FDA & IPEC Work on Excipient Screening

In an attempt to speed up its monitoring and surveillance of the pharma supply chain, the FDA has approached industry group IPEC Americas for help with excipient authentication. The goal is to develop a quick first-level screen that can identify samples requiring further screening.

For the initial screen, FDA inspectors would use portable devices based on X-ray and various spectroscopy technologies. They will look for metals and other contaminants, but also will compare scan results against spectra from known-good excipients. The authentic spectra database will be supplied by IPEC's Excipient Qualification Committee.