FDA USE OF OUTSIDE PARTNERSHIPS
This article was originally published in The Gold Sheet
Executive Summary
...is expanding to help meet the challenges of implementing a new quality review paradigm. The new collaborations are designed to help the Office of Pharmaceutical Science build a stronger knowledge base to support the agency’s Critical Path and 21st Century GMP initiatives. CRADAs have been reached with consultants to assess where firms are on the quality-by-design spectrum and how FDA can best support further progress and leverage the knowledge gained. A multi-university consortium is working with the agency to help fill the needs in basic manufacturing research and human resource development. Contract support is also being used by FDA to refine its own internal quality management system for the CMC review process. Meanwhile, research by a pair of academics has produced results which are helping FDA refine its risk-based inspection model and manufacturers better manage their quality practices.