Quality by Design

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Chapter: Pharmaceutical Engineering: Quality by Design

It has long been a principle of scientific discovery that a rational strategy is essential to a clear understanding of phenomena and to the creation of knowledge.


Quality by Design

INTRODUCTION

It has long been a principle of scientific discovery that a rational strategy is essential to a clear understanding of phenomena and to the creation of knowledge. Engineering processes present a level of complexity with respect to operating variables that contribute to their efficiency and reproducibility and challenge the ability to design experiments sufficiently robust to probe the range of operating conditions to identify optimal parameters.

The approach to statistical experimental design will be described in the next chapter (chap. 18). Several higher-level considerations will be outlined in the following discussion to allow sufficient definition of any process before it is subjected to experimental evaluation.

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