During the development and production lifecycle of any pharmaceutical product, the manufacturing process generally goes through several iterations designed to improve quality, consistency, throughput, cycle time, and cost. A key enabler for facilitating these types of improvements is the synchronization of well-understood Design and Control Spaces. When the Control Space and the Design Space are being established in conjunction with one another, there will be fewer incompatibilities between the process and equipment and thus fewer problems during process installation, validation, production operations, process optimization, and future site-to-site transfers.

This presentation proposes a methodology based on capturing performance and design data from existing Manufacturing unit operations and using these results to help establish the Design and Control Spaces for new products.