“The issue of GLPs is difficult to put in place for the supplement industry,” said Ed Wyszumiala, president of Wysz Consulting Solutions. “There are best practices that should be in place in any lab, but I think we are still far away from implantation of GLPs.
“Testing supplements is complicated, especially for third party laboratories. There is not to my knowledge a single lab which is an expert in testing all ingredients used in dietary supplements, let alone blends and finished product formulations. Complex product matrices, lack of monographs and reference materials are all challenges facing laboratories.”
“GLPs refer to a different code of federal regulations and not dietary supplements,” explained Elan Sudberg, CEO of Alkemist Labs. “Ultimately I think it is a hindrance in terms of assuring quality across the labs. Having GLPs written by the dietary supplement industry for the dietary supplement industry would certainly be a feather in our cap and only add credibility.
“We (the dietary supplement industry) work in a highly regulated industry that dictates we either send samples for testing or test them ourselves. The basic guidance is that such tests must be scientifically valid. In that lives great opportunity for interpretation that spans the good the bad and the ugly. GLPs could help mitigate the ‘appeal to ignorance’ logical fallacy that many companies use to cut corners with inferior test methods and standards of testing.”
Look for pharmaceutical standards?
GLPs are not mandatory since GMPs require only Certificate of Analysis in many instances, explained Nandakumara Sarma, PhD, director of dietary supplements, U.S. Pharmacopeial Convention (USP). “The lack of GLPs is not a hindrance in terms of assuring quality across labs, provided suitable quality systems are adopted the testing labs,” said Dr Sarma. “One such system is the ISO 17025 accreditation, which demonstrates that the testing and calibration laboratories operate a quality system, are technically competent, and are able to generate technically valid results.”
While there may be no GLPs specific to supplements, it’s more important to perform a quality audit on the contract lab than it is to have all labs trying to comply with specific standards for each industry, according to Karen Letourneau, technical programs manager for POS Bio-Sciences.