SIDI Article
SIDI Article
SIDI Article
“Not only can vitamin and mineral companies rely on SIDI, it can be applied to botanicals as well since the protocol
includes a separate sub-section to address botanical ingredients,” said Dr. Shao.
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mailing list So what are these guidelines? The SIDI protocol includes three standardized sections—Product Information Data
Sheet, Site Quality Overview and Supply Chain Security Overview—along with a comprehensive glossary containing
definitions of key terms and links to relevant websites.
subscribe Intended to facilitate the use of the ingredient in finished products, the Product Information Data Sheet includes
unsubscribe important physical/chemical, labeling, manufacturing, regulatory and miscellaneous product information specific to the
ingredient. The Site Quality Overview assists in evaluating the manufacturing practices and quality systems of
Submit ingredient suppliers. Intended to address the foundation of the requirements, this section communicates the level of
quality control employed at a supplier’s site. The final section, the Supply Chain Security Overview, is designed to
provide manufacturers with information concerning the ingredient supplier’s plans to ensure the protection of the
product (i.e. compliant with bioterrorism act, security systems in place) and the continuity of supply.
The first section of the protocol, Product Information Data, is available at the websites of the participating trade
associations. The final two sections are under review and will be posted in the coming months. Once all three sections
have gone through review, SIDI will be provided to the FDA for comment (unofficial statements from the agency
suggest the protocol is an excellent idea).
In addition to the guideline documents, there are blank example template forms as well as completed sample forms to
serve as examples for users. The protocol is not designed to address every possible piece of information that a
manufacture might desire for a given ingredient; it provides the basic type and scope of information that ingredient
suppliers should consider providing to their customers. If the manufacturer desires additional information, it can be
requested and provided separately in the form of a separate attachment or cover letter.
The potential advantages of using the SIDI Protocol are industry wide, benefiting the manufactures, ingredient
suppliers and even consumers. Manufacturers may now be able to receive consistent and updated information from
multiple suppliers, therefore being able to quickly retrieve/interpret information and achieve a reduction/reallocation of
costs/resources. Other benefits for manufactures include change control; more accessible information to FDA;
facilitation of FDA or other third party audits (all information is already assembled); and smoother merger/acquisition
transitions. From the ingredient suppliers’ perspective, they may now able to complete information packages in a
standardized format (rather than filling out countless differing questionnaires), reducing completion time and
increasing accuracy of information. Other advantages include change control/notification and liability risk is potentially
reduced. Additionally, since standardization of any process can reduce risk of error, SIDI has the potential to benefit
consumers as well. A more organized system of vendor qualification could increase safety/quality of the products
consumers purchase.
Moving away from individualized questionnaires toward standardized documentation will represent a major shift for
the industry, and Dr. Shao understands that acceptance won’t be easy. “The issue is that manufacturers are
accustomed to developing and providing their own questionnaires. It’s a major paradigm shift because people are
used to using the same procedures,” he said. “Suppliers will need to begin compiling their information as their
ingredients go through the product development process and as specifications are developed. They need to add that
data into their information package, so that at launch and post-launch, the package is ready and available to be
provided to customers.” Manufactures also need more departments reviewing and signing off on the information
package than just the purchasing manager. It’s a more collaborative and interactive effort on both ends than it
probably is today.
“The more it gets adopted and implemented, the easier it will be for manufacturers to use instead of sending out their
own questionnaire,” commented Dr. Shao.
Overall, SIDI’s main goal is to streamline information exchange between suppliers and manufacturers, thereby helping
to identify and properly qualify supplement ingredients from trustworthy sources. So although use of the SIDI protocol
is completely voluntary, and there is no means of enforcing its use, companies are strongly encouraged to rely on it.
“All we can do is provide the guidelines to the industry and hope they will adopt the concept and implement it on their
own,” said. Dr. Shao. “The trade associations and companies that have been involved in the intensive process believe
the SIDI protocol is a more effective, efficient, forward-thinking approach to communication between suppliers and
finished product manufacturers to assure affordable quality product for consumers.”
*Interested parties can access SIDI through the four trade associations’ websites: www.ahpa.org, www.chpa-
info.org, www.crnusa.org and www.naturalproductsassoc.org.*