BOULDER, Colo. – Mile High Labs, one of the world’s largest processors of hemp-derived CBD, today announced the successful completion of audits for ISO 9001:2015, 21 CFR part 111 and 21 CFR part 117 certifications. These audits further demonstrate 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. “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.”
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 labeling 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.
In June 2019, 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. It will also provide an environment for advanced training, research and collaboration within the CBD industry.
The International Organization for Standardization (ISO) is “an independent, non-governmental international organization with a membership of 164 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.”
ISO creates standards but does not certify companies.
ABOUT MILE HIGH LABS
Mile High Labs is a large-scale CBD ingredient and product manufacturer offering reliable delivery of bulk CBD and private label services to the world’s leading consumer brands. With a GMP-certified facility and extensive network of contracted cultivators, Mile High Labs supplies high-quality, high-volume CBD orders year-round. Mile High Labs extracts exclusively from industrial hemp material.