Oct 25, 2021
For more information regarding Standardized Information on Dietary Ingredients, please visit the SIDI page on chpa.org.
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.
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.
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).
The guidelines are completely voluntary and are not required by law or regulation.
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.
The guidelines are freely available for download on chpa.org.
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.
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.
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.
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.
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.