A Global Perspective on Technology Transfer for Analytical Sciences

Abstract

Moving through the many phases of drug development, from the identification of a candidate molecule for development to the filing and approval of a license to market a product, analytical and microbiological control methods and the associated techno/ogy for both drug substance and product may undergo many changes. Zn a world where globalization leads to this process and to the subsequent commercialization of product being executed on a number of different sites worldwide, the effective and efficient transfer of analytical and control technology is a critical factor in ensuring consistent quality standards. In order to maximize the efficiency of the analytical technology tramfer, it has been necessary to reconsider some of Sterling Winthrop’s traditional ways of doing business, and in collaboration with colleagues in both research and manufacturing, additional changes are to be introduced to further streamline the process. Demonstrating the effectiveness of the technology transfer process, a matter of some importance at the time of Food and Drug Administration (FDA) preapproval inspections, is an area where further opportunities for improvement are still available.