USP's Dietary Supplement Verification Program is a multi-step process. It begins with a pre-audit review, which entails 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. (See Verification Program process graphic.)
- When the USP verification program staff has determined that a manufacturing company's quality systems infrastructure is in place, an extensive on-site audit of the manufacturer's facility and operations is conducted. The audit covers all aspects of the manufacturing operation from receiving materials to shipping of the final product. The on-site facility audit helps ensure that the system controls and operation used to manufacture a product are functioning properly.
- Upon successful completion of the on-site facility audit, an extensive review of product quality control and manufacturing documentation is performed on specific lots of products. These documents need to demonstrate that a manufacturer is producing products according to their specifications, as per the Food Drug Administration (FDA) and USP manufacturing practices requirements. The review of these documents is designed to identify areas of improvement for all aspects of the manufacturing process that helps ensure that a quality product is consistently obtained.
- Once the manufacturer has met the requirements of the documentation review, the USP verification program staff sample a statistically determined number of the manufacturer's products and tests them to verify that they conform to the product’s specifications and ingredient quantitative label claims. This step primarily confirms the observations obtained from the on-site facility audit and review of product documentation. The USP verification program staff works closely with the manufacturer to resolve any issues that may arise during testing. Other testing programs merely report test results.
- If a dietary supplement manufacturer has reached this point in the program, they have met the requirements of the program, and the product under review is awarded the USP Verified Mark. Afterwards, to help ensure that the product continues to meet the requirements of the program, the program staff conducts market surveillance product testing, product documentation review, and manufacturing site facility audits, on an annual basis.
USP's Verification Program is designed to be the most rigorous program currently available. It was created to help dietary supplement manufacturers meet not only FDA current good manufacturing practices (cGMPs) codified in 21 CFR Part 111, but also USP <2750> Manufacturing Practices for Dietary Supplements. When manufacturers enter the program, they are required to submit extensive documentation about their manufacturing operations. The documentation provided by a manufacturer must demonstrate that they have the systems needed to produce quality dietary supplements. USP conducts a six (6) quality systems audit evaluating the manufacturer’s quality management, facilities and equipment, materials, production, packaging and labeling, and laboratory control systems. An on-site facility audit of the manufacturing operation is conducted to help ensure that the systems and controls needed to consistently manufacture quality dietary supplements are in place and are functioning properly.
Upon successfully meeting the requirements of the Dietary Supplement Verification Program, the manufacturer's product is awarded the use of the USP Verified Mark (the Mark). The manufacturer may display the Mark only on specific products that have met all of the requirements of the verification process.
Unlike pharmaceutical drugs with single active components, dietary supplements may contain several dietary ingredients, or might be botanical products that are extremely complex in chemical composition. Proper knowledge, skill, and experience are essential to ensure that accurate results are obtained. USP scientists have extensive experience in evaluating both drug and dietary supplement products. USP has multiple stages of test data review to provide added assurance that the test results and interpretations are accurate
USP's Verification Program addresses the issue of dietary supplement safety in several ways. The USP verification program staff, in consultation with USP's Dietary Supplement Expert Committee, evaluate each product's ingredient content. Those products that contain ingredients that have a known safety risk will not be accepted into the Verification Program. 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 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 the body. USP's Verification Program does not comprehensively address the issue of efficacy of a dietary supplement. The efficacy of dietary supplements is an issue best addressed by FDA.
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.