Tag Archives: risk management

GMPs & Cannabis Manufacturing

By Kathleen May
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Editor’s Note: While CIJ typically omits the word “marijuana” where possible due to antiquated nomenclature and prejudicial connotations, we understand the legal distinction between cannabis containing THC and hemp requires the use of the word when referencing federal government policies and legislative language.


Despite the rapid evolution of the cannabis industry, the assurance of safe manufacturing practices remains unclear.Both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have imposed significant hurdles for cannabis operators to remain on the “right side of the law.” Therefore, manufacturers of both hemp and marijuana products have been left to figure things out on their own, or choose to ignore existing guidance because the lack of federal oversight allows them to do so. Inconsistent regulation on manufacturing, packaging, labeling and testing of cannabis products offers the potential for unsubstantiated, non-scientific and often times blatantly false claims on product safety and efficacy.

Science vs. Law

Hemp and marijuana are both species of the Cannabis family, Cannabaceae. Genetically they are identical but are arbitrarily defined by the presence of delta-9 tetrahydrocannabinol (THC). While science does not differentiate between hemp and marijuana, the law does.

The hemp industry declared a small victory with the passing of the Agricultural Act of 2014 (2014 Farm Bill). Under this bill universities and state agriculture departments were allowed to grow hemp under state law. Additionally, “industrial hemp” was officially defined by establishing the legal limit of THC at 0.3% on a dry weight basis. The Agricultural Improvement Act of 2018 (2018 Farm Bill), under the guidance of the United States Department of Agriculture (USDA), took things a few steps further by authorizing the cultivation of hemp and removed hemp and hemp seeds from the CSA. The bill however provides no language that mandates the safe manufacture of hemp-derived consumer goods. The 2018 version also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act). To the surprise of most, listing cannabidiol (CBD), even hemp-derived, as an ingredient on consumer product labels remains illegal under the bill. Furthermore, CBD product manufacturers are not protected under the current regulations. Since 2015 the FDA has issued warning letters to firms marketing CBD products as dietary supplements and/or foods, and in December 2018, FDA declared it illegal to introduce food containing CBD (or THC) into interstate commerce, regardless if it is derived from hemp. To date, the only FDA approved CBD product is GW Pharmaceutical’s Epidiolex.

Marijuana remains classified as a Schedule I controlled substance under the CSA. Thirty-six (36) states have approved comprehensive, publicly available medical marijuana programs, and now 14 states have approved adult use programs, with New Jersey passing legislation on February 22, 2021. However, the industry has seen minimal movement toward mandating GMP requirements in the marijuana market. Only a handful of medical programs require manufacturers to follow GMP. Furthermore, the requirements are inconsistent between states and the language in the regulations on how to approach GMP implementation is vague and disjointed. This fragmented guidance supports the complexity and difficulty of enforcing a coherent, standardized and reliable approach to safe manufacturing practices.

What is GMP and Why Should You Care?

Good Manufacturing Practices (GMPs) are a system for ensuring that products are consistently manufactured and controlled according to quality standards and regulatory guidelines. The implementation of a GMP compliant program ensures consumer health and safety, allows manufacturers to understand the intended use of their products, allows manufacturers to defend product specifications as being appropriate, considers the risks to vulnerable populations and minimizes overall business risk. In a nutshell, GMP equals product safety and quality, and defines the responsibilities of the manufacturer to ensure consumers are protected from the distribution of unsafe and ineffective products. Currently, the GMP “landscape” in the cannabis space is complicated. The various “flavors” (food, dietary supplements, cosmetics and drugs/devices) of GMP leave many confused and frustrated when making the decision to implement GMP. Confusion is a result of unclear regulatory requirements as well as operators not fully understanding how to classify or designate the end use of their product(s). Implementing an effective GMP program requires proper planning (both short and long term), financial commitment and qualified resources.

Where Should You Start?

As the regulatory landscape continues to evolve and mature in the cannabis space, your business model must consider GMP implementation if you wish to remain successful and sustainable.

Intended Use

Before you can implement GMP you must first understand what GMP regulations apply to the intended use of your product(s). Are you manufacturing food, beverages or dietary supplements? Get acquainted with the FDA Code of Federal Regulations (CFRs) on GMP. 

Conduct a Gap Assessment

A gap assessment allows you to determine your deficiencies in relation to GMP compliance. The assessment should include, but is not limited to facility design, equipment design, supply chain, risk management and employee training.

Develop an Action Plan

Once the gap assessment is complete a comprehensive action plan will be developed to map out the steps required to achieve GMP compliance. The action plan should follow the SMART Goal principles:

  • Specific (simple, well-defined)
  • Measurable (meaningful)
  • Attainable (achievable, agreed upon)
  • Relevant (resource-based, reasonable and realistic)
  • Timely (time-based, defined due dates)

The plan will include prioritized deliverables, due dates and allocated resources in order to strategically plan and execute and complete the required tasks.

Schedule a Mock GMP Inspection

A mock inspection verifies that the action plan was adequately executed. Hire an experienced resource familiar with related GMPs and QMS to conduct the inspection. A successful mock inspection is a perfect litmus test if the end goal is to achieve GMP certification.

Cannabis manufacturers that ignore the obvious progression toward an FDA-like industry will not survive the long game. Those that embrace the momentum and properly plan to mitigate product and business risk – those who demonstrate integrity and are truly in this space to ensure safe, effective and quality products to consumers will come out on top, gain credibility and secure brand recognition.


References:

  • 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
  • 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and the Food Safety Modernization Act (FSMA).
  • 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General.
  • 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
  • 21 CFR Part 700, Subchapter G-Cosmetics.
  • 21 CFR Part 820, Subchapter H-Medical Devices; Quality System Regulation
  • Congressional Research Service, FDA Regulation of Cannabidiol (CBD) Products, June 12, 2019.
  • United States Food and Drug Administration-Warning Letters, Current Content as of 02/19/2021.

Links:

Comparable to Organic: How This California Company Aims to Certify Cannabis

By Aaron G. Biros
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Cannabis that contains more than 0.3% THC is not eligible for USDA organic certification, due to the crop’s Schedule I status. While some hemp farmers are currently on the path to obtain a USDA organic certification, the rest of the cannabis industry is left without that ability.

Growers, producers, manufacturers and dispensaries that utilize the same practices as the national organic program should be able to use that to their advantage in their marketing. Ian Rice, CEO of Envirocann, wants to help cannabis companies tap into that potential with what he likes to call, “comparable to organic.”

Ian Rice, CEO of Envirocann & co-founder of SC Labs

Rice co-founded SC Laboratories in 2010, one of the first cannabis testing labs in the world, and helped develop the cannabis industry’s first testing standards. In 2016, Rice and his partners at SC Labs launched Envirocann, a third-party certification organization, focused on the quality assurance and quality control of cannabis products. Through on-site inspections and lab testing, Envirocann verifies and subsequently certifies that best practices are used to grow and process cannabis, while confirming environmental sustainability and regulatory compliance.

“Our backyard in Santa Cruz and the central coast is the birthplace of the organic movement,” says Rice. California Certified Organic Farms (CCOF), founded in Santa Cruz more than 40 years ago, was one of the first organizations in the early 1990s that helped write the national organic program.

“What we came to realize in the lab testing space and as the cannabis market grew, was that a lot of cannabis companies were making the organic claims on their products,” says Rice. “At the time, only one or two organizations in the cannabis space were making an attempt to qualify best practices or create an organic-type feel of confidence among consumers.” What Rice saw in their lab was not cannabis that could be considered organic: “We saw products being labeled as organic, or with certain claims of best practices, that were regularly failing tests and testing positive for banned chemicals. That really didn’t sit well with us.”

Coastal Sun Farms, Enviroganic-certified

At the time, there was no real pathway to certify cannabis products and qualify best practices. “We met with a few people at the CCOF that were very encouraging for us to adopt the national organic program’s standards for cannabis. We followed their lead in how to adopt the standards and apply a certification, building a vehicle intended to certify cannabis producers.”

Because of their background in lab testing they added the requirement for every crop that gets certified to undergo a site inspection, sampling, as well as a pesticide residue test to confirm no pesticides were used at all during the production cycle. One of their clients is Coastal Sun Farms, a greenhouse and outdoor cannabis producer. “They grow incredible products at a high-level, commercial scale at the Enviroganic standard,” says Rice. “They have been able to prove that organic cannabis is economically viable.”

The Envirocann certification goes a bit beyond the USDA’s organic program in helping their clients with downstream supply chain risk management tools (SCRM). “Because of the rigorous testing of products to get certified and go to market, we are getting way ahead of supply chain or production issues,” says Rice. “That includes greater oversight and transparency, not just for marketing the final product.”

A good example of using SCRM to a client’s advantage is in the extraction business. A common scenario recently in the cannabis market involves flower or trim passing the pesticide tests at the lab. But when that flower makes it down the supply chain to a manufacturer, the extraction process concentrates chemical levels along with cannabinoid levels that might have previously been acceptable for flower. “I’ve witnessed millions and millions of dollars evaporate because flower passed, but the concentrated final product did not,” says Rice. “We’ve introduced a tool to get ahead of that decision-making process, looking beyond just a pass/fail. With our partner labs, we look at the chromatograms in greater detail beyond regulatory requirements, which gives us information on trace levels of chemicals we may be looking for. It’s a really rigorous audit on these sites and it’s all for the benefit of our clients.”

Envirocann has also recently added a processing certification for the manufacturing sector and a retail certification for dispensaries. That retail certification is intended to provide consumers with transparency, truth in labeling and legitimate education. The retail certification includes an assessment and audit of their management plan, which goes into details like procurement and budtender education, as well as basic considerations like energy usage and waste management.

Fog City Farms, Envirocann-certified

While Envirocann has essentially adopted the USDA’s organic program’s set of standards for what qualifies organic producers, which they call “Enviroganic,” they also certify more conventional producers with their “Envirocann” certification. “While these producers might not be considered organic farmers, they use conventional methods of production that are responsible and deserve recognition,” says Rice. “A great example for that tier would be Fog City Farms: They are growing indoor with LED lighting and have multiple levels in their indoor environment to optimize efficiency and minimize their impact with waste and energy usage, including overall considerations for sustainability in their business.”

Looking to the future, Ian Rice is using the term “comparable to organic” very intentionally, preparing for California’s roll out of their own organic cannabis program. The California Department of Food and Agriculture (CDFA) is launching the “OCal Comparable-to-Organic Cannabis Program.” Envirocann is obviously using the same language as the CDFA. That’s because Envirocann aims to be one of the verifying agents under the CDFA’s new program. That program will begin on January 1, 2021.

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Sustainability for the Cannabis Industry: Part I

By Olivia L. Dubreuil, Esq., Brett Giddings
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The cannabis industry is an unusual creature. It is so new and fluid that nothing in its space is yet crystallized. Product types, brand names, generally accepted processes and procedures are all still being invented and tested. Consumer market segments are defining themselves as the progression of legalization advances through the states. Seniors, children, veterans, women, and professionals of all backgrounds are feeling the health and wellness benefits of the flower that is slowly losing the negative stigma inherited from the so-called war on drugs. The potential is enormous. Money is already flooding to the lucky entrepreneurs with enough foresight to work in the space, and corporate business leaders from many other traditional sectors are slowly, but steadily flocking to the market.

This is economically encouraging. A whole new industry that creates new jobs, generates tax revenue and creates wealth. But there is a worrying scenario. In that scenario, traditional cannabis business owners and entrepreneurs are pushed out of the market as corporate competitors enter the game. In that scenario the industry grows faster than its regulatory framework, with little to no voluntary regulations, no sustainability leadership, and the industry’s practices and reputation finish in the gutter. In that scenario, federal and state regulators ramp up indiscriminate bans and phony prohibitions. In that scenario the new cannabis industry exacerbates the world’s social and environmental problems by being non-inclusive, by creating a divide within communities, by adding its own share of pollution, by pushing unhealthy and unsafe products – all for the sake of an easy buck.

That scenario is not a certainty – it does not have to see the light of day. This industry has the potential to be different. It has the unique opportunity to integrate sustainability practices from the start, to create a space where business meets mindfulness, and where corporate profits do not trump consumer health, worker welfare, community engagement or environmental preservation.

Sustainability strategy is the best risk management tool available to the cannabis businesses emerging today that hope to stay relevant in the future. A sustainable cannabis industry is one where women and minorities feel included, where the consumer recognizes and is loyal to brands and labels, where businesses are thriving while having a positive influence on their peers, a positive impact on their community and on the environment, where the race to the top breeds best practices and innovation.

Three levers can push sustainability: the consumer, the industry (and the businesses that comprise it) and the government (local, regional, national and international). Surprisingly, businesses can have a significant influence on all three. Consumers make and shape a market. What will happen when the consumer becomes aware of fossil-fuel (benzene) extraction in the age of climate change, when they request organic flowers that fits their ‘Wholefoods lifestyle’, or when they boycott non-biodegradable packaging? What will happen when a scandal breaks, linked to an avoidable health and safety accident, or when they realize people of color do not have equal opportunity in a cannabis business?

It is preposterous to think, that in this day and age – where information travels at the speed of light, some type of potentially damaging information about a product manufacturing process will not get out at some point or another (in some cases they have). There is absolutely no need to gamble with that. The solution is simple: adopt sustainable practices from the start.

The third lever is the government – we will come back to the second lever later. The cannabis industry, better than any other industry, knows how the government can make or break a business. If the government decides, like they did in Colorado, that in nine months cannabis packaging needs to be resealable and childproof, businesses will have to sit on several weeks worth of sales until they can find new suppliers, they will probably have to rethink their processes, while absorbing the costs of the packaging they had bought in advance. Worse case, they also have marketing and merchandising to rethink. All of that is costly.

However there is good news; government can be channeled, generally speaking, by doing the right thing. If an industry actively demonstrates a desire to do the right thing, and there is not an exaggerated amount of complaints (or accidents), then regulators will leave it alone. Businesses can and should invest as a group into drafting and endorsing generally accepted industry practices and organizing industry self-regulations. Those will guide governments when they draft regulations, but they could also preempt a lot of nonsensical top down rules

The second lever is the most important, and that is the business lever. Cannabis businesses can make or break this industry. Those who believe that the unsustainable practices that worked in the context of an illegal/black/grey market will work in the context of a 21st century legal industry may need a reality check. Those who continue to promote and endorse them are dangerous for the industry because they breed a climate of distrust, and they bring the industry under closer scrutiny. The cannabis industry needs businesses that display exemplary behaviors, think about their impact, and elevate the discussion as well as their peers.

Whether a business is small, large, mature or emerging, developing a strategic response to these challenges can and will create a sustainable business model. Businesses can gain robust competitive advantages over their peers, reap the rewards of having loyal customers, create thriving communities, and foster healthy natural environments by doing the right thing and embedding sustainability within their business decisions.

Tomorrow’s cannabis industry business leaders will be those that chose to be part of the solution, those that understood that sustainability was vital to their business model and took action early on.logo name1


Editor’s Note: Project Polaris is a California non-profit corporation, offering sustainability coaching and guidance to cannabis industry businesses. By becoming a member of Project Polaris, businesses have access to sustainability experts throughout the year, to set, support and carry out cost-effective, meaningful and impactful sustainability solutions.