FDA’s Rosa Motta spoke this morning at ExcipientFest 2010, presented this year by IPEC, about supply-chain security. “I feel like I’m preaching to the choir because if you’re here, you’re already interested in controlling your excipients and your supply chain,” she told the audience gathered in San Juan, Puerto Rico.

Motta went on to highlight the stats industry has heard many times—40% of drugs consumed by Americans are imported and 80% of APIs are manufactured outside the US. Contamination and adulteration keep growing, with 788 deaths caused by DEG contamination alone since 1937. But propylene glycol and glycerin aren’t the only ingredients industry needs to keep a careful eye on, Motta pointed out. All it takes is a willing buyer looking for a lower-cost ingredient and a lack of interest in quality or integrity for another fatal crisis to occur.

To keep supply chains in check, Motta listed a few to-do items for pharma manufacturers. Among the list: conduct specific ID tests, make products traceable, be transparent—use real information and accurate data, avoid over-relying on CoAs, have a quality agreement for each supplier, take corporate responsibility into consideration, and perform audits.

On the latter point, one audience member questioned how far a company needs to go with auditing—does it really need to audit every single supplier and distributor? Yes, said Motta. FDA supports a risk-based, sound approach to auditing, she said, but if your company has never visited a particular site, that site is then your highest risk, she explained. This explanation makes the idea of third-party audits inevitable. If a company must have some sort of site visit and qualified audit report for every single supplier and distributor it uses, the number of audits is going to increase tremendously—and rightly so. Manufacturers cannot rely on regulatory audits which may be less frequent or not cover the company’s particular process of interest. Also out the door noted speaker Eric Berg of Amgen in a separate session are paper and mail audits–site audits of every supplier are now a must do.

Of note, Motta said FDA is still establishing an official position on the use of third-party audits and outlining specific expectations for their use. She went on to note  a few new ideas in supply-chain security. The idea of photo libraries seems to be a growing hot topic. Although FDA does not have an official position on this yet, Motta mentioned it as a good, innovative idea. Currently, Amgen and Baxter are using these libraries at their warehouses to identify key components of the product such as tamper-evident tags. Conference participants pointed out that it would also be critical for the warehouse staff to have proof of photo authentication when using these libraries.

FDA is also working to improve its rapid screening tests at the borders. Overall, there seems to be more concern among industry to not let contaminated products into the country by coming up with new and better tracking and detection methods during the distribution/receiving phases. Still, one audience member noted that manufactures should not overlook the information and tools they already have on hand. For instance, he pointed out, the DEG contamination in Panama could have been prevented by one simple identification test that has been around for 60 years. Nothing fancy or new was needed—just responsible follow-through.