A suggested developed model for quality losses estimation


Abstract in English

The quality of products in general is of great importance in the current time, and its impact on various aspects of life, such as economy, health and welfare of society as a whole is crucial and visible. It is vital to have a deep understanding of the product realization process, including understanding the dynamics under which the product quality changes under the manufacturing conditions and the customer’s (sensitivity) ability to recognize changes in product quality. This article aims to develop and modify the Taguchi model to suit the case of pharmaceutical products. The model of pharmaceutical quality loss suggested in this paper can be considered as a combination of the traditional concept of quality model and the Taguchi model, modified to suit the case of the pharmaceutical quality. The suggested quality model can be used to assess quantitatively the quality loss value that is associated with each deviation from the established tolerance zone; and accordingly to enhance the understanding of the pharmaceutical manufacturing process to avoid and prevent the occurrence of such loses of the pharmaceutical quality in the future.

References used

X. Y. Lawrence (2008). Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical research, 25 (4), 781-791.
T. Lofthouse (1999). The Taguchi loss function. Work Study, 48 (6), 218-223.
M. M. A. Potdar (2006). Pharmaceutical quality assurance. Pragati Books Pvt. Ltd.
A. Rostami-Hodjegan, P. R. Jackson, G. T. Tucker (1994). Sensitivity of indirect metrics for assessing «rate» in bioequivalence studies — moving the «goalposts» or changing the «game»//Journal of pharmaceutical sciences, 83 (11), 1554-1557.
R. K. Roy (2010). A primer on the Taguchi method. Society of Manufacturing Engineers.
G. Taguchi (1986). Introduction to quality engineering: designing quality into products and processes (No. 658.562 T3).
J. F. Van Leeuwen, M. J. Nauta, D. De Kaste, Y. M. Odekerken- Rombouts, M. T. Oldenhof, M. J. Vredenbregt, D. M. Barends (2009). Risk analysis by FMEA as an element of analytical validation//Journal of pharmaceutical and biomedical analysis, 50 (5), 1085-1087.
L. X. Yu, A. Raw, R. Lionberger, R. Rajagopalan, L. M. Lee, F. Holcombe, R. Adams (2007). US FDA question-based review for generic drugs: A new pharmaceutical quality assessment system// Journal of Generic Medicines, 4 (4), 239-246.

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