Abstract
We present a framework for the development of design and control spaces that simultaneously considers the raw material property space (Z), the critical to quality process variable space (X), and the critical quality attribute space (Y). The importance of jointly defining all of these spaces and simultaneously considering the eventual process feedforward–feedback control system is illustrated. It is shown that changes in any one of these spaces or in the control system will greatly affect the other spaces. Justification is provided for the use of multivariate principal component analysis and projection to latent structures methods to define more meaningful raw material design spaces and the use of statistical process control concepts to redefine control spaces.
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This article provides a conceptual framework for the development and implementation of design and control spaces in support of the quality-by-design initiative.
Appendix
Appendix
This appendix provides details of the simulation model necessary for the reader to reproduce the results presented in this article. The true simulation model takes the form:
The specific parameter values in Eq. 1 are listed in Table 1.
Furthermore, the specific principal property values for the raw materials (z 1, z 2) that were used in the case study are listed in Table 2.
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MacGregor, J.F., Bruwer, MJ. A Framework for the Development of Design and Control Spaces. J Pharm Innov 3, 15–22 (2008). https://doi.org/10.1007/s12247-008-9023-5
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DOI: https://doi.org/10.1007/s12247-008-9023-5