GMP CBD Manufacture from Hemp – Good Manufacturing Practice

CBD (Cannabidiol) is a naturally occurring cannabinoid found in hemp, commonly used in medicinal, pharmaceutical, and nutraceutical products, as well as a natural food additive. The demand for pharmaceutical-grade CBD extraction from hemp is driving significant innovation and investment in the cannabis industry, especially at larger scales compared to the traditional medical cannabis sector.

Large-Scale GMP Hemp Processing Facilities are Key to CBD Manufacture

While typical GMP medical cannabis extraction systems operate at scales of 10-100 kg per day, the hemp industry is rapidly scaling up. Rhizo Sciences is increasingly approached by food and pharmaceutical industry-backed groups seeking to develop GMP-compliant hemp processing facilities capable of handling 100s or even 1000s of kg per day for GMP-grade CBD extraction.

The Rapid Growth in Demand for GMP CBD

Renowned for its anti-inflammatory, anti-anxiety, and numerous therapeutic properties, CBD is quickly becoming a powerful new compound in the health and wellness space. Unlike THC, the main cannabinoid responsible for the psychoactive “high” associated with cannabis, CBD is non-intoxicating. This makes it more attractive to a wider audience, including patients, healthcare providers, and regulators.

CBD can be extracted from hemp, which is legally defined in many regions as cannabis containing less than 0.3% THC. This has led to CBD having a different legal status than medical cannabis. The World Health Organization (WHO) has endorsed CBD, concluding that it is safe, effective for certain conditions, and poses little risk of abuse. This endorsement has led to the global de-scheduling of CBD and a massive surge in cultivation and processing facilities.

Shortage of GMP CBD Processing Facilities

While hemp is a form of cannabis, it tends to contain more fiber, wax, and impurities, making the GMP processing and extraction of hemp more complex. High-quality input material is essential for producing pharmaceutical-grade products. The quality of the hemp crop must meet strict standards, especially for high-CBD hemp flower cultivated for extraction.

For GMP CBD production, crops should be grown under GAP (Good Agricultural Practice) standards, ensuring the hemp is free from contaminants like fungi, heavy metals, pesticides, and microbes. True pharmaceutical-grade CBD production requires even stricter control over cultivation conditions, often demanding indoor or greenhouse environments.

Currently, much of the CBD on the market lacks proper quality control and regulation. In the United States, the FDA has not yet fully regulated hemp and cannabis manufacturing, leading to unregulated hemp processing in facilities that often do not meet food-grade or pharmaceutical-grade standards like GMP or HACCP. This is a significant issue for a compound increasingly used for medicinal purposes.

FDA Enforcement on Non-GMP CBD Manufacturers

The FDA has already begun cracking down on non-compliant CBD manufacturers. Several manufacturers have received warning letters for failing to meet GMP standards in their hemp-derived product processing. The FDA is expected to increase enforcement efforts as the hemp industry becomes more regulated with the passage of the U.S. Farm Bill.

Meeting the Growing Demand for GMP CBD

As demand for CBD continues to rise, so does the need for large-scale GMP-compliant processing facilities. With the regulatory environment tightening, the importance of adhering to GMP standards in both cultivation and processing cannot be overstated. Failure to comply could result in regulatory penalties, product recalls, and reputational damage.

At Rhizo Sciences, we specialize in developing and scaling GMP-compliant CBD manufacturing processes that meet the stringent requirements for pharmaceutical and nutraceutical products. We help companies build and operate state-of-the-art facilities that adhere to the highest standards of quality control, ensuring the consistent production of safe, effective CBD products.

Learn More

For more information on how Rhizo Sciences can help you establish or upgrade your GMP CBD processing facility, visit our CBD Manufacturing Services page or contact us for a Wholesale CBD Enquiry.