FDA has signaled this past summer that it will toughen its stance on the degree to which drug manufacturers must oversee and audit the activity of their vendor partners. In a presentation at Xavier University in June, CDER's Brian Hasselbalch outlined the myriad drug quality issues that have sprung from the globalization and outsourcing boom taking place in the industry, and FDA's lack of resources and inability to police such activity appropriately. The Agency expects to make updates to cGMP's in the near future to reflect this new position.
International Pharmaceutical Quality reported on the presentation earlier in the summer, while Teresa Jaworski, senior validation specialist, provides an excellent overview from QPharma's Validation and Regulatory Compliance blog.
--Paul Thomas
