Mile High Labs, one of the world’s largest processors of hemp-derived CBD, has announced the successful completion of audits for ISO 9001:2015, 21 CFR part 111 and 21 CFR part 117 certifications. These audits are aligned with the company’s dedication to the highest quality standards for manufacturing.
“CBD manufacturers should hold themselves to the same standards as dietary product manufacturers,” said Stephen Mueller, founder and CEO, Mile High Labs.
Mueller said these certifications are the latest demonstration of how Mile High Labs is leading by example. "We strongly encourage other CBD companies to follow our lead and help create an industry that has good manufacturing practices at its foundation," he said.
The FDA currently does not have regulations in place for the production and packaging of dietary supplements or food containing CBD. As a result, the quality, consistency and purity of CBD products can vary significantly.
ISO 9001:2015 is a standard for quality management systems for companies that operate in a regulatory environment. 21 CFR part 111 is the current Good Manufacturing Practice (cGMP) for manufacturing, packaging and labelling of dietary supplements. 21 CFR part 117 is the cGMP for food.
The standards include requirements for quality systems, personnel, facility, material control, quality oversight and manufacturing controls.
Mile High Labs was audited by SGS America, one of the world’s leading inspection, verification, testing and certification companies. Mile High Labs was audited and certified in 2018 for 21 CFR part 111 and 21 CFR part 117 by Merieux NutriSciences.
Earlier this year, Mile High Labs announced the purchase of a 400,000-square-foot former pharmaceutical plant in Broomfield, Colorado. The fully operational facility allows the company to begin production of finished products such as tinctures, capsules, tablets, topicals, and gummies for private label customers.
The site in Colorado will also provide an environment for advanced training, research and collaboration within the CBD industry.
