What does a USP Verification Program GMP review consist of?
USP’s Verification Program is designed to be the most rigorous program currently available. It was created to help dietary supplement manufacturers meet USP’s manufacturing practices for dietary supplements, and proposed FDA good manufacturing practices (GMPs). 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 quality assurance (QA) systems needed to produce quality dietary supplements. USP evaluates the QA systems, which consist of 15 different program elements that address matters such as employee training, document management, equipment calibration and maintenance, manufacturing and laboratory control procedures, and product shelf life evaluation. An on-site audit of the manufacturing operation is conducted to ensure that the QA systems are functioning properly.
