You can find information about USP’s Verification Program for dietary supplements, dietary ingredients, active pharmaceutical ingredients and excipients here.
USP's Verification Program is a multi-step process. It begins with a pre-audit review, which includes an initial assessment of the manufacturing company's quality system infrastructure. The program is designed to help ensure that critical elements of a manufacturing company's quality systems are in place prior to conducting extensive on-site facility audits, documentation review, and product testing.
- Once the USP Verification Program staff confirms the manufacturing company’s quality systems infrastructure, an on-site audit of the facility and operations is conducted. This audit covers all aspects of manufacturing, from receiving materials to shipping the final product, ensuring system controls and operations are functioning properly.
- After the on-site audit, a review of product quality control and manufacturing documentation is performed on specific lots. These documents must show that products are made according to FDA and USP requirements. The review identifies areas for improvement to ensure consistent product quality.
- Once the documentation review requirements are met, the USP Verification Program staff samples and tests products to verify they meet specifications and label claims. The staff works closely with the manufacturer to resolve any issues during testing.
- If all requirements are met, the product is awarded the USP Verified Mark. To ensure continued compliance, annual market surveillance product testing, documentation review, and facility audits are conducted.
GMPs help create systems that ensure proper design, monitoring, and control of manufacturing processes and facilities. When applied as designed, GMPs help prevent instances of contamination, mix-ups, deviations, failures, and errors. USP offers the following GMP Audit Services:
- Good Manufacturing Practices (GMP) Audit Only Program: USP’s Good Manufacturing Practices (GMP) Audit Only Program for dietary supplement and dietary ingredient manufacturers helps ensure manufacturing sites conform with current Good Manufacturing Practices (cGMPs) based on regulatory and industry standards. The audit is a component of the Dietary Supplement Verification Program (DSVP) and the Ingredient Verification Program for Dietary Ingredients, as a preliminary assessment.
- Good Manufacturing Practices (GMP) Gap Audit Program: The Good Manufacturing Practices (GMP) Gap Audit Program provides a comprehensive current GMP assessment to help a manufacturer or supplier get a better understanding of potential gaps in their production systems. Adherence to current GMP regulations ensures the identity, strength, quality, and purity of products and ingredients to adequately control manufacturing operations.
You can find more information on USP’s GMP Audit Services here.
The USP GMP audit is not a substitute for a regulatory audit, but it will help a participant to prepare for a regulatory audit. USP employs professional certified quality auditors, all of whom have many years of experience, to help ensure that your organization can meet the challenges of a rigorous regulatory audit.
Dietary supplement products that meet the program's strict testing and evaluation criteria are awarded the distinctive USP Verified Mark. The Mark can be used on product labeling, packaging, and promotional materials to help distinguish USP Verified products in the marketplace and aid consumers in their decision-making process. Since the program's inception, the USP Verified Mark has appeared on more than a billion labels/packages of dietary supplements.
To obtain the USP Verification Mark, manufacturers must undergo:
- Manufacturing facility audit for compliance with USP General Chapter <2750> Manufacturing Practices for Dietary Supplements; 21 CFR Part 111 FDA current Good Manufacturing Practices for dietary supplements; and 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food.
- Review of manufacturing and quality control product documentation.
- Laboratory testing of samples of dietary supplements for conformance to product label
- Periodic off-the-shelf testing of USP Verified dietary supplements to confirm that the product continues to meet product label and Verification Program requirements.
USP uses a multi-step, evidence-based process to confirm the accuracy of the information supporting the quality of each product being verified in a particular program. USP Verification includes annual:
- Good Manufacturing Practice (GMP) facility audits, to confirm the manufacturer has the appropriate quality systems needed to ensure product quality.
- Product quality control & manufacturing (QCM) documentation review to ensure quality procedures are consistently being followed and to explore how those procedures provide adequate and appropriate control to ensure continued quality compliance.
- Product testing, which provides assurance that the product conforms to its identity and quality specifications and contains the ingredients listed on the label in the declared strength and amounts.
Verification is not a one-time event. USP annually evaluates the quality of the products through the three-step process of GMP facility audits, product QCM process evaluation, and product testing.
USP's Verification Program addresses the issue of dietary supplement safety in several ways. The USP Verification Program staff evaluate each product's ingredient content. Determining the safety of dietary supplements is a broad undertaking, and includes assessment of drug interactions, contraindications, and side effects. USP's Verification Program only verifies that supplements contain the ingredients stated on the label, in the stated amounts, and that they meet acceptable limits for contaminants such as heavy metals, pesticides, dioxins, furans, PCBs, and microbes. The program also verifies that the products are manufactured using safe, sanitary, and well-controlled procedures. The Verification Program helps protect and inform consumers by providing them assurances that the products with the USP Verified Mark will not contain harmful levels of specified contaminants, toxic botanical species, or greater amounts of active/marker compounds than that indicated on the product specification and label.
USP's Verification Program will not accept a dietary supplement into its program if it does not have the proper performance characteristics (e.g. dissolution or disintegration). Products verified by USP are required to dissolve or disintegrate properly, meeting USP monograph requirements, thereby releasing the dietary ingredients and making them available to be absorbed by the body. USP's Verification Program does not comprehensively address the issue of efficacy of a dietary supplement.
No, USP does not offer any contract testing services. USP extends its testing expertise to participants in its Verification Programs. If you are interested in leveraging USP's fee-based testing services and for additional details or specific inquiries, please contact USP at USPverified@usp.org.
USP does not provide a list of GMP audited sites. It is important to understand that the USP GMP audit is not a substitute for a regulatory audit, but it is designed to assist a participant in preparing for a regulatory audit. USP employs professional certified quality auditors, all of whom have extensive experience, to help ensure the organization is equipped to meet the demands of a rigorous regulatory audit. All USP GMP Audit Program participants can be found here.
USP does not publish testing reports and results of the supplements and ingredients it verifies. However, USP does provide the results and the details of the testing to the participants and/or manufacturers. For further information, it is recommended to check with the manufacturer directly.