chapter  8
32 Pages

Efficient and Effective Process Development Work: The Key to a Successful Validation Study

ByJeffrey T. Field

Reducing the amount of time required to properly develop, scale-up, and optimize a new process and/or product is absolutely critical and directly related to the competitive position of any business. Thus, it is important that all product development work be performed in a highly efficient and cost-effective manner. Initial product development work must identify the critical inputs to a manufacturing process and set proper specifications for these variables. In addition, if the process is shown to be robust, the tolerances on noncritical variables can be widened.