Dietary Supplement Testing
The U.S. Food and Drug Administration (FDA) promulgated its Good Manufacturing Practices (cGMP) for Dietary Supplements to law as part of 21 CFR 111 in 2010. However, the onus is on the manufacturer to develop meaningful standards for dietary supplement testing that will stand up to an FDA GMP audit.
Microtest provides a complete portfolio of analytical, microbiological, and product stability testing services that ensure dietary supplement GMPs are achieved. These include tests for antimicrobial effectiveness, non-sterile products for specified microorganisms (E.coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, etc.), and microbial limits for supplements and products. Microtest's chemistry and manufacturing controls testing includes raw materials analysis, supplement disintegration and dissolution, final product analysis, and method validation.
Dietary supplement manufacturers' new paradigm is one of testing, manufacturing, and lot release similar to pharmaceutical manufacturing. As a leading contract pharmaceutical manufacturer, Microtest has deep experience testing supplements for compliance to GMPs. With 50,000 square feet of laboratory and manufacturing space, and the latest technologies, we can perform to the most rigorous dietary supplement testing requirements.
Complying with the spirit and intent of the cGMPs can be a challenge for small- and medium-sized dietary supplement manufacturers. Outsourcing the majority of the testing may make economical sense for these firms. Microtest is uniquely positioned to fulfill these needs.