Good manufacturing practices
We invest time, money and resources into fostering practices and habits for hemp processing, manufacturing and production. Our commitment to our customers and end users guides our decisions and process design.
For millennia cannabis has been used by cultures therapeutically the world over. Unfortunately, in modern times decade of prohibition and misinformation have stifled scientific research into the medical benefits of cannabis. More recently, thousand of studies have sought to better clarify the therapeutic benefits that cannabis can offer. Cannabinoids such as THC, CBD, CBG and others along with terpenes have been observed to work together potential offering more benefit when consumed in combinations. This effect is know as “The Entourage Effect”.
Plants and plant medicines have natural variability. Because of this variability, standardizing medicines and products to a known potency and purity can be challenging, but it is possible.
Within the industry systems have been developed to tackle the quality challenges and offer quality assurances. These systems have been developed for herbal medicines, foods and pharmaceutical drugs.
These systems include processes like HACCP which has been used previously in the food industry, and Good Manufacturing Practice or GMP. GMP is used in the pharmaceutical, manufacturing and food industries.
Good Manufacturing Practice for Medical Cannabis
GMP, Good Manufacturing Practice is the most recognized standard in the pharmaceutical industry. GMP is the standard for working with compounds, using these standards within the hemp industry must take into account the natural variations of the plant. A complete system from cultivation to final product assembly must be in place if a hemp manufacturer to guarantee quality assurance.
These standards when applied correctly are known as Good Practices.
GCP for Medical Cannabis, Hemp and CBD
All throughout the resource chain we have discovered many areas in which industry practices could be improved above current common practice. Our clients can have the confidence our products have the highest quality and are supplied to the highest standard.
Our quality standards are a core component and bedrock of our safety standards. The safety protocols we have implemented are tied closely to the management practices we implement. Our systems are integral to our final product and reflect international standards.
Through-out our intake, processing and production; multiple rounds of third-party testing gives us a empirical measurements and data points in order to optimize results. The third-party testing also gives us the ability to create a baseline prediction of yield, prevent contamination, and give the cultivator assurance they can trust the process.
Independent third-party testing supplements the implementation of related standards for Clinical Trials (GCP), Drug Distribution (GDP), Pharmaceutical Dispensing (GPP), Laboratory Testing (GLP), and Agricultural Production of Herbal Medicines (GAP) ensure quality is maintained throughout the supply chain from seed to sale.
Good Cannabis Practices Overview
In order to insure of high-quality, high-grade product implementation of GCP must be professionally planned and managed.
Our lead engineers come from the petroleum and aerospace industry and have converted stringent safety standards.
Once genetics have been acquired, the supply chain has 6 main activities:
GAP: growing plants to the point of harvest of whole plant herbal cannabis
GMP: Processing of herbal cannabis, extraction, API & final product manufacture
GLP: Analytical testing of herbal cannabis, extracts, APIS and final product forms
GDP: Distribution of herbal cannabis, extracts, APIS and final product forms
GCP: Clinical trials and clinical practice, including pharmacy dispensing
GSP: Security guidelines covering the whole process – integrated into other guidelines.
Using clones, high yielding hemp genetics can be selected for and grown in climates or facilities optimal for those genetics.
Testing can be done during cultivation to best establish when the plant is ready for harvest. Further steps including drying, curing and processing should be done according to Good Agricultural Practice conditions.
Post-harvest activities where the plant matter (biomass) include trimming, curing and packing. Depending on the desired final product a processing plan can be made. The processing plan can include processing for export, manufacturing assembly, capsulation, palletization, extraction, distillation and isolation among others.
Preliminary processing of biomass extracts during GMP guided processes produce an oil with 50% to 80% cannabinoids. This crude can then be further refined to remove a high percentage of impurities and to further concentrate the desired cannabinoids.
The Active Pharmaceutical Ingredients are consistent, GMP ingredients can then be offered as wholesale products, or further formulated into final product varieties such as topicals, capsules, tablets, tinctures and others.
Cannabis Active Pharmaceutical Ingredients (APIs)
Pelletized Standardized Dried Herbal Cannabis (10-20% cannabinoids)
Cannabis Oil (40-50% cannabinoids)
Winterized Crude (45-55% cannabinoids)
Distillate (80 to 85% cannabinoids)
Second Run Distillate (90 to 98% cannabinoids)
Isolate (99.0% to 99.9% cannabinoids)
Final Product Manufacture
Finalizing the product into sellable form requires it to be tested and packaged into individual containers or doses. Before distribution the product can be individually labeled, packaged and stored to the wholesaler’s specific requirements.
The final step in our services is often distribution. This can include many variables, including: logistics, transport, storage, packaging, labeling and sales.
Distributing the final product can require the same levels of security and control as the processing and product assembly. Especially when product fall into the spectrum of pharmaceutical grade products, special care must be taken, and more testing must be completed.
Quality Systems and Documentation
There’s a saying in the industry: “Documentation or it didn’t happen!”.
The high importance of documentation and testing means a GMP operation need to be planned and implemented by an experienced professional engineer. Good measurement, testing and documentation practices are mandatory to provide a high level of quality control.
Quality Assurance for Pharmaceutical Grade Production
Pharmaceutical and food grade CBD products appropriate for research and consumer goods require the implementation of quality assurance practices. Collectively known as Good Practices, these systems ensure product consistency, quality and safety.