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”
Main Article Content
صندلی اداریAbstract
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.
Downloads
Article Details
1. Proposal of Policy for Free Access Periodics
Authors whom publish in this magazine should agree to the following terms:
a. Authors should keep the copyrights and grant to the magazine the right of the first publication, with the work simultaneously permitted under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 that allows the sharing of the work with recognition of the authorship of the work and initial publication in this magazine.
b. Authors should have authorization for assuming additional contracts separately, for non-exclusive distribution of the version of the work published in this magazine (e.g.: to publish in an institutional repository or as book chapter), with recognition of authorship and initial publication in this magazine.
c. Authors should have permission and should be stimulated to publish and to distribute its work online (e.g.: in institutional repositories or its personal page) to any point before or during the publishing process, since this can generate productive alterations, as well as increasing the impact and the citation of the published work (See The Effect of Free Access).
Proposal of Policy for Periodic that offer Postponed Free Access
Authors whom publish in this magazine should agree to the following terms:
a. Authors should keep the copyrights and grant to the magazine the right of the first publication, with the work simultaneously permitted under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 [SPECIFY TIME HERE] after the publication, allowing the sharing of the work with recognition of the authorship of the work and initial publication in this magazine.
b. Authors should have authorization for assuming additional contracts separately, for non-exclusive distribution of the version of the work published in this magazine (e.g.: to publish in institutional repository or as book chapter), with recognition of authorship and initial publication in this magazine.
c. Authors should have permission and should be stimulated to publish and to distribute its work online (e.g.: in institutional repositories or its personal page) to any point before or during the publishing process, since this can generate productive alterations, as well as increasing the impact and the citation of the published work (See The Effect of Free Access).
d. They allow some kind of open dissemination. Authors can disseminate their articles in open access, but with specific conditions imposed by the editor that are related to:
Version of the article that can be deposited in the repository:
Pre-print: before being reviewed by pairs.
Post-print: once reviewed by pairs, which can be:
The version of the author that has been accepted for publication.
The editor's version, that is, the article published in the magazine.
At which point the article can be made accessible in an open manner: before it is published in the magazine, immediately afterwards or if a period of seizure is required, which can range from six months to several years.
Where to leave open: on the author's personal web page, only departmental websites, the repository of the institution, the file of the research funding agency, among others.
References
AKAO Y. (1972) New Product Development and Quality Assurance - Quality Deployment System. (Japanese) Standardization and Quality Control, v. 25, n. 4, p. 4-14.
AKAO, Y. (1990) Quality Function Deployment, Productivity Press, Cambridge MA.
ALLEN D. (1994) Desarrollo con Éxito de Nuevos Productos. Ediciones Folio. Barcelona, España.
BATES, D. J.; POPE, D. G.; VICKORY, H. A.; SHLAGER, M. H. (1988) The Role of Research and Development in Pharmaceutical Production. Pharmaceutical Technology, December. p. 38.
BECKELL, T. (1989) Design, Product Planning and Prosperity. Management of Design (Seminar). London Business School.
CHENG, L. C.; DE MELO FILHO, L. D. R. (2010) Platform conceptual model in QFD for generic drug. Product: Management & Development. Brazilian Journal of Product: Management & Development, v. 8, n. 1, p. 3-16.
CLARCK; FUJIMOTO (1991) Product Development Performance. Harvard Business School Press.
COHEN, L. (1995) Quality function deployment: how to make QFD work for you. Addison-Wesley Reaing, Mass, Wokingham, USA
COHN, E. J. et al. (1946) Preparation and properties of serum and plasma protein IV. A system for the separation into fractions of the proteins and lipoprotein components of biological tissue and fluids. J. AM. Chem. Soc., v. 68, p. 459-475.
CURLING, J. M. (1983) Current Practice and future possibilities in plasma protein fractionation. In: CURLING, J. M. (ed): Separation of Plasma Proteins Uppsala: Pharmacia Fine Chemicals AB, p. 5-33.
DISPOSICIÓN ANMAT Nº 2819/2004 (con las modificaciones de la Disp. ANMAT Nº 4844/2005). Lineamientos generales de Buenas Prácticas de Fabricación para Elaboradores, Importadores/Exportadores de Medicamentos.
FARMACOPEA NACIONAL ARGENTINA (2003) 7° Edición. Ministerio de Salud de la Nación Editorial Codex. Avaliable: http://www.anmat.gov.ar/webanmat/fna/fna.asp
FERRÉ, M. R. (1990) El Departamento de I + D; Organización y Control. Ed. Marcombo. Barcelona.
GORIYA, P. D. (2016) Quality Function Deployment – A new approach for traditional medicines to effective product and process development of Guduchi Satva. Dept. of Rasa Shastra & Bhaishajya Kalpana including Drug Research Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University, Jamnagar. 1 st to 3rd July 2016. http://www.gacollege.in/pptns16/pankaj%20goriya.pdf
GORSKY, I.; NIELSEN, R. K. (1992) Scale-Up Used in Liquid Pharmaceutical Manufacturing. Pharmaceutical Technology. September 1992.p.112.
GRAHAM, R. J.; ENGLUND, R. L. (1999) Administración de Proyectos Exitosos. PRENTICE HALL. México.
LOWE, A. J.; RIDGWAY, K. (2001) Quality Function Deployment, University of Sheffield, Avaliable: http://www.shef.ac.uk/~ibberson/qfd.html. Access: 10/03/2017
MIZUNO, S.; YOJI, A. (1994) QFD: The Customer - Driven Approach to Quality Planning and Deployment. Asian Productivity Organization. Ed. JUSE Press, Japan.
MOSES, L.; SINGGIH, D. L.; TRENGGONOWATI, P. D.; KARNINGSIH (2013) Four Phases Quality Function Deployment (QFD) by Considering Kano Concept, Time and Manufacturing Cost. 2° International Conference on Engineering and Technology Development (ICETD 2013). Universitas Bandar Lampung Faculty of Engineering and Faculty of Computer Science. ISSN 2301-6590. Avaliable: https://media.neliti.com/media/publications/170769-EN-four-phases-quality-function-deployment.pdf. Access: 05/06/2017
NICHOLS, N. A (1994) Scientific Management at Merck: An Interview CFO Judy Lewent. Harvard Business Review, p. 59-100.
NORMA IRAM-ISO 9000:2000. Sistemas de Gestión de Calidad - Modelo para el Aseguramiento de la Calidad. Fundamentos y Vocabulario.
NORMA IRAM-ISO 9001:2000. Sistemas de Gestión de Calidad - Requisitos.
OMS, (1994) Informes Técnicos para Producto Biológicos. Comité de Expertos de la OMS en Patrones Biológicos”. Serie 840, Nº 43 Ginebra.
PRAMOD, K. et al. (2016) Pharmaceutical Product Development: A Quality by Design Approach. International Journal of Pharmaceutical Investigation, v. 6, n. 3, p. 129–138.
REAL FARMACOPEA ESPAÑOLA, 5º Edición, BOE de 21/1/2015.
RICO R. R. (1996) Total Customer Satisfaction. Ediciones Macchi. Buenos Aires, Argentina.
RICO, R. R. (1995) Calidad Estratégica Total: Total Quality Management. Ed. Macchi. Bs. As.
SOWREY T. (1989) The Generation of Ideas for News Products. Kogan Page Ltd.
SPERY, R. J.; NASLUND, M.; BAUM, N. (1999) The Principles of Economic Analysis. Cost & Quality, v. 5, n. 1.
STEFAN SCHURR, S.; ARCIDIACONO, G. (2011) Using QFD in Pharmaceutical Quality By Design. 17th International QFD Symposium, ISQFD 2011 - Stuttgart 1 © 2011 QFD Institut Deutschland e.V. © ICQFD © Avaliable: http://old.qfd-id.de/isqfd2011/Sessions/Abstract_Schurr2.pdf© 2011 QFD Institut Deutschland e.V. © ICQFD © Stefan Schurr, Gabriele Arcidiacono
SULLIVAN, L. P. (1986) Quality Function Deployment: A system to assure that customer needs drive the product design and production process. Quality Progress. June. p. 39-50.
TINGSTAD, J. E. (1990) A Profile of Excellence in Technical Manager. Pharmaceutical Technology, September. p. 36.
TINGSTAD, J. E. (1994) Organizational Issues in Pharmaceutical Product R&D in Technical Manager. Pharmaceutical Technology, April. p. 32.
TRHOM S. (1996) ISO 9000 and the Pharmaceutical Industry: The VFA Perspective. Pharmaceutical Technology. August. p. 38.
VONDEREMBSE, M. A.; RAGHUNATHAN, T. S. (1997) Quality function deployment’s impact on product development, International Journal of Quality Science, v. , n. 4, p. 253-271, Avaliable: https://doi.org/10.1108/13598539710192610
YACUZZI, E.; MARTÍN, F. (2003) QFD: Conceptos, Aplicaciones y Nuevos Desarrollos. Serie Documentos de Trabajo - UCEMA.