Last month an article in the Motley Fool highlighted the newly acquired EU GMP certification for Aurora Cannabis. With exportation of cannabis to European Union becoming increasingly popular, more LP’s are seeking to acquire this ceritification to expand beyond the Canadian market.

Orion GMP Solutions is one of the leading GMP compliance firms helping the cannabis industry go international. If your company is interested in EU GMP compliance or becoming one of the first companies in the US to be GMP compliant contact us at info@oriongmp.com. We offer free consultations to help you work towards international compliance or to simply adhere to your state and local guidelines. GMP compliance is complex and Orion GMP Solutions is here to help you every step of the way.

When taking into consideration that tobacco, a combustible product, is regulated by the Center for Tobacco Products housed within the FDA, it becomes apparent that FDA Good Manufacturing Practices and regulations can serve as a wonderful template when looking to establish rigorous standards for cannabis safety and protection against adulterating compounds and materials. 

It is easy to become overwhelmed with the idea of working with cannabis in a production environment.  It can lose its smell easily, it can smell weird after curing, and can even visibly show signs of mold.  Establishing procedures with emphasis on cannabis safety principals is not an easy task.  Fortunately, upon temporarily disregarding unique characteristics of cannabis, what remains is what makes cannabis similar to other agricultural goods and commodities.  This is where established solutions and guidelines for production, manufacturing, and regulating of various products can be of use.  

This article presents a broad overview of shelf stability, challenges in producing unadulterated shelf stable cannabis, and techniques utilized in modern food microbiology that will also be utilized within the cannabis industrial space for internal monitoring of critical control points and regulatory screening for biological adulteration.  

Introduction.

For safe consumption purposes, cannabis extracts that are used as stand-alone products and infused into edible products can be considered a food additive or dietary supplement. Placing cannabis into the same space as dietary supplements or nutraceuticals has many advantages because regulations for safe dietary supplements, functional food additives, and “OTCs” are already established by the FDA.  When taking into consideration that tobacco, a combustible product, is regulated by the Center for Tobacco Products housed within the FDA, it becomes apparent that FDA Good Manufacturing Practices and regulations can serve as a wonderful template when looking to establish rigorous standards for cannabis safety and protection against adulterating compounds and materials. 

Food Safety in Modern Times. 

The advent of molecular biology did more than just provide a foundation for the booming biotechnology industry.  It revolutionized the discovery of adulterating microbial species traditionally identified by lengthy plating and counting methods and protocols.  Food microbiology is the scientific study of microorganisms, both in food and used to produce food.  This includes microorganisms that contaminate food.  Food safety is a major focus of food microbiology and these principles are used to produce unadulterated shelf stable food items and agricultural commodities. Cannabis safety is a subset of food safety.

Shelf Stability – HACCP.  

The formal definition of shelf stability pertains to preserved food which is able to be stored at room temperature for long periods of time.  From a manufacturing viewpoint, shelf stability can be seen as a measure of control over the production environment of a product.  It can also be seen as a result of adherence to that food’s established production requirements by a regulating body, such as, in the case of juice where a 5-log reduction of pertinent pathogenic bacteria is mandated by the FDA.  Regulatory guidance for producing shelf stable food items for the public are available on agency websites.

Hazard Analysis and Critical Control Point (HACCP), is a program that evaluates risks of product adulteration.  HACCP addresses biological adulteration (and much more), the FDA currently defines what is “adulterated,” and then the FDA establishes guidelines detailing how to produce a shelf stable product that is not adulterated.  We even see states, such as California, utilizing the terminology “Critical Control Points,” in the newly issued emergency regulations (DPH-17-010E section 40258 – Preventative Controls, page 57 of 97).

In summary, regulatory guidelines are widespread and applicable in all food manufacturing and dietary supplement processes, while HACCP programs are customized to each individual facility or manufacturing plant.  Cannabis producers that are serious about producing high quality GMP cannabis should have a HACCP plan tailored to their production facility with keen focus on cannabis safety. Focusing on cannabis safety when producing shelf stable products will result in consistent, high quality GMP Cannabis products.

Challenges of Producing Shelf Stable Cannabis Products. 

One challenge presented in producing shelf stable GMP cannabis, is that we have established methods for determining spoilage in cannabis, but, methods for producing compliant product are still not widely spread or commonly known.  When considering the multitude of methods used to screen cannabis, microbial standards seem artificially stringent and difficult to achieve.  Some of these methods of identifying microbial species target species that may or may not be present in high concentration, alive, or excreting a toxin that spoils the product.  To make the matter of producing compliant cannabis even more tricky, most methods for decreasing the microbial load on harvested agricultural goods tend to alter the appearance in some form.  While this is acceptable when intending to further process the raw material, cannabis flower producers, specifically boutique flower producers, are under pressure to maintain the beauty of the flower while protecting the flower from adulterants.

Testing Methods for Process Improvement.

There are a myriad of methods for isolating, enumerating, or detecting spoilage microorganisms, but the rationale for considering a batch of a product to be adulterated is still under review and fluctuating.  This leaves the burden of additional due diligence on cannabis producers that most agricultural commodity producers do not face.  Cannabis producers must establish internal standards of quality for their product that meet or hopefully exceed the standards set by regulating bodies while industrial methods for production are still being established and are not widely distributed or accessible.  This is challenging, because food microbiology and food science is not a commonly studied discipline for growers of agricultural commodities. New, rapid, and “consumer friendly” DNA-based technology is a boon to those interested in food safety from biological adulterating microbial species and establishing internal monitoring of critical control points.  It can, however, be tough to interpret these results and determine instances of spoilage, especially when considering the cannabis industry is still laying its regulatory foundation.  

Variance in cannabis testing lab methodology and results can present even more questions when seeking to improve processes.  Interpretation of microbial testing results must first begin with determination of the method utilized to produce the result.  DNA, RNA, protein, and colony enumeration methods all have differing implications, pros, and cons.  The same can be stated for different analytical chemistry instruments and methods.  These attributes must be considered when seeking to improve internal processes.  Regulated cannabis testing laboratory methods of medical and recreational cannabis screening are being standardized and variance between results and labs is being improved, therefore, being cognizant of testing methodology is especially prudent. 

Conclusion.

Cannabis producers may feel that they are being given an impossible task, that becoming compliant with microbial testing standards is challenging and unfair.  Microbial standards are necessary, but cannabis producers, manufacturers, and regulators should expect this task to be easier said than done.  Overcoming microbial spoilage requires understanding of food microbiology, food processing, the ability to identify critical control points, and establishing methods for monitoring these points.  Increasing the safety and quality of products requires adherence to validated processes and GMPs. 

Contact Us. 

Orion GMP Solutions is a Pharmaceutical Process Engineering firm based out of Denver Colorado. We specialize in the implementation and auditing of GMP Cannabis Manufacturers to assist them in reaching international markets. If you would like to get more information, please send us an email at info@oriongmp.com

This content was written and supported by Orion GMP Solutions