(325b) The FDA – Novartis CRADA: A Risk-Based and Systems Approach for Quality by Design (QbD) Implementation for An Approved Pharmaceutical Product

The principles of ?Quality by Design? were applied to a commercial drug substance and drug product, in order to implement the FDA driven initiative ?Pharmaceutical cGMPs for the 21st Century?. The Project was also a Cooperative Research and Development Agreement (CRADA) with the U.S, Food and Drug Administration.

In the presentation we will show the application of ICH Q9 for Risk Management. The development of additional knowledge on the various steps of the processes through the use of Design of Experiments and the application of PAT technologies will be highlighted. The interaction with the FDA ? Division of Product Quality Research will be discussed. In the end the interactions between Novartis with the review functions of FDA and EMEA on the supplements that were filed will be discussed.