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Committee Blog: International GxP Considerations When Cultivating Cannabis – Part 1

Published by NCIA’s Facilities Design Committee

As the global cannabis industry continues to expand, the importance of international GxP standards becomes increasingly vital. GxP is an umbrella term used to describe the various forms of compliance/standards available: GMP, GACP, GMCCP (Bedrocan), etc. While GMP is typically associated with the manufacturing of pharmaceuticals and other consumer products, it can also be applied to plant cultivation (GACP). These guidelines were developed by the World Health Organization (WHO) in 2003; they help ensure the quality, safety, and consistency of products, fostering consumer trust and facilitating international trade. In this blog post, we will explore the key considerations and requirements for cultivating cannabis in accordance with international GxP standards, allowing cultivators to meet the stringent regulatory expectations across borders.

GMP vs. GACP: What’s the difference?

First, it is important to explain the difference between GMP and GACP: GMP (Good Manufacturing Practice) is a set of quality management and manufacturing guidelines and regulations that ensure pharmaceutical, food, and medical device products are consistently produced and controlled according to quality standards. It aims to minimize risks involved in production and ensures the safety, efficacy, and quality of the final product. GACP (Good Agricultural and Collection Practices) is a set of guidelines and principles used in the cultivation and harvesting of medicinal and aromatic plants. It ensures that the plants are grown, collected, and processed in a manner that maintains their quality and prevents contamination, ultimately ensuring the safety and effectiveness of herbal products derived from these plants. 

GxP Best Practices for Cannabis Facilities

Generally speaking, GACP applies to the “cultivation zone” and is less expensive to implement; GMP standards should be used in all “post-harvest zones” and is considered pharmaceutical grade. Below you will find a set of considerations and best practices used in most compliant cannabis facilities. 

  • Compliance with Regional Regulations: Before embarking on cannabis cultivation, it is essential to understand and comply with the specific regulations governing cannabis production in a specific region. Different countries have varying laws and requirements surrounding cannabis cultivation/export, including licensing, permitted cultivation methods, quality control, and product labeling. Familiarize yourself with the applicable regulations (in the country you intend to cultivate in and the country you intend to supply) to ensure full compliance with international GxP standards. Then organize a meeting (pre-audit) with your local audit provider (e.g. ASTM) to develop a proper gameplan.
  • Facility Design and Maintenance: A crucial aspect of GxP compliance is having a well-designed cultivation facility that prioritizes cleanliness, efficiency, and product integrity. Considerations include proper airflow and cannabis specific HVACD systems (e.g. InSpire.ag or Ceres GH Solutions), dedicated cultivation and processing areas, appropriate lighting, appropriate drying space, automation and adequate pest control measures. Maintaining a clean and organized facility with strict hygiene protocols is essential for preventing contamination and ensuring the quality of the final cannabis products. Water quality, flexible cultivation integration, and sustainability should be top priority when in the design phase of your project.
  • Crop Management System (CMS): Incorporating an all-inclusive CMS into your agricultural practices brings numerous benefits to crop monitoring and management. Real-time data collection, remote monitoring, disease detection, true seed-to-sale tracking, employee workflow tracking, certificate of growth analysis, predictive analytics, automated irrigation (based on real time plant weight), and historical data analysis collectively enhance a cultivator’s ability to monitor crop progress effectively. By making informed decisions based on accurate data and insights, cultivators can optimize crop growth, increase productivity, and promote sustainable farming practices. Embracing a good CMS (e.g. WeightSense Adapt), while leveraging the power of a Building Management System (BMS) is undoubtedly the best step forward towards advanced compliance, safer product and higher consistency/quality.
  • Seed and Genetics: Selecting high-quality seeds or clones with desirable traits is vital for successful cannabis cultivation. When sourcing genetics internationally, it is crucial to consider the origin and reputation of the supplier. Ensure that the genetics comply with regional regulations and are free from pests, diseases, and genetic abnormalities. Match phenotypes with your specific environment to naturally defend against some of these risks. Proper documentation and traceability of seed sources are essential for GxP compliance and product consistency. In-house tissue culture labs bring a host of complexity to your propagation department although provide true consistency and reduced disease if carried out properly.
  • Cultivation Practices: GxP-compliant cultivation practices focus on ensuring consistency, purity, and traceability (e.g. CMS) throughout the cultivation process. Considerations include standardized cultivation techniques, such as appropriate nutrient management, integrated pest management (IPM), water quality control, and sanitation procedures. Documentation of cultivation activities, such as crop inputs, environmental conditions, and pest management interventions, is essential for traceability and quality control purposes. As an example, under-canopy lighting (e.g. Thrive Agritech) can help reduce pests, disease, and labor input, all while increasing your yield and product quality.
  • Post Harvest Practices: GxP in post-harvest forms the cornerstone of ensuring the quality and safety of agricultural products after harvesting. These practices use a range of vital considerations, including stringent hygiene and sanitation protocols to prevent contamination, comprehensive worker training to uphold proper handling techniques, implementation of effective traceability systems for accountability, meticulous quality control measures for sorting and grading, and the maintenance of optimal storage conditions encompassing temperature and humidity control. The integration of pest and disease management strategies, robust packaging selection, documentation upkeep, and cross-contamination prevention further validate the post-harvest GMP framework. By focusing on these key principles, producers safeguard product integrity, enhance shelf life, and contribute to the overall safety of cannabis in the supply chain.
  • Quality Control and Testing: International GxP standards emphasize robust quality control measures throughout the cultivation process. Implementing comprehensive testing protocols for cannabinoid potency, microbial contaminants, heavy metals, residual solvents, and pesticide residues is crucial. Regularly analyze samples from each batch to ensure compliance with international quality standards and regulatory requirements. Establishing relationships with accredited testing laboratories can aid in obtaining accurate and reliable test results. Consider SAP analysis and run-off testing if you would like to maximize your situational awareness and plant health.
  • Documentation and Record Keeping: Accurate documentation and record-keeping are essential components of GxP compliance. Maintain detailed records of cultivation activities, including seed sourcing, cultivation inputs, environmental conditions, pest management, testing results, and batch-specific information via proper SOP (standard operating procedures) development. These records serve as evidence of adherence to GxP standards and facilitate regulatory inspections, product recalls, and traceability in the event of any issues. Most importantly, they help cultivators maintain a safe and stable facility.
  • Additional Considerations Include: Worker training, regulated plant-tracking system, inventory control, storage conditions, packaging, handling and cross-contamination practice, waste management and continuous improvement. 

In part two of this GxP blog, we explain the matrix between these interlocking subject matters and how/where they relate to GxP based on department (so keep a look out for part two). 

GxP Standards: Bringing It All Together

Cultivating cannabis in accordance with international GxP standards is crucial for ensuring the quality, safety, and consistency of cannabis products across borders. Adhering to regional regulations, designing and maintaining a GxP-compliant facility, selecting high-quality genetics, implementing standardized cultivation practices, conducting rigorous testing, and maintaining comprehensive documentation are all integral to achieving international GxP compliance. And of course, engage a local GxP specialist with experience in the cannabis field to help navigate your team to success. By prioritizing these considerations, cultivators can position themselves for success in the global cannabis market while meeting the requirements of regulatory authorities and ensuring consumer confidence in their products. It’s time to be a part of the solution, and help break the stigma that comes with cannabis cultivation and manufacturing. 

Member Blog: Hemp and Marijuana Genetics – A Closer Look At The Differences

by George Mouratidis, Industrial Hemp Farms

There are many ways to classify cannabis variants, but the most popular distinction is between hemp and marijuana. Although most of us take these classifications for granted, perhaps you’ve wondered if they are really legit? Put another way: are there real genetic and anatomical differences between marijuana and hemp? And, if so, what are they?

The hemp/marijuana classification is still a major debate within the cannabis community. Although up-to-date research suggests there are genetic differences, critics contend these distinctions have much more to do with legality than botany.

To better understand the complexity of the hemp v. marijuana classification, let’s quickly go through a primer on the cannabis genus. Afterward, we’ll take a closer look at the differences often associated with hemp v. marijuana and why these terms have gained such prominence.

The Basics Of Cannabis Distinctions

The first thing we should clear up is that the word “cannabis” is reserved for the plant genus. This means that both hemp and marijuana technically fall under the cannabis label. For many years, botanists have categorized the cannabis genus into the following three groups:

  • Cannabis sativa
  • Cannabis indica
  • Cannabis ruderalis

Of these three, sativa and indica are probably the most familiar to you. Usually, cannabis connoisseurs draw the sativa v. indica distinction to help differentiate the physiological effects of each strain. Sativa-heavy strains are said to be more energizing while indicas are supposedly more sedating.

It’s important to remember, however, that sativas and indicas were first split up due to their flowering patterns and features. Here are just a few of the key distinctions often ascribed to these two cannabis variants:

Indicas

  • Short
  • Fat leaves
  • Fast-growing
  • Enjoys mild climate

Sativas

  • Tall
  • Thin leaves
  • Slow-growing
  • Enjoys a humid climate

Ruderalis is a shrub-like variety of cannabis that evolved in harsh northern environments. Due to its history in regions with little light or warmth, ruderalis strains evolved unique genetics that allows them to flower automatically rather than relying on specific amounts of light.

Cultivators nowadays cross-breed ruderalis strains with indicas, sativas, or hybrids to create what are known as “autoflowering seeds.” These auto varieties are convenient due to their predictable flowering period, but they tend to have fewer cannabinoids than standard sativas or indicas. Most often new cannabis cultivators use auto seeds to gain valuable growing experience.

Hemp v. Marijuana: The Legal Distinction

So, why do we need a hemp v. marijuana distinction on top of all these cannabis varieties? A short answer is that drawing the line between hemp and marijuana helps a lot in the legal department.

You see, hemp is legally defined as a substance containing less than 0.3 percent of the high-inducing compound tetrahydrocannabinol (THC). Marijuana, on the other hand, could have 0.3 percent THC content or above.

Obviously, this makes it a lot easier for legal authorities to categorize what is and what is not legal. As of today, the U.S. legalized hemp at a federal level, but marijuana laws vary by state.

Beyond THC: The Different Uses Of Hemp V. Marijuana

This all doesn’t mean that the hemp v. marijuana distinction was arbitrarily drawn up to help legislators. OK, the 0.3 percent benchmark was pretty arbitrary, however, it’s true that hemp naturally produces less THC than marijuana strains. But there’s more to this story than just THC.

Now that the CBD market has skyrocketed, it’s often hard for us to imagine non-edible uses of hemp. However, for most of human history, hemp has been cultivated strictly for industrial purposes. Indeed, people have used the hemp plant’s fibrous stalks to make clothing and rope for thousands of years. Amazingly, hemp is now showing great potential in a variety of fields including papers, plastics, cosmetics, and even fuel.

Marijuana, on the other hand, has always been associated with recreational and medical use. Growers who cultivated marijuana were always interested in maximizing certain terpene and cannabinoid profiles for their chosen strain.

So, the distinction between industrial hemp and marijuana is still valid and useful as the cannabis industry expands. Growing hemp for industrial purposes is far more interested in quantity rather than quality. Marijuana cultivation, on the other hand, requires a greater degree of care and attention to detail.

Industrial hemp cultivators could often get away with planting their male and female seeds in rather tough environments. Professional marijuana cultivators, on the other hand, need to focus a lot of attention on making their environment hospitable for female seeds.

Of course, there are now many high-CBD hemp cultivators out there using similar marijuana grow methods. With that in mind, it’s still quite useful for cultivators to distinguish between industrial hemp and marijuana to better plan their growth cycle.

Does Hemp Look Different Than Marijuana?

Now we know how hemp and marijuana differ in THC content, growth features, and traditional uses… but do they look different?

To the untrained eye, mature hemp and marijuana might appear to be the same. Indeed, there are many cases of police accidentally arresting truck drivers for “marijuana possession” when they were actually transporting hemp. There are, however, a few key anatomical differences to look out for.

For instance, hemp plants are generally taller than most varieties of marijuana. Remember that many cultivators are interested in hemp’s fibrous stalks, which is why they’ve bred them to grow as tall as possible.

In addition to their height, hemp plants also tend to have thinner fan leaves compared with most strains of marijuana. These hemp leaves also tend to be concentrated at the top of the hemp flower with few leaves further down the stem. Marijuana plants, on the other hand, tend to have more leaves evenly spread throughout their branches.

Looking Into The Genes: Novel Research On Hemp v. Marijuana

After reading the above description, you might understandably conclude that hemp strains might lean more towards the sativa side. After all, sativas are typically associated with tall height and thin leaves.

While this makes logical sense, recent genetic research is changing how we think about the sativa v. indica theory. A team of Canadian researchers recently published a study examining the genetic makeup of over 80 marijuana and about 40 hemp strains. Shockingly, they found that hemp plants have a closer genetic tie to indicas rather than sativas. Most marijuana strains, however, showed a mix of sativa and indica influences.

The scientists concluded that there was enough of a genetic difference between hemp and marijuana strains to warrant the classification. Of course, more research will be necessary to understand these complex hereditary differences.

So, Is The Hemp v. Marijuana Distinction Valid?

While there will likely still be a debate about the hemp v. marijuana distinction, this classification system is popular for good reason. Also, there appears to be a scientific basis for grouping hemp and marijuana into separate genetic categories.

Distinguishing between hemp and marijuana can help consumers make a more informed decision when purchasing hemp flowers, hemp trim, oils, or other products. Plus, with the growing interest in hemp’s industrial uses, it’s important for farmers to separate out strains for industry and those for human consumption.

While it might not be a perfect classification system, “hemp v. marijuana” is still around because it continues to help cultivators and consumers make informed choices.

George Mouratidis is a cannabis writer and freelance contributor to Industrial Hemp Farms, Cannabis Tech, and Highlife Media.

IHF LLC is a Colorado-based, fully licensed & certified hemp farming and wholesale company. IHF wholesales CBD hemp biomass and many different cultivars of clones and seeds. The Company also wholesales CBD distillate, T-Free, Decarboxylated Crude, Isolate and other cannabinoids produced at our extraction facility. One of our primary goals is to make mutually beneficial deals, connections and contacts in the hemp industry.

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