PQLI Control Strategy Model and Concepts

Abstract

This paper describes an approach and technical process for developing and implementing a Control Strategy, which is a planned set of controls, derived from current product and process understanding that assures process performance and product quality. Development of a Control Strategy requires a structured process, involving a multi-disciplinary team of experts, linking pharmaceutical development to the manufacturing process, and engineering controls of process equipment. The PQLI Control Strategy Team has proposed a Control Strategy Model that facilitates understanding and that may be used a cross-functional communication tool. This paper concentrates on the techniques and principles involved in developing the early Control Strategy rather than the operational implementation of the strategy.

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