As a member of the Nectar Health Sciences Board of Directors, I’ve become well versed in the cannabinoid and terpenes marketplace technologies from hemp processing to final product. Drawing on my experiences with Nectar, a privately-owned cannabinoid isolation and extraction company, I thought I’d discuss product quality for medical cannabis and cannabinoids.
Nectar’s experienced scientists and industry experts are dedicated to commercializing a unique and patent-pending cannabinoid isolation technology. The goal is to isolate cannabinoids to >99% purity. In a recent Cannabis Science and Technology article, Miguel Fagundes reviewed quality procedures. He outlined good agricultural and collecting practices (GACP) and good manufacturing practices (GMP). His conclusion?
“Good agricultural and collecting practice (GACP) guidelines and good manufacturing practice (GMP) guidelines each have the simple goals of protecting patients and ensuring that product quality is not compromised through the imposition of standardized practices and procedures in production processes.”
No business should risk jeopardizing product standards or the well-being of downstream consumers, and compliance with GACP and GMP can assist in avoiding such situations.”
Medicinal Cannabis Marketplace Controls
The cannabis marketplace has many moving parts. The work begins in the fields with cultivation and collections of the plants and continues to trimming and drying. GACP guidelines are needed in this part of the process. These guidelines include documentation providing:
- different plant batch numbers
- scientific name of the plants
- relevant information to characterize the material
In addition, GACP guidelines discuss the treatments used to reduce fungal and microbial contamination. Limit the use of chemical treatments for control and plant growth to the list of agents approved in relevant legislation.
The next steps in the process fall under GMP guidelines. This involves initial extraction, isolation and purification, then packaging. This is my area of expertise.
GMP Guideline Processes
There are a number of techniques for initial extraction. They include solvents (liquid propane or butane), ethanol, super critical fluid (SCF) CO2 and specialty formulations from Nectar and others.
Isolation and purification steps can require vacuum, pressure, centrifugation, and other techniques. The packaging step will depend upon the final product use and whether it is a liquid or solid powder.
Throughout, the GMP guidelines require process documentation for reaction, filtration, cake washing, and drying as well as quality parameters of time, particle size, temperature, etc. Basically, any process step that impacts the final product quality must be documented.
Currently, hemp and medical cannabis producers are working towards meeting GMP guidelines for their manufacturing. There are various options and process development to consider. Contact me at P&ID. I’m confident that I can help.