The Crucial Role of GxP in the Cannabis Industry: Ensuring Quality, Safety, and Efficacy

The cannabis industry has experienced remarkable growth in recent years because of increasing legalization and changing public attitudes. As the industry continues to scale, more cannabis plants are being cultivated and processed than ever before to meet corresponding product demand. This volume increase that is occurring to satisfy the needs of the legal market highlights the paramount role that GxP­—the combination of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Cultivation Practices (GCP)—plays in ensuring the quality, safety, and efficacy of cannabis products prior to consumption.

GxP is a recently-coined term referring to the industry best practices that, in the absence of federal oversight and regulations, are considered to be “table stakes” across the cannabis industry when it comes to minimizing the risk of microbial contamination. GxP is comprised of three categories:

• Good Laboratory Practices (GLP): Implementing and adhering to the procedures in GLP guidance, allows cannabis laboratories to ensure data integrity, sample traceability, instrument calibration, personnel training, and quality control measures, thereby enhancing the credibility of data produced within the industry.
• Good Manufacturing Practices (GMP): Compliance with GMP standards helps to minimize the risks of contamination, adulteration, and product variability, safeguarding consumer health and building trust with consumers.
• Good Cultivation Practices (GCP): Guidance utilizing scientific knowledge, innovative technologies, and responsible management strategies to enhance yields and mitigate contamination by pathogens, pesticides, heavy metals, and other undesirable substances, ultimately safeguarding consumer health and satisfaction.

If you play any role in the cannabis cultivation process, you must proactively plan for risk mitigation efforts to improve the quality of your product and maximize crop profit. A robust environmental monitoring plan and quality program will identify gaps in your processes and actionable insights for optimization if it is grounded in GxP and considers the following: minimizing environmental contamination, multipoint testing, pathogen detection, quality indicator testing, and knowing when to engage with experts. Let's take a closer look at each of these.

Minimizing Environmental Contamination

Cannabis cultivation is a complex, agricultural process, and healthy plants can easily be contaminated through its growing environment. For a cultivator, it is imperative that you understand the airflow and irrigation systems in your facility to know where bioburdens may exist. Additionally, good environmental and sanitation standards will go far to help minimize risk of contamination. This can be as simple as using an alcohol wipe to sterilize cultivation tools between plants, enacting personal protective equipment (PPE) fundamentals, and implementing best practices from the US Food and Drug Administration (FDA) Hazard Analysis Critical Control Point (HACCP) procedures.

Multipoint Testing

To maximize yields and passing products, cultivators must identify the likely sources of contamination. Establishing an environmental monitoring program (EMP), with multipoint testing sites throughout the facility will provide the necessary data to aid them in making informed decisions.Tracking and trending the data collected from your EMP can help determine the most likely sources of contamination. With this information, cultivators can use specific strategies to mitigate known risks and improve the overall quality of their grows.

Account for Both Pathogen Detection and Quality Indicator Testing

Monitoring for pathogens is often the driving factor for EMPs, but that information provides cultivators only one part of the puzzle. Testing for quality indicators (coliforms, Enterobacteriaceae, total aerobic, or yeast and mold count) which are often present at various contamination levels, provides the necessary data to pinpoint sources of contamination whether by facility design, environmental input (air flow, water quality, and so on), or personnel. Tracking quality indicator data provides cultivators with the knowledge to make strategic decisions to improve the overall quality of their products and supplements pathogen testing designed to ensure public safety.

When to Engage Experts

Cannabis cultivation is a complicated agricultural process and the development of a comprehensive diagnostic testing plan is a worthwhile investment for both consumer safety and company profitability. The thought of building, or enhancing, a quality control program may seem daunting at first. The good news is, it doesn’t have to be done alone. Cultivators seeking to engage in on-site testing should identify a partner that can understand the nuances of each facility to develop and provide the solutions and services to optimize processes and minimize risk. For those without in-house testing capabilities, compliance laboratories are set-up to monitor for pathogens and other contaminants to deliver timely, accurate results. No matter which direction you choose, the right partner or laboratories will work to ensure crops result in maximum yield of safe product for end-user consumption.

Conclusion

The implementation of GxP in the cannabis industry improves product quality, promotes regulatory compliance, enhances consumer confidence, and strengthens industry reputation. By implementing and upholding these practices, the industry can establish a robust framework that is sustainable and instills confidence in consumers and regulators. Best-in-class diagnostic partners must come alongside the industry to minimize concerns in both the short- and long-term through the application of advanced solutions and services rooted in scientific rigor.

About the Author

Patrick Bird is a Sr. Manager Scientific Affairs at bioMerieux. Direct correspondence to: patrick.bird@biomerieux.com.

How to Cite This Article

Bird, P., The Crucial Role of GxP in the Cannabis Industry: Ensuring Quality, Safety, and Efficacy, Cannabis Science and Technology, 2023, 6(7), 32-34.