Frequently Asked Questions

1. What is vendor/supplier qualification?
Vendor or supplier qualification is the process of determining the acceptability of a potential vendor or supplier, ingredient or component for use in the manufacture of a dietary supplement. Qualification may be based on the prospective supplier demonstrating: experience in providing material that meet company specifications and standards; financial and operating stability; and the adequacy of its facilities, organization, and location. In the context of the dietary supplement cGMP (21 CFR Part 111.75), proper vendor or supplier qualification is required for a manufacturer that opts to rely on its supplier’s Certificate of Analysis for all specifications (except identity) in lieu of conducting its own tests and examination of the ingredient(s) or component(s)  supplied.

2. What is the purpose of the guidelines?
The guidelines were developed as voluntary tools to assist dietary supplement manufacturers and ingredient or component suppliers with the supplier qualification process. Each of the guidelines focuses on different aspects of qualifying a supplier, and together, they are intended to help companies develop their own supplier qualification programs for compliance with the dietary supplement cGMP regulation.

3. Who developed the guidelines?
The guidelines were developed and are maintained by the SIDI Work Group, a collaboration of three dietary supplement trade associations and expert volunteer member company representatives. The trade associations include: the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA).

4. Is use of the guidelines required?
The guidelines are completely voluntary and are not required by law or regulation. 

5. Why should I use the guidelines?

The guidelines represent tools available for the dietary supplement industry to assist with GMP compliance, now required for dietary supplement manufacturers of all sizes. The guidelines promote a risk-based approach to supplier qualification which may allow for optimal allocation of time and resources to the supplier qualification process.

6. Is there a cost to use the guidelines?
The guidelines are freely available for download on our website, www.sidiworkgroup.com. Users will be asked to complete a one-time registration.

7. Why do I need to register to download the guidelines?
Users are asked to provide basic contact information upon the first attempt of downloading a guideline on www.sidiworkgroup.com; this is to help us inform users of updates and revisions to the guidelines.  Contact information will not be used for commercial purposes.

8. How are the guidelines organized?
The Supplier Qualification Guideline is the umbrella document that outlines the main aspects of supplier qualification based on the principles of risk management. Within this guideline, complex areas in need of additional guidance (such as documentation and Certificates of Analysis) are highlighted and detailed in separate guideline documents (e.g. SIDI protocol, CoA Guideline).  Additional guidelines may be developed depending on need.

9. For whom are the guidelines intended?
The guidelines may be useful for all members of the supply chain, from ingredient or component suppliers, to distributors and finished product manufacturers. They may be used to help develop in-house supplier qualification programs or standard operating procedures. The degree to which the guidelines are relied on may depend on the type of company and/or individual users. It is recommended that all company departments, including quality control/assurance, regulatory affairs, legal, purchasing/procurement, manufacturing/operations and marketing at least review and become familiar with the guidelines. 

10. What information is contained in the SIDI Protocol?

The SIDI Protocol stands for Standardized Information on Dietary Ingredients (SIDITM) protocol and details the type and scope of information, in a standardized format, that an ingredient supplier typically needs to provide to a manufacturer, as opposed to non-standardized, customer-specific questionnaires. The information provided in a SIDI document may be used to help fulfill documentation aspects of ingredient supplier qualification.

11. What information is contained in the Certificate of Analysis Guideline (CoA Guideline)?
This Guideline provides recommendations to standardize the content and format of CoAs for dietary supplement components, and it clearly defines the roles and responsibilities for component suppliers, distributors, dietary supplement manufacturers and other users who need to meet the dietary supplement cGMP regulation.

12. What information is contained in the Supplier Qualification Guideline?
This Guideline provides the overarching framework of supplier qualification that is based on risk management principles and provides recommendations for the different components of the process, including audit assessment, documentation, CoA confirmation and re-qualification.

13. How can I get involved?
Representatives of companies that are members of any one of the participating dietary supplement industry trade associations with appropriate expertise are encouraged to participate in the SIDI Work Group.  Further, any interested individual is welcome to comment on the draft SIDI Work Group voluntary guidelines once the draft document is posted on the website for review. Contact us at info@sidiworkgroup.com for more information.

14. How/where can I learn more about the guidelines, how they are being used and the ongoing efforts of the SIDI Work Group?
The SIDI Work Group conducts outreach/education presentations at industry trade shows and meetings. See our "News" section for a list of upcoming events.

15. Do the guidelines have international application?
The guidelines are currently applicable to U.S. regulations. They may be revised to support international companies in the future.

16. For which languages are the guidelines available?
The guidelines are currently available in English only.

17. Where can I get help with using the guidelines?
Feel free to ask your questions on the guidelines by emailing info@sidiworkgroup.com.

DISCLAIMER: These voluntary Guidelines are for information purposes only and intended to assist users with compliance with the cGMPs for Dietary Supplements, 21 C.F.R. § 111. The Guidelines should not be utilized as a substitute for compliance with all applicable laws and regulations. The Authors make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, or suitability of the Guidelines for any purpose. By use of these resources, the user agrees not to hold the authors liable or responsible for the user’s compliance with all applicable laws and regulations. CLICK HERE TO READ FULL DISCLAIMER.

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