Tools

SIDI™ Protocol

The primary goal of the voluntary Standardized Information on Dietary Ingredients (SIDI™) Protocol is to streamline the communication of information on dietary ingredients from ingredient suppliers to finished product manufacturers. The SIDI Protocol details the type and scope of information, in a standardized format, that an ingredient supplier may need 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.

Certificate of Analysis Guideline

The Certificate of Analysis for Dietary Supplement Components Voluntary Guideline (CoA Guideline) is designed to assist with ensuring Certificates of Analysis (CoAs) serve their intended role in the assessment of dietary component qualities or specifications. The voluntary guideline provides recommendations to standardize the content and format of CoAs for dietary supplement components, and it defines suggested roles and responsibilities for component suppliers, distributors, dietary supplement manufacturers and other users who need to meet the dietary supplement cGMP regulation.

NEW: Dietary Supplement Component Supplier Qualification

The purpose of the voluntary Dietary Supplement Component Supplier Qualification Guideline (Supplier Qualification Guideline) is to assist manufacturers of dietary supplements (or other users of dietary supplement components) with compliance with the dietary supplement cGMP requirements, specifically 21 CFR Part 111.75. Recognizing that resources allocated to the process of qualifying suppliers are finite, the guideline’s recommendations are based on the principles of risk management and aim to assist component users with the development of risk-based supplier qualification programs that may be used to help assess the reliability of component suppliers’ Certificates of Analysis and may assist the user in establishing an appropriate testing routine for incoming components.

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.