Supplier Qualification Session Fills Room

LAS VEGAS--A full room of SupplySide West attendees heard a panel discuss supplier qualification and the progress of the SIDI (Standardized Information on Dietary Ingredients) Protocol program. The Oct. 21 panel included Harry Rice, Ph.D., director of regulatory and scientific affairs at the United Natural Products Alliance (UNPA), Mike Bradley, director of scientific affairs-nutrition at Perrigo Company, and Anthony Palmieri, market segment head for infant/toddler nutrition and medical foods at DSM Nutritional Products.

We need to gain control over our supply chain," Rice began. The question is how?"

Bradley discussed expectations of supplier qualification from a manufacturers perspective, including benefits to the manufacturer. He outlined risk factors to consider in qualifying a supplier, such as country of origin, supplier regulatory history, supplier experience, and supplier audit results. Bradley made the point that using a risk-based assessment model allows the application of resources to the highest risk suppliers. He also emphasized the need for the industry-wide SIDI efforts in order to set common standards and practices. If we have a diverse set of practices, FDA will take the highest standard and continue to raise that bar until we hit the drug standards," he said.

Palmieri followed up by giving the suppliers perspective. He said that a risk based assessment of suppliers helps to differentiate between high risk, low price suppliers and low risk, high price suppliers. He gave the example of how serious a mistake can be by explaining that 1 kg of vitamin A can end up in infant formula consumed by 9,000+ babies. Cheap ingredients may not be so cheap after all," he warned.

The SIDI protocol is an effort to develop standardized practices for the information that suppliers provide to manufacturers, for information contained in certificates of analysis, and for best practices in supplier qualification. Additional information about the SIDI Protocol is available online.