Validating pharmaceutical systems
This landmark book integrates statistical process control, design of experiments, robust design methods, Shainan's methods and other lesser-known practices into a single system.Professionals engaged in product design, process development, and manufacturing activities will find this common framework has vast practical implications, not least of which is immensely improved communication between the various specializations in the product life cycle.
Design of experiments are a powerful tool for identifying critical to quality inputs and for understanding their effect on the critical to quality outputs (items 3 and 5 of the 5 critical pieces of information for specification setting).
At the heart of this process is the ability to identify the 5 critical pieces of information: From this tolerance analysis can be used to evaluate a design.
Rather than evaluating a single design, thousands of alternate designs can be evaluated and the optimal design determined using robust design criteria.
Taylor has a practical way of introducing statistics including a set questions one should always ask and the classification scheme that makes it easy to identify which statistical procedure should be used.
He also addresses the FDA regulatory requirement for the use of statistically valid methods.
Also performs design optimization simultaneously optimizing the tolerance center and width to obtain high performance robust designs.