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Regulations and Business Bottom Line - GMP Does Not Always Equal Expensive

April 1, 2019

As a cannabis business person, do you feel like the cards are stacked against you by the federal, provincial, or state regulatory authorities? Just when you feel like you’ve made the modifications necessary to meet the latest requirements, another set of regulations are imposed, leaving you with little time to adapt. It is an all too familiar scene, and it is frustrating. Like it or not, this is a common reality in an industry with no universal regulations or imposed guidelines. What are actions that manufacturers can undertake to try and limit this feeling of being in an endless rat race short of taking a trip in Doc’s DeLorean? As has been repeated all too often, those who cannot remember the past are condemned to repeat it. Spoiler alert: Good Manufacturing Practices (GMPs) are a large part of the solution.

To the (Relevant) Past We Go:

It’s in our human nature to discount risks and overcompensate after they occur. This is especially true if you look at the history of medicinal drugs and devices.

The first federal legislation that sought to monitor the manufacturing of food and drugs was the Pure Food and Drug Act of 1906 which empowered a bureau that today is known as the Food and Drug Administration (FDA). Over one-quarter of gross domestic product instantly became subject to regulatory authority with its passage. This was during the era of Upton Sinclair’s famous book The Jungle which shed light on the unregulated meat packing industry. At the same time, alcohol, opium, and morphine were common ingredients in adult tonics marketed as syrups that calmed “colicky” babies. This act required labeling of such strong and potentially addictive ingredients. It was an expansion from earlier acts such as the Biologics Control Act of 1902 which was passed after 12 children died from a diphtheria antitoxin that was contaminated with live tetanus bacilli (the tetanus pathogen).

In the 1930s, the first class of drugs that paved the way for the antibiotic revolution were developed, a class called sulphonamides or sulfa drugs. In response to the demand, one company created an elixir using diethylene glycol (DEG) as the carrier or excipient. DEG is toxic to humans at low concentration, is used to manufacture resins and plasticizers, and is present as a humectant for tobacco to maintain moisture content. The result? One hundred and five children died in 15 states over two months. Public outcry led to the passage of the Federal Food Drug and Cosmetics Act (FDCA) of 1938, which is still largely intact today. For the first time, the FDCA required companies to prove their products were safe by conducting basic laboratory studies before being marketed and sold.

A few years later, nearly 300 people died when a sulfa drug was tainted with the sedative phenobarbital leading to the first requirements that look like modern day pharmaceutical GMPs, including the requirement of batch record certification.

In the 1960s, the proliferation of thalidomide to treat morning sickness in European women during their first trimester led to an estimated 10,000 cases of infant deformities. It was initially unknown that the drug was teratogenic (causes abnormalities in an infant or fetus), resulting in deformed arms and legs.

What do all these tragedies have in common? Even the most respected scientists had no idea or reason to believe that the ingredients in these drugs would lead to death or serious abnormalities in the patient population.

What Does This Mean For Your Cannabis Business?

To date, there is no direct proof of anyone dying from commercially manufactured or natural cannabis. Cannabis is one of the safest substances known and its safety profile has been proven over millennia. However, the commercialization of cannabis and its by-products, in an unregulated industry, has introduced elements that allow for potential contamination and danger. A recent article in the peer-reviewed journal BMJ Case Reports described a case of cryptococcal meningitis in a healthy cannabis smoker potentially caused by fungi from cannabis purchased at a legal California dispensary. Compounding the existing stigma and intense scrutiny that our industry faces, nearly 20% of cannabis products failing recent California mandated testing does not bode well for us. It’s easy to see that we are still in the dark ages of cannabis, not too unlike the early and mid 20th century pharmaceuticals.

By looking back at the hard lesson’s pharma was plagued with, we can and should integrate the beneficial foundational concepts from current GMPs into our cannabis operations.

Don’t get me wrong, implementing GMPs are expensive. At the least, it involves hiring a full time Quality Department, conducting validation of your processes, requiring supplier agreements, in-process testing, maintaining meticulous batch records, and tracking of data beyond just seed-to-sale.

Product recalls and rework are also expensive. Paying overtime for employees to stay after hours to run another clean up method because the product did not come out of the rotovap as you had expected, redoing 10,000 labels because someone forgot to double check if they had the right roll, or having to destroy an entire batch because one sample came back positive for a banned pesticide that you are confident you never used. It’s natural to conclude that there is no margin left for a Quality Assurance Department.

There is also an equally small margin for failures. What if you could be guaranteed that your final product would pass final product testing requirements more than 99% of the time? Not only does that include a 99%+ pass rate of your batches, but your process is streamlined in a ‘set it and forget it’ fashion. Your rotovap operates for the same number of minutes within a specific range of temperatures per batch and always gives you the desired concentration of residual solvents. What if you could reduce one or two runs of your wiped film distillation process? What if you could predict problems before they occurred?

If you start doing the math, assessing root causes of production challenges and implementing corrective and preventative actions so the same mistakes (or similar) are not repeated, the choice becomes clear – done strategically, the cost of GMPs can compete with and maybe even reduce the cost of your current operation.

If I were to give this GMP thing a shot, where do I even begin?

The GMP Collective has a team of experts that are ready to assist you and your team. Having successfully assisted many hemp and cannabis companies, we can get your business fully operational and compliant in much less time than it would take to start from scratch.

But, that's not to say many others have been successful without us, and there's no reason why your business can be any different.

Hire someone with previous Quality expertise and make their sole job to understand and document the process.

Issue logbooks for each process and staff and ask them to begin documenting measurements and anomalies, guided by your new Quality person.

Collect and analyze production and cultivation data.

Develop a Mission Statement

Build Cross Functional Teams

Define Job Descriptions and share your Organization Chart with all employees

Promote the right to make a mistake (and document it through a Deviation and Corrective Action Reporting System)

Conduct regular internal audits

One fundamental step at a time, together, all of us can achieve a common goal: To bring innovative, safe, and effective products to the global cannabis market.

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