(325c) QbD – Design Space Management / Maintenance

Design Space Management is very important in the product lifecycle as there are several issues to be addressed.

The first issue is of course the fact that the design space is expected to evolve after the initial submission as more data become available. Evolution of the Design Space may also mean an evolving control strategy; it is expected that more data and increasing process knowledge would result in better (and smarter) control of the process.

Other issues include change of scale, site transfer, change of suppliers for API and excipients, change in the covariance of the raw material characteristics within the same supplier.

Intentional changes, like opportunities to use soft sensors instead of PAT, or to expand the current PAT capabilities, should also be considered.

This work deals with solutions to problems that can be addressed under the framework of design space management. It demonstrates that a systematic methodology for maintenance will enhance confidence on the design space.