A View from the Inside

To get a better understanding of SIDI, I shot off a few quick questions to Kristen E. Blanchard, the vice president of legal and government affairs at Nutramax Laboratories, Inc., a dietary supplement manufacturer based in Maryland and South Carolina.  Blanchard has worked closely with the SIDI working group, and, of course, Nutramax uses SIDI protocol.

When do you envision SIDI being finished? What needs to happen for that to occur?

I believe SIDI will be an ongoing project because it will require review and updates over time. In addition, there is continued work in developing more specific forms and protocols relating to GMPs including supplier qualification guidelines. This should continue to assist industry in becoming more standardized in the forms, documents, and processes they use that support the GMP and the regulatory environment for dietary supplements.

How has Nutramax Laboratories used SIDI in its day-to-day operation?

We have a strong commitment to quality and science. In that capacity, the SIDI protocol is a very important tool to help facilitate gathering of regulatory and quality information from our suppliers of the raw materials we use in our products. We gladly accept and highly encourage our suppliers to use all aspects of the SIDI protocol documents and have been doing so since the early years of SIDI (2007).

Our company has a very robust quality and auditing system for our suppliers. SIDI does not replace on-site physical audits. However, we use the SIDI protocols to communicate with our suppliers during audits and when requesting regulatory and other information. We retain the information received in a consolidated area and allow access to key personnel in departments who require such information.

As an executive at a natural products company, what makes SIDI so useful?

It is an excellent tool to help facilitate communication and the flow of documentation and information that we require from our raw material suppliers. It is also helpful because it standardizes the questions and requirements for each qualified supplier…The ease of gathering information and the ability to detect trends with each supplier (as well as across suppliers) through their answers from year to year is very valuable.

For companies--both newcomers and veterans--that may be reluctant to use SIDI, why should they give it a chance?  

I think there may be a fear from suppliers that it will create more work or it requires new information that currently does not exist. The information that is being requested by manufacturers must be obtained from the suppliers. SIDI protocols simply include a summary of the information already required to conduct business.  The beauty of SIDI is that it provides a consistent format for everyone to use and the information is consolidated into one or two documents. It could eliminate the need for suppliers to provide special certificates or summaries of regulatory information to each individual company. Suppliers could create one or two documents for each ingredient and use that to respond to almost all questions from a manufacturer.