Jan 19, 2022
This is a Standardized Information on Dietary Ingredients (SIDI) Work Group document.
This document serves as a voluntary guideline to assist manufacturers of dietary supplements (or other users of dietary supplement components) with compliance with the dietary supplement current good manufacturing practice (cGMP) requirements of the US FDA 21 CFR §111. The Component Supplier Qualification Voluntary Guideline, referred to hereafter as “the guideline,” is intended to assist component users with the development of their own risk-based supplier qualification programs. These programs can be used to help establish the reliability of the component supplier’s certificate of analysis (COA), which may allow the component user to justify reduced testing of incoming components.13 The guideline also serves to educate component suppliers on the expectations for supplier qualification. Broad use of this guideline across the dietary supplement industry can play a key role in helping to maintain the integrity of the supply chain, ensure cGMP compliance, and help serve in protecting the public health.
This guideline may be applicable to all dietary supplement components used in the manufacture of a dietary supplement product. It provides recommendations to comply with the regulatory requirements of component supplier qualification and may be utilized by finished product manufacturers or other users of dietary supplement components to build the foundation for a supplier qualification program.
This guideline focuses on compliance with US regulations, but it also has international application, as components used in the manufacture of dietary supplements are sourced globally and are encompassed by many different government regulatory systems. When considering how to use this guideline, each component supplier, distributor, or component user should consider how the guideline might apply to its particular circumstance. The diversity of components and products and their uses, along with the global nature of the supply chain, make it so that some principles of the guideline may be more or less applicable to certain components or products than others.