GMP CBD Extracts
GMP CBD Extracts from hemp (Cannabis sativa with <0.3% THC) are currently the most sought after cannabis derived product. As mainstream companies from the pharmaceutical, nutraceutical and food and beverage sectors realise the value of CBD as an ingredient in health, wellness and medical products they require quality product that has been manufactured to the same standards required for every food and medical product.
Types of CBD Extracts: Oil, Distillate, Isolate
CBD hemp extracts come in many different formats depending on the source material type, quality and potency, as well as the extraction method, equipment and refinement process used.
Types of GMP CBD Extraction
Most GMP CBD extracts are produced using standard pharmaceutical or botanical extraction processes with supercritical CO2 and Ethanol extraction being well represented. Hydrocarbon extractions (such as butane) are rarely used. Other novel methods based on water or ultrasonic extraction are also in development.
Equipment used must be GMP compliant, ruling out most popular cannabis industry extraction brands.
To produce a GMP product the extraction process must follow GMP cannabis extraction processes in a GMP certified facility.
Crude Hemp Extract
The crude CBD-rich oil extracted from hemp typically cannot be GMP due to variations in consistency between batches and the presence of impurities which limit shelf life, discolour the product and add taint the natural hemp flavours. Hemp has a distinctive herbal, aromatic smell and flavor that varies significantly according to the cultivar just as other cannabis does. Most high CBD hemp genetics on the market currently have a characteristic cherry, berry or floral bouquet but there is a wide range of options.
It is normally further refined to remove impurities such as waxes and pigments.
Depending on the extraction method used crude hemp oil is typically 25% or more in CBD content if extracted from normal industrial hemp, or 50% or more if extracted from high CBD medical hemp.
GMP Winterised CBD Oil –
Winterised CBD hemp oil is a clear golden oil which has had waxes, pigments and other impurities removed through treatment with ethanol, heat, cold, filtration and other processes.
Note that winterisation is not necessary if using ethanol extraction, but alternative refinement processes are available to remove pigments and impurities.
Winterised CBD oil typically has CBD content of 40% to 60% or higher depending on the source material and the extraction and cleaning processes.
The extract stages of processing allow standardisation of the product and a strict GMP process.
GMP Winterised CBD Oil should have a consistent CBD content and terpene profile from batch to batch.
GMP Winterised CBD Oil is suitable for use in tinctures, edibles, topical products, capsules and other uses where a strong hemp flavour is acceptable.
For other uses further refinement through distillation is required.
GMP CBD Distillate
GMP CBD Distillate is a clear light golden liquid, though it may be solid at room temperature depending on composition.
CBD Distillate is obtained by distilling CBD oil to concentrate the CBD and remove impurities.
CBD Distillate typically has CBD content of 80% or higher depending on the source material and type of distillation and the number of passes.
Double distilled CBD distillate may have a CBD content of 90% or higher.
GMP CBD Distillate should have a consistent CBD content and terpene profile from batch to batch.
CBD Distillate has a more subtle odour, flavour and colour than less refined extracts making it suitable where a milder taste or bouquet is preferred. CBD Distillate is suitable for use in vaporiser cartridges, infused products, tinctures, edibles, topical products, capsules and other uses where a mild hemp taste is acceptable.
Distillate is the preferred extract for use in vaporiser cartridges, though due to it’s high CBD levels crystallisation can be a major issue.
GMP NDT CBD Distillate – “THC Free” (No detectable THC)
GMP NDT CBD Distillate is a hemp oil distillate product which has been further processed to have very low levels of THC such that they do not show up on standard testing.
Such product is typically called “NDT CBD Distillate” for “Non detectable THC CBD Distillate” or “THC free distillate”.
While THC levels are below the 0.3% required to meet hemp law compliance, they aren’t typically zero, but rather often 0.1% or so which often won’t show up on testing.
NDT CBD distillate combines the benefits of Distillate (full spectrum of terpene and other entourage compounds) and isolate (very low THC allowing international sale and shipping).
NDT CBD distillate is typically considerably more expensive than both normal distillate and isolate. As an aside, isolate is often cheaper than distillate, because it can be produced from low quality hemp using chemical processing, whereas distillate requires higher quality hemp flower inputs and more skilful processing to produce a premium distillate product without using toxic solvents.
GMP CBD Isolate
GMP CBD Isolate is a white or off-white crystalline powder which is hard and solid at room temperature.
CBD isolate is obtained by further concentrating distillate or oil through chemical processes to remove most impurities.
CBD Distillate typically has CBD content of 99.5% or higher depending on the source material and type of CBD isolation process used.
Popular refinement methods include a combination of distillation and chromatography.
Note that most producers use strong chemical solvents such as Pentane to produce isolate, so it’s a less “natural” product than an extract or distillate. These solvents should be fully removed by competent operators.
GMP CBD isolate should have standardised potency, purity and b free of contaminants such as pesticides, heavy metals, microbes and THC.
Depending on the end use there are various grades of GMP isolate including medical grade API (Active Pharmaceutical Ingredient) and analytics grade, which cost considerably more and have been produced under more rigorous conditions.
CBD isolate typically has a subtle herbal bouquet and flavour. Some very pure products may be almost free of smell and taste.
CBD isolate is ideal for pharmaceutical manufacturing or other uses where pure CBD is required.
Note that pure CBD typically has lower efficacy than a broader spectrum product such as distillate or oil, so may not be the best choice for patients in all cases. As such CBD Isolate is best used when a tasteless, odorless or pure chemical product is required for scientific or regulatory purposes.
GMP Requirements for CBD
GMP Requirements for CBD manufacture are the same as for every other drug, medicine or food supplement.
Good manufacturing practice guidelines establish operating guidelines for manufacturing, testing, and quality assurance to make sure that the finished product is safe for human consumption or use.
It’s often helpful to think of GMP as common sense and good hygiene on steroids.
The basic principles of GMP include:
- Manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
- Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
- Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
- Operators must be trained to carry out and document procedures.
- Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
- Any distribution of products must minimize any risk to their quality.
- A system must be in place for recalling any batch from sale or supply.
- Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
Products that fail to meet mandated GMP requirements may be considered adulterated – regulators, health professionals and consumers cannot be certain that they have been manufactured and handled correctly. (From Wikipedia)
Good manufacturing practices for hemp and CBD are essential safeguard the health of consumers and patients and ensure quality products. They also make good business sense for manufacturers – they reduce errors, waste, losses and allow controlled recall in the event of problems with the product. GMP represents a coming of age for cannabis products – as they move out of basements and garages and into a mainstream health and medical context.
With CBD Legalisation comes Regulation
Now that Pharmaceutical CBD Drugs such as Epidiolex, the FDA has begun to properly regulate hemp and CBD products and manufacturers, and it has already started issuing warning letters to companies not meeting cGMP compliance.
Currently 99% of CBD produced worldwide is done so without reference to GMP standards – often in obviously substandard facilities and processes such as garage labs that carry significant risk to personnel and end patients.
This means that most companies, and most product on the market is non compliant, which carries a major risk for established brands and companies wishing to enter the CBD space.
Sourcing GMP CBD Products
Sourcing GMP Products has been difficult until now because hemp and CBD are in a grey area from a regulatory perspective across much of the world.
In the US in particular, hemp has been protected by the farm bill and related legislation, but CBD was still of uncertain status. The new US farm bill is expected to pass which would place both hemp and hemp derived CBD extracts on clear legal footing for the first time.
Once this occurs, the conditions are right for the development of a GMP CBD industry, though it will take time.
GMP CBD Supply Contracts
Rhizo Sciences is offering supply contracts for GMP CBD hemp Extracts including oil, distillate and isolate to qualified manufacturers.
Due to the overwhelming demand and very new and limited supply of this product we have a long waiting list and stringent qualification requirements for prospective buyers.
We are seeking genuine long term purchasers with demonstrated manufacturing capability, market access, legitimate use, financial capability and business integrity.