GxP – Good Cannabis Practices
As part of our commitment to medical cannabis quality assurance, Rhizo Sciences has invested heavily in developing best practices for cannabis cultivation, processing, manufacturing and production.
Cannabis is a powerful natural plant medicine with thousands of years of use and study. Decades of prohibition have limited thorough scientific research, but thousands of studies have validated the therapeutic potential of canabis medicines, particularly cannabinoids such as THC, CBD, CBG and others as well as other compounds such as terpenes, and their synergistic action known as The Entourage Effect.
Because of the natural variability of plant medicines, creating consistent, standardised medicines of known potency and purity can be challenging – but not impossible.
These challenges have already been well address through quality assurance systems developed for herbal medicines, foods and pharmaceutical drugs.
These quality systems include processes and standards such as HACCP (commonly used in the food industry) and Good Manufacturing Practice, or GMP (Commonly used in pharmaceuticals, food and other manufacturing).
Good Manufacturing Practice for Medical Cannabis
The best known pharmaceutical manufacturing standard is GMP, or Good Manufacturing Practice. GMP is appropriate when working with standardised pharmaceutical compounds, but to apply these quality standards to cannabis from seed to sale, we need a full system for quality assurance that takes into account the natural variation of the plant and industry practices.
Together these standards are known as Good Practices, or GxP. At Rhizo Sciences we call them Good Cannabis Practices.
GxP for Medical Cannabis, Hemp and CBD
Rhizo Sciences has identified the need to implement Good manufacturing practices and related quality assurance processes throughout the supply chain to ensure that prescribers and patients can be confident in the quality of products we supply. This commitment is evident through the implementation of Good Manufacturing Practice (GMP) based quality assurance and product safety programs, in line with internationally recognised herbal medicine and pharmaceutical manufacturing Guidelines. Quality Systems are also an integral part of our management programs and are closely integrated with herbal medicine, pharmaceutical and Food Safety programs. An independent, third party auditor assesses the quality management system and it’s implementation in a given facility . The feedback received from these audits provides valuable input to our continuous improvement process. Integrated Quality Assurance and GMP Programs give assurance that we are able to provide safe product to our customers and consumers as well as delivering consistently high quality products and services. 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.
Medical Cannabis GxP: Good Practices for Medical Cannabis
- GAP: Good Agricultural Practice: Propagation and Cultivation
- GMP: Good Manufacturing Practice: Processing Herbal Product into Medicines
- GDP: Good Distribution Practice: Sales, Brokerage and Distribution
- GCP: Good Clinical Practice: Prescribing and Clinical Trials
- GLP: Good Laboratory Practice: Clinical Testing and Analytic Testing (Also covered by ISO)
- Rhizo Sciences Quality Statement for Medical Cannabis
Good Cannabis Practices Overview
To ensure quality control and a high grade of product Hikurangi plan to implement GxP Good Cannabis Practices compliant with PIC/S and EU GMP as these are the standards referenced by the New Zealand government.
For a detailed overview of Good Cannabis Production Process workflow click here.
Once genetics have been acquired the 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 GxP.
The plant is grown from selected clones of high yielding medical cannabis genetics, in a controlled, secure facility.
Mature flowering plants are tested to confirm readiness to harvest, before the plants are harvested, dried and prepared for further processing under Good Agricultural Practice (GAP) Conditions.
After harvest, the plant is dried, trimmed and cured for further use before being packed and moved to the next phase of processing. Depending on the final product, this may be further processing for export, manufacture of dried herbal product forms such as dried flower (eg: 1g to 10g packages), or dried herbal capsules, or it may be sent for extraction and further refinement.
Following initial processing of herbal product, active ingredients are extracted under GMP conditions to produce an oil with approximately 50% cannabinoids. This can then be further refined to remove impurities and concentrate cannabinoids.
The Active Pharmaceutical Ingredients are standardised, GMP ingredients that can then be sold as wholesale products, or further formulated into final product forms such as tinctures, tablets, capsules and topical products.
The resultant APIs can be exported and sold to manufacturers, or formulated into final product forms. These APIs are the commodities of the cannabis industry, and are often traded in the 100s, thousands or 10,000s of kg as part of supply and offtake agreements.
API Manufacture and Distribution are governed by specialised areas of GxP.
Cannabis Active Pharmaceutical Ingredients (APIs)
- Granulated Standardised Dried Herbal Cannabis (10-20% cannabinoids)
- Raw Cannabis Oil (40-50% cannabinoids)
- Winterised Cannabis Oil (45-55% cannabinoids)
- Distillate (80 to 85% cannabinoids)
- Double Distillate (90 to 98% cannabinoids)
- Isolated cannabinoids (99.0% to 99.9% cannabinoids)
Final Product Manufacture
The Active Pharmaceutical Ingredients can then be formulated into final product forms to be packed into individual containers or doses (such as bottles of tinctures, tablets, capsules etc). These final product forms can then be labeled, packaged, packed and distributed to wholesalers and retailers.
Distribution of cannabis product requires similar levels of security and quality control to the manufacturing process. Distribution includes storage, transport, logistics and warehousing the product via wholesalers, exporters, distributors and retail outlets (pharmacies), to reach the final patient with a legal medical cannabis or CBD prescription.
Quality Systems and Documentation
There’s a saying in the industry: “Documentation or it didn’t happen!”. There’s no better way to describe the utter importance of documentation in a GMP operation. When documenting data and/or information on controlled records, proper documentation practices must be followed. Rhizo Sciences followed GDP, or Good Documentation Practices, when completing controlled documents.
Quality Assurance for Pharmaceutical Grade Production or Clinical Trials
To develop a pharmaceutical grade product suitable for clinical trials and development of registered therapeutic drugs, we will implement a full suite of Good Manufacturing Practices and related quality assurance systems. Collectively known as Good Practices, or GxP these systems ensure product consistency, quality and safety. GxP looks at all aspects of drug production – from seed to sale. Rhizo Sciences designs and builds GMP manufacturing into the facility, and implement a GMP quality assurance process as part of a managed services agreement to ensure facilities can obtain GMP certification.