Information flow between ingredient supply companies and dietary supplement finished product manufacturers is becoming increasingly important — and scrutinized — as a result of new supplement good manufacturing practice (GMP) rules. In fact, according to Andrew Shao, Phd, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN), FDA auditors are asking during their GMP inspections how manufacturers obtain information from their ingredient suppliers and how they are using that information to qualify those suppliers.
Improving and making more efficient the flow of information from supplier to manufacturer are the chief objectives of the Standardized Information on Dietary Ingredients (SIDI) protocol, which was created in 2005 by CRN, the American Herbal Products Association (AHPA), the Consumer Products Healthcare Association (CHPA) and the Natural Products Association (NPA). The SIDI protocol provides an outline representing the type and scope of information that a supplier typically needs to provide to a manufacturer, including how an ingredient was manufactured and whether allergens are present or may have come in contact with the ingredient. The idea is that suppliers will voluntarily use the SIDI template — which can be downloaded via the CRN Website (www.crnusa.info/SIDI/) at no charge — to standardize and streamline the information they provide to manufacturers, Shao said.
Although SIDI was not designed with GMPs in mind, it can be a useful tool in helping supplement manufacturers comply with the new rules. “As it turns out, a manufacturer must know all of the information [outlined in the SIDI protocol] to qualify a supplier,” Shao said. “A quality-focused supplier will be able to provide this information very easily, whereas a supplier that doesn't have any quality-control practices in place will have a hard time. SIDI makes it easier for manufacturers to differentiate between quality suppliers and those pretending to be.” That said, SIDI forms or other questionnaires filled out by suppliers are not enough to fully qualify a supplier. “You must audit them,” Shao said. “SIDI does not replace an on-site audit.”
Shaheen Majeed, marketing director for ingredient supplier Sabinsa Corp., said his company has created a SIDI document for each of its more than 50 branded, patented ingredients. Travis Borchardt, vice president of regulatory affairs and quality systems at supplement manufacturer Enzymatic Therapy, said his company accepts the SIDI documents and believes the program is a “step in the right direction” for the industry. “I would prefer if suppliers went to one standaridized format,” he said. “That would make everyone's lives easier.”