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.
Use of the rapid first screen will hopefully increase the number of containers that each FDA agent can check. CDER is currently evaluating and field testing portable scanners to determine sensitivity levels.
Separately, IPEC is seeking comments on its EXCIPACT plan, an audit scheme for certification of excipient manufacturers and suppliers.
- here's the story
- see the IPEC review/comment request