Table of Contents

Introduction To Cannabis and Its Regulation

For centuries Cannabis has been used for religious, medicinal, therapeutic, recreational, industrial, and many other purposes. However, in the last 150 years, the plant has become a topic of controversial political and social debate. Even after learning about the plant's potential in disease treatment, its adverse effects couldn’t be ignored. And, that’s why US Food and Drug Administration (FDA) has imposed strict regulations on the production of Cannabis and its derived products. It ensures that all drug products are safe and effective for their intended indications.

The federal organization is aware of the marketing of cannabis and its derived products that can violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) and put consumers’ health and safety and risk. Thus, steps are being taken to improve regulatory pathways for the lawful marketing of cannabis and cannabis-derived products.

Cannabis Legalization (Or is it Legalized?)

If you talk about the legalization of Cannabis and its derived products, as of now, 19 states and the District of Columbia have legalized adult use or “recreational” cannabis markets. A further 18 states allow the medicinal use of cannabis containing more than trace amounts of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis. Also, 10 other states only allow the sale of medicinal cannabis with low THC levels (i.e., less than 0.3%).

After the legalization of Cannabis in the states for medicinal and adult recreational uses, regulations and quality assurances were imposed on the production of Cannabis plants. It was to ensure that the produced Cannabis plants contain the federally approved quantity of cannabinoids and are free of any pathogens.

For more information related to the FDA Regulation of Cannabis and its derived products, visit this official site.

This article talks about the current good manufacturing practices for Cannabis processing and the weakness in the quality assurance system.

Current Good Manufacturing Practice For Cannabis Production

Being a federally regulated crop, Cannabis manufacturers need compliance for their production, which shows the crops’ safety for its consumption. Most state regulations validate that companies are required to produce, process, and package cannabis products using “good manufacturing practices.” What are these regulations? Here’s a list of a few important guidelines from the drug and food CGMPs:

Personnel

• Personnel policies to mitigate the risk of physical, biological, or chemical contamination.
• Hygienic practices to prevent microbial contamination from sick or infected personnel.
• Supervisor and quality control accountability.
• Record-keeping requirements

Physical Plants and Grounds

• Sanitation and maintenance equipment.
• Physical plant sanitation requirements and safe handling of cleaning chemicals.
• Designated water supply for production versus hand washing.
• Pest control requirements.

Equipment

• Regular sanitation and maintenance practices and schedules of equipment and utensils.
• Explicit requirements for specifications of equipment and utensils to mitigate safety risks of equipment and utensil use.
• Regular calibration procedures and schedules of equipment and utensils.

Process and Procedures

• Documented standard operating procedures.
• Documented record-keeping practices.
• Documented specifications for equipment, processes, and final products.

Quality Control of Cannabis Production

Cannabis propagation is controlled at each level, ranging from its planting, and production, to harvesting and supplying stages. Here’re quality control checkpoints for operations after the plant has been harvested:

Biomass

• Visual inspection of biomass to check for quality.
• Analytical testing of dried and cured biomass for required metrics and ensuring safety.
• Regular audits of processes and procedures to ensure best practices are being used and followed.

Extraction and Refinement

• Visual and physical inspection of input material to mitigate the risk of contamination.
• Analytical testing of input material for confirmation of product quality and calculation of final output efficiency.
• Visual and physical inspection for quality of extract at crude and refined stages.
• Analytical testing of intermediate and final extract products for quality, calculating efficiency, and final product formulation.
• Regular audits of processes and procedures to ensure best practices are being used and followed.

Final Product and Formulation

• Visual inspection of all ingredients.
• Visual inspection of the finished product.
• Analytical testing of the finished product for required and voluntary testing measures.
• Quality control sampling of product to ensure target quality and effects of the product are met.
• Regular audits of processes and procedures to ensure best practices are being used and followed.

Company Foundation

• Embedding quality control in company culture.
• Creating and maintaining policy, procedure, and training program documents.
• Regularly self-auditing company grounds, operations, and documentation.
• Establishing routine quality control audits completed by a third-party auditor.

Quality Control Testing

Cannabis flowers contain the highest amount of THC, a cannabinoid highly regulated by the federal organization because of its psychoactive properties, which are also extensively used. Thus, Cannabis flowers, concentrated, and infused products are most tested for the following measures:

For Flowers

• The potency of THC and CBD
• Microbial
• Mycotoxin
• Foreign matter
• Moisture content

For Concentrates and Infused Products

• The potency of THC and CBD
• Mycotoxin
• Foreign matter
• Residual solvent

Problems in Cannabis Quality Assurance and Quality control

• Many laboratories falsify test results. They hide the report of high cannabinoid content or cover pesticide use. Thus, this poor enforcement of lab standards are need to be taken care of while auditing the labs for quality assurance.
• Currently, companies self-sample and are expected to adhere to the required sampling methods. This is a major weakness in Cannabis quality control. A system third party, such as a testing lab, is needed to collect samples and analyze them to obtain reliable and credible results.
• Regulatory expertise is insufficient for robust audits at the production, processing, and laboratory levels.
• In order to ensure that manufacturers and laboratories are using best practices and supplying accurate results, regulatory bodies should spot-check the accuracy of final products on retail shelves. There are only a few states that regularly test products directly from retail shelves. Thus, the incorporation of auditing final product testing is also a major requirement of Cannabis Quality control.

How Plant Cell Technology Helps You Producing Cannabis Under Compliance?

Tissue culture is an effective alternative to conventional Cannabis propagation methods. It can be a major key to Cannabis growers to produce crops under compliance. The technique offers a list of advantages over other traditional approaches used in fields. It includes:

• Producing disease-free plants
• Maintaining plants in a small space
• No requirement for a large hall to maintain mother plants
• Producing true-to-type plants or elite plant varieties
• Produce plants on a large scale
• Conserve plant genome
• Only requires a few tissues to grow multiple plants
• Producing plants irrespective of their season
• Producing plants with increased secondary metabolite concentration

To implement such an advanced technique, you need basic knowledge and hands-on experience to get started with the plant.

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