GMP CBD Manufacture from Hemp – Good Manufacturing Practice2018-12-14T00:55:22+00:00

GMP CBD Manufacture from Hemp – Good Manufacturing Practice

CBD (Cannabidiol) is the naturally occurring cannabinoid found in hemp used medicinally, pharmaceutically and as a nutraceutical or natural food additive. Nutraceutical and Pharmaceutical grade CBD extraction from hemp is driving innovation and investment in the cannabis industry at much larger scales than what we see in the medical cannabis industry.

CBD Manufacture requires large scale GMP Hemp Processing Facilities

While GMP medical cannabis extraction equipment for medical cannabis is typically at a 10-100 kg per day scale, Rhizo Sciences is increasingly being approached by pharmaceutical industry or food industry backed groups to develop GMP hemp processing facilities for GMP CBD extraction of 100s or 1000s of kg per day.

 

Demand for GMP CBD Growing Rapidly

Renowned for it’s anti-inflammatory, anti-anxiety and numerous actions, CBD, is quickly emerging as a powerful new drug and wellness supplement.

Unlike THC – the main cannabinoid responsible for the “high” in cannabis, CBD is non-intoxicating and psychedelic. That makes it more attractive to many patients and health professionals as well as regulators than THC.

Because it can be extracted from hemp that is low in THC (hemp is defined in most countries as having <0.3% THC) CBD often has a different legal status to medical cannabis. In fact the WHO (World Health Organisation) recently endorsed CBD because their studies found it is safe, effective for some conditions, and not likely to be abused. As a result there has been a global shift toward de-scheduling CBD and a massive increase in demand for CBD and investment in cultivation facilities.

Shortage of GMP CBD Processing Facilities

While hemp is cannabis, hemp plants tend to have more fibre, wax, oils and other impurities that require a more industrial approach to processing, extracting and refining hemp under GMP conditions.

The quality of the input material is paramount too – hemp varies widely from industrial strains with low levels of THC to more drug-type high CBD hemp ideal for extraction. The quality of the crop is essential – hemp used for GMP processing into medicines should be produced under GAP – Good Agricultural Practice – just as you would expect for any medicine or food. For truly pharmaceutical grade GMP CBD manufacturing standards will be even higher – with indoor or greenhouse cultivation required – you can’t make quality medicine unless you can ensure that the hemp is free from fungi, microbes, heavy metals, pesticides or other contaminants.

Currently most CBD available on the market lacks effective quality control and is poorly regulated. In the USA, which is the largest producer of hemp-derived CBD, the FDA (Food and Drug Administration) has avoided regulating hemp and cannabis manufacturing meaning that most hemp processing occurs in garage labs that would never pass normal standards expected for other foods and drugs – such as GMP, HACCP or food grade quality standards. This is unacceptable for a medicine, and won’t last.

FDA Cracks down on CBD Manufacturers for lack of GMP compliance

The FDA has already issued warning letters to non-GMP manufacturers making hemp derived products without suitable equipment, processes and controls.

We can expect this intervention to expand dramatically with as hemp becomes a regulated product with the successful passage of the farm bill.