLI) innovations. PQLI design space. Journal of Pharmaceutical Innovation, 3(2008), 79–87.
Lionberger, R., Lee, S., Lee, L., Raw, A. y Yu, L. (2008). Quality by design: concepts for ANDAs. The AAPS journal, 10(2), 268–276.
Maes, I. y Van Liedekerle, B. (2006). The need for a broader perspective if process analytical technology implementation is to be successful in the pharmaceutical sector. Journal of Pharmaceutical Innovation, 1(1), 19–21.
Martin, E., Montague, G. y Robbins, P. (2013). A quality by design approach to process plant cleaning. Chemical Engineering Research and Design, 91(6), 1095–1105.
McGregor, J. y Bruwer, M. (2008). A framework for the development of design and control spaces. Journal of Pharmaceutical Innovation, 3(1), 15–22.
McCurdy, V., Ende, M., Busch, F., Mustakis, J., Rose, P. y Berry, M. R. (2010). Quality by design using an integrated active pharmaceutical ingredient - drug product approach to development. Pharmaceutical engineering, 30(4), 12–33.
Mhatre, R. y Rathore, A. (2009). Quality by design: an overview of the basic concepts. In Quality by design for biopharmaceuticals (pp. 1–8). Hoboken, NJ: John Wiley & Sons.
Naelapää, K., Veski, P. y Bertelsen, P. (2010). Building quality into a coating process. Pharmaceutical Development and Technology, 15(1), 35–45.
Nasr, M. (2006). Risk-based CMC review and quality assessment: what is Quality by Design (QbD). Conferencia FDA/Industria. Philadelphia, PA: School of pharmacy - Temple University.
Noble, P. (2012). Applying Fault Tree Analysis (FTA) as a top level risk management tool in software development. Pharmaceutical engineering, 32(1), 74–81.
Nonaka, I. (1994). A dynamic theory of organizational knowledge creation. Organization Science, 5(1), 14–37.
Nosal, R. y Schultz, T. (2008). PQLI Definition of criticality. Journal of Pharmaceutical Innovation, 3(2), 69–78.
Organización Mundial de la Salud (1996). WHO Expert committee on Specifications for pharmaceutical Preparations - Reporte 34: Anexo 6. Ginebra, Suiza.
Organización Mundial de la Salud (2012). WHO Expert committee on Specifications for pharmaceutical Preparations – Reporte 46: Anexos 3 y 5. Ginebra, Suiza.
Organización Mundial de la Salud (2013). WHO Expert committee on Specifications for pharmaceutical Preparations – Reporte 47: Anexo 2. Ginebra, Suiza.
Politis, S. y Rekkas, D. (2011). The evolution of the manufacturing science and the pharmaceutical industry. Pharmaceutical research, 28(7), 1779–1781.
Portillo, P., Ierapetritou, M., Tomassone, S., Mc Dade, C., Clancy, D., Avontuur, P., et al. (2008). Quality by design methodology for development and scale-up of batch mixing processes. Journal of Pharmaceutical Innovation, 3(4), 258–270.
Potter, C. y Berridge, J. (2010). PQLI Roadmap: Product design, development, and realization, a science- and risk-based approach to implementation - An overview of ISPEs first PQLI guide. Pharmaceutical engineering, 30(2), 1–6.
Prpich, A., Ende, M., Katzschner, T., Lubczyk, V., Weyhers, H. y Bernhard, G. (2010). Drug product modeling predictions for scale-up of tablet film coating - A quality by design approach. Computers and Chemical Engineering, 34(7), 1092–1097.
Rathore, A. (2009). Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends in biotechnology, 27(9), 546–553.
Rathore, A., Bansal, A. y Jaspinder, H. (2013). Knowledge management and process monitoring of pharmaceutical processes in the quality by design paradigm. Advances in Biochemical Engineering/Biotechnology, 132, 217–247.
Rattan, A. y Rubacha, M. (2014). Applying a consistent, compliant and practical riskbased validation process for laboratory systems. Pharmaceutical engineering, 34(2), 1–7.
Reklaitis, G., Khinast, J. y Muzzio, F. (2010). Pharmaceutical engineering science. New approaches to pharmaceutical development and manufacturing. Chemical Engineering Science, 65(21), 4–7.
Riley, B. y Li, X. (2011). Quality by design and process analytical technology for sterile products -where are we now? AAPS PharmSciTech, 12(1), 114–118.
Ring, D., Oliveira, J. y Crean, A. (2011). Evaluation of the influence of granulation processing parameters on the granule properties and dissolution characteristics of a modified release drug. Advanced Powder Technology, 22(2), 245–252.
Rocha, H., Cuadro, J. y Mora, C. (2013). Aplicación de la calidad basada en el diseño (QbD) en la reformulación de tabletas masticables. Revista Colombiana de Ciencias Químico Farmacéuticas, 42(2), 190–214.
Roy, S. (2012). Quality by design: A holistic concept of building quality in pharmaceuticals. International Journal of Pharmaceutical and Biomedical Research, 3(2), 100–108.
Savic, I., Marinkovic, V., Tasic, L. y Krajnovic, D. (2012). From experimental design to quality by design in pharmaceutical legislation. Accredit Qual Assur, 17(6), 627–633.
Shivhare, M. y Mccreath, G. (2010). Practical Considerations for DoE Implementation in Quality by Design. Bioprocess International [consultado 31 Ago 2014]. Disponible en: http://www.bioprocessintl.com/wp-content/uploads/bpi-content/BPI_A_100806AR03_O_98037a.pdf
Somma, R. (2007). Development knowledge can increase manufacturing capability and facilitate quality by design. Journal of Pharmaceutical Innovation, 2(3–4), 87–92.
Staples, M. (2010). The concept of Quality by design. Pharmaceutical Stability Testing to Support Global Markets (pp. 101–106). New York, NY: Springer.
Torbeck, L. y Branning, R. (2009). QbD: Convincing the Skeptics. BioPharm International, 22(5), 52–58.
Trivedi, B. (2012). Quality by design (qbd) in pharmaceuticals. International Journal of Pharmacy and Pharmaceutical Sciences, 4(1), 17–29.
Troup, G. y Georgakis, C. (2013). Process systems engineering tools in the pharmaceutical industry. Computers & Chemical Engineering, 51, 157–171.
Vallejo, B., Cortés, C., Espinosa, A. y Barbosa, H. (2004). Aplicación de la metodología del diseño axiomático en el desarrollo de productos de liberación modificada. Revista Ingeniería e Investigación, 24(3), 41–48.
Van Leeuwen, J., Nauta, M., de Kaste, D., Odekerken-Rombouts, Y., Oldenhof, M., Vredenbregt, M., et al. (2009). Risk analysis by FMEA as an element of analytical validation. Journal of Pharmaceutical and Biomedical Analysis, 50, 1085–1087.
Verma, S., Lan, Y., Gokhale, R. y Burgess, D. (2009). Quality by design approach to understand the process of nanosuspension preparation. International Journal of Pharmaceutics, 377(1–2), 185–198.
Weinberg, S. (2011). Quality by design, in cost-contained regulatory compliance: For the pharmaceutical, biologics, and medical device industries. Hoboken, NJ: Wiley & Sons.
Woodcock, J. (2005). AAPS Workshop - Pharmaceutical quality assessment - a science and risk-based CMC approach in the 21st century. Pharmaceutical quality in the 21st century - an integrated systems Approach. North Bethesda, MD, Octubre 5 -7, 2005.
Wu, H., Khan, M. y Hussain, A. (2007). Process Control Perspective for Process Analytical Technology: Integration of Chemical Engineering Practice Into Semiconductor and Pharmaceutical Industries. Chemical Engineering Communications, 194(6), 760–779.
Wu, H., Tawakkul, M., White, M. y Khan, M. (2009). Quality-by-Design (QbD): An integrated multivariate approach for the component quantification in powder blends. International Journal of Pharmaceutics, 372(1–2), 39–48.
Xu, X., Khan, M. y Burgess, D. (2011). A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment. International Journal of Pharmaceutics, 419(1–2), 52–59.
Xu, X., Khan, M. y Burgess, D. (2012). A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale. International Journal of Pharmaceutics, 423(2), 543–553.
Yu, L. (2008). Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical research, 25(4), 781–791.
Zhang, L., Yan, B., Gong, X., Yu, L. y Qu, H. (2013). Application of quality by design to the process development of botanical drug products: a case study. AAPS PharmSciTech, 14(1), 277–286.
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