Concurrent with the U.S. Food and Drug Administration’s final rule establishing regulations to require current good manufacturing practices (cGMPs) for dietary supplements, PTL can offer cGMP services to all supplement manufacturers. PTL has sustained its FDA registration since 1994, which involves rigorous inspections by FDA every 2 years or sooner. According to the final rule, proper controls must be in place for dietary supplements to be produced in a consistent manner for identity, purity, strength, and composition.

PTL’s particle characterization tests can be conducted following FDA regulations. Valuable testing such as particle size and shape, image analysis, B.E.T. surface area, pore volume and pore size can be analyzed under cGMP compliance. These analyses can give insight into absorption, strength, and composition of the material being processed.

The final ruling also states that the products must meet quality standards. PTL’s internal Quality Assurance Unit (QAU) is dedicated to maintaining a compliant quality system per cGMP regulations. The QAU is the keystone for not just upholding PTL’s current quality system, but for updating quality standards according to newer FDA rulings.

In summary, PTL can act as an extension of your company when contracting out particle characterization testing under cGMP regulations. Our comprehensive physical testing lab, coupled with a diligent Quality Department, ensures confident results.

Common Samples:  Dietary Supplements, Vitamin and Mineral Supplements, Herbal Supplements, Amino Acids, Metabolites

Analytical Testing:  Particle Size, Surface Area, Image Analysis / SEM, Flowability Studies, DSC / TGA, Porosimetry

PTL's laboratory is cGMP compliant, registered with the FDA and holds a DEA and ATF permits. PTL's consulting solutions open up the full range of what is possible in a dietary product particle testing method. Click here to request a quote or for more information.