GxP – Good Cannabis Practices
As part of our commitment to medical cannabis quality assurance, Pharmaium 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 cannabis 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, standardized 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 Pharmaium we call them Good Cannabis Practices.
GxP for Medical Cannabis, Hemp and CBD
Pharmaium 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 recognized 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
GMP: Good Manufacturing Practice: Herbal Processing
GMP: Good Manufacturing Practice: API Manufacturing
GMP: Good Manufacturing Practice: Final Product Manufacture
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)
Good Cannabis Practices Overview
To ensure quality control and a high grade of product Pharmaium plan to implement GxP Good Cannabis Practices compliant with PIC/S and EU GMP
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.
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. Pharmaium 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.