Author： Blackburn Timothy
Publisher： Springer Publishing Company
ISSN： 1872-5120
Source： Journal of Pharmaceutical Innovation, Vol.6, Iss.2, 2011-06, pp. : 69-76
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Abstract
Pharmaceutical development and manufacturing systems typically rely on a Quality by Testing (QbT) model that use release testing and other measures to ensure product quality. However, there is a significant gap between typical pharmaceutical production system capability and supplied quality. To sustain high levels of product supply quality, the industry incurs a high cost of quality and retains value at risk. This paper presents research results from a systems engineering perspective using case study data that quantitatively evaluates the gap between pharmaceutical production system sigma and supplied quality. It also identifies the extent to which emerging Quality by Design (QbD) eliminates system contradictions that prohibit higher production system sigma performance.
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