Abstract
Research and development of new pharmaceutical products are very knowledge-intensive activities, which require an efficient quality assurance process. The trade-off between quality and time to market is increasingly critical, which generates stress in the face of the risks associated with delays in quality assurance or even longer delays if the regulatory agency rejects the proposal. To help resolve this dilemma in a company involved in the research, production and marketing of biopharmaceuticals, we assessed the knowledge intensity required for quality assurance. This was achieved by breaking down the quality assurance process into tasks and evaluating each of these tasks according to the dimensions of required qualification, autonomy, innovation, information intensity, interdependencies and decision variability. The most demanding dimensions founded in the study were information intensity and innovation, while level of autonomy was low. A content analysis technique was incorporated to uncover the knowledge present in the many documents of past technical reviews. This revealed the main sources of delays in past quality assurance processes and support findings proactive decisions. The working system was redesigned to facilitate the harmonisation of criteria and the presentation of the scientific basis of the results, thereby strengthening interdependencies, information analysis, innovation capacity and qualification.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
Qureshi, Z.P., Seoane‐Vazquez, E., Rodriguez‐Monguio, R., Stevenson, K.B., Szeinbach, S.L.: Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoe R. Pidemiol. Drug Saf. 20(7), 772–777 (2011). https://doi.org/10.1002/pds.2155
Siramshetty, V.B., Nickel, J., Omieczynski, C., Gohlke, B.O., Drwal, M.N., Preissner, R.: WITHDRAWN––a resource for withdrawn and discontinued drugs. Nucleic Acids Res. 44 (2016). https://doi.org/10.1093/nar/gkv1192
Nagaich, U., Sadhna, D.: Drug recall: an incubus for pharmaceutical companies and most serious drug recall of history. Int. J. Pharm. Investig. 5(1), 13–19 (2015)
Suja, C., Manoj, N., Shuhaib, B., Rishana, K.V., Nidina, P., Ashfaque, M.: A Review on drug disaster in the history of medicine. Res. J. Pharm. Technol. 8(4), 481 (2015). https://doi.org/10.5958/0974-360X.2015.00080.3
ICH. Q8(R2). Pharmaceutical Development (2009)
Zurdo, J.: Toward a two-tier process-development paradigm: prototype versus commercial biomanufacturing. Pharm. Bioprocess 3(3), 179–183 (2015)
Drucker, P.F.: Knowledge-worker productivity: the biggest challenge. California Manag. Rev. XLI(2), 79–94 (1999)
Ramírez, Y., Steudel, H.J.: Measuring knowledge work: the knowledge work quantification framework. J. Intellect. Capital 9(4), 564–584 (2008). www.emeraldinsight.com/1469-1930.htm
Rodríguez Hernández, A.G., Casares Li, R., Viña Brito, S.: La evaluación de la intensidad de trabajo de conocimiento en la ingeniería industrial. In: Memorias del VII Simposio de Ingeniería Industrial y Afines. La Habana: ISPJAE (2012)
Rodríguez-Hernández, A.G., Casares-Li, R., Viña-Brito, S.J., Rodríguez-Abril, O.: Diseño de ayudas al trabajador del conocimiento. Ingeniería Ind. 36(2) (2015)
Echevarría Molina, C., Hernández Apaulaza, R., Garza Ríos, R.: Statistical analysis in the evaluation of intensity of knowledge work. In: 11th International Workshop on Operations Research, Universidad de La Habana, Havana, 10th–13th March (2015)
Casares-Li, R., Rodríguez-Hernández, A.G., Viña-Brito, S.: Análisis de errores humanos mediante la tecnología TEREH: experiencias en su aplicación. Ingeniería Ind. 37(1) (2016)
Casares-Li, R., Rodríguez-Hernández, A.G., Viña-Brito, S.: Knowledge patterns to support ergonomic treatment of human error: technology TErEH. In: Boring, R.L. (ed.) Advances in Human Error, Reliability, Resilience, and Performance, pp. 88–98. Springer, Switzerland (2019)
Jacobs, R.L.: Knowledge work and human resource development. Hum. Resour. Dev. Rev. 16(2), 176–202 (2017)
Falzon, P.: Ergonomics, knowledge development and the design of enabling environments. In: Proceedings of the Humanizing Work and Work Environment HWWE 2005 Conference, Guwahati, India, 10–12 December, pp. 1–8 (2005)
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 The Author(s), under exclusive license to Springer Nature Switzerland AG
About this paper
Cite this paper
Viña-Brito, S., Rodríguez-Hernández, A.G., Viña-Rodríguez, L., Rodríguez, Y. (2021). Using Knowledge Work Intensity Assessment to Improve the Effectiveness of Quality Assurance in New Drug Development. In: Black, N.L., Neumann, W.P., Noy, I. (eds) Proceedings of the 21st Congress of the International Ergonomics Association (IEA 2021). IEA 2021. Lecture Notes in Networks and Systems, vol 221. Springer, Cham. https://doi.org/10.1007/978-3-030-74608-7_13
Download citation
DOI: https://doi.org/10.1007/978-3-030-74608-7_13
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-74607-0
Online ISBN: 978-3-030-74608-7
eBook Packages: EngineeringEngineering (R0)