AGAWAM, Mass.— Microtest Laboratories posted a free white paper, “Dietary Supplements—A New Paradigm for Manufacturers,” detailing information on complying with federal dietary supplement GMPs (good manufacturing practices). The white paper provides an overview and discussion of FDA requirements, including guidance on developing quality systems, microbiological testing and practices, and chemistry and manufacturing controls.
“Today, there’s a new paradigm for dietary supplement manufacturers—and it’s one of testing, manufacturing and lot release,” said Steven G. Richter, Ph.D., president/chief scientific officer of Microtest Labs, and author of the white paper. “cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions.”
Richter noted the testing requirements may be challenging for small- and medium-sized manufacturers. “Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs,” he said. “The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer. … Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support.”
