Standardizing Cannabis with ASTM D37

In 1996 California introduced cannabis for medicinal use, opening the doorway to legalization in the United States. Many other countries and cultures have recognized cannabis for its therapeutic properties. and Now, more than a decade into the twenty-first century, has the US began to accept this notion as well.

Cannabis is now the fastest growing industry in the United States with sales slated for $7 billion, more than a 25% increase from 2016. A poll by Gallup shows that cannabis approval is up to 60% of the American public in 2016 which is 50% higher than 2011. In 2012 Colorado and Washington State became the first states to have recreationally legal cannabis for consumption by those 21 years of age or older.

By 2017 states across the union have recognized cannabis for medicinal use. Currently, 29 states have some form of medicinal cannabis laws in effect with 8 states and the District of Columbia being out right legalized for recreational use.

The federal government still has cannabis listed as an illegal schedule I substance with no oversight by the FDA for regulation. With a serious need emerging for regulation, stakeholders in the budding cannabis industry turned to ASTM International in 2015 for a committee to be formed to create standards. ASTM being an internationally recognized body of professionals that lead the way in creation of standards for industries throughout the world for basically every facet of manufacturing, finally accepted the task in 2017 and created D37 the committee on cannabis. For stakeholders in the industry this was a huge step forward in the recognition of cannabis and its legitimacy as a therapeutic drug with widespread medicinal use.

D37 is the officially recognized committee on cannabis with the inaugural meeting on June 11-12, 2017 in Toronto, Canada. The committee is composed six subcommittees to cover all aspects of manufacture of cannabis which was agreed upon during the meeting to vote and create the committee at ASTM headquarters.

The six subcommittees cover indoor and outdoor horticulture and agriculture, quality management systems, laboratory, processing and handling, security and transportation, and personnel training, assessment, and credentialing. Each subcommittee is chaired by a leader in each respective field.

Those involved in the inaugural meeting all agreed that this is a pivotal point in the industry and the upmost care shall be taken in the development of these standards. Careful consideration will be placed on each and every standard and all stakeholders see this committee as the prime example of what cannabis will be in the next decade.

ASTM has chosen to lead the way in bringing cannabis from the taboo underground into the forefront of horticulture manufacturing. D37 will bring standardization into a medicine that so many already desperately depend on and a medicine that so many more need. ASTM has recognized the flaws in an industry that most have a difficult time acknowledging as a legitimate medicine but understands the more information that is available the more likely it is to be accepted. Cannabis is no longer in basements and closets but controlled in multi-million dollar state of the art greenhouses. This will be the medicine of the 21st century and eliminate the dependence on opioids that are destroying so many lives. Stakeholders of the industry see this as the way in to the future and the help so many need.

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Are you interested in participating in ASTM International D37 Cannabis Standards Committee? Send us an email and we will send you a personal invitation to the committee.

GMP Cannabis simplified into 11 steps

Sometimes it’s best to take a step back, and explain basic concepts of the bigger picture – to take a look at the forest instead of just the trees. Good Manufacturing Practices (GMPs) are complicated systems that assure customer safety. Despite being complicated, you can break them down to a simplified concept of what they are, why they exist, and what it looks like for an operator or technician executing a Standard Operating Procedure (SOP).

What is GMP?

GMP stands for Good Manufacturing Practices. It is also commonly referred to as cGMP, meaning that it is the “current Good Manufacturing Practice” that meets GMP requirements as they are currently regulated. They are the set of regulations that describe all of the operations required to call a drug product, a GMP certified product. Any drug you buy at the pharmacy is produced under GMP conditions.

Why are there GMP regulations?

GMP’s are a way to ensure the public’s safety for manufactured drugs, in order to prevent public health crises. It helps prevent the distribution of adulterated drugs, due to poor manufacturing practices, from reaching consumers that whose health could potentially be harmed.

For example, there was a time before GMPs, where a manufacture could substitute whatever they wanted into their “miracle elixers” that were good for soothing all aches and pains. There was no basis for their efficacy, and the ingredients were completely unregulated. This all changed around 1906 when Upton Sinclair wrote “The Jungle,” where he described the filthy and unsanitary conditions of meat packing plants in Chicago. This completely changed how people thought about how things are manufactured.

What does it mean to operate under Good Manufacturing Practices?

Things have changed since the early 1900’s, and we now have processes in place to make sure that no drug or food substance goes out the door of a factory without having close control over the process. There are many concepts packed into an SOP, and many systems that all work together to make the process work.

So, “from the ground up,” here’s what is looks like when a technician or operator works through a GMP process using their SOP’s. Imagine a technician producing and extract using a Supercritical CO2 process or a Cannabis chef producing an edible with a purified extract.

Obtain the proper and current Standard Operating Procedure (SOP) before starting the job. The SOP will guide the technician through the procedure step-by-step, greatly reducing the chance of operator error.
Thoroughly read through the SOP before starting to make sure that nothing has changed for the procedure, and that the right procedure is being used for the right starting materials.
Follow the instructions exactly, and do not change them or deviate from them.
Work accurately and precisely, paying close attention to the details of each step.
Prevent any contamination or mix-up of materials. Do not have two separate batches of raw materials of in-process materials in the same are without being labeled.
Make sure that no products are mislabeled.
Use equipment that’s been cleaned, calibrated, and is the right tool for the job. All equipment should be well maintained and ready to use. If something is not working, it should be labeled “out of service” until it’s ready for use.
Document your work as it is being done, with initials and dates on the SOP for each step.
Keep your workspace clutter free and clean.
Any documented work may not be destroyed – it can be corrected, but never discard it.
If anything does not go according to the SOP, it must be reported to direct supervisors and the deviation must be documented and analyzed for any risks posed to the end user.

These are the most general guidelines for what GMP looks like in practice. While GMPs are a new concept to the recreational and medical cannabis industry, they’re not new to the pharmaceutical industry. It will take time for the industry to catch up, but it’s not hard to do once a company commits to a culture of quality management systems and cGMPs.

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

A start in the cannabis industry

It’s always a pleasure when I get an email from someone asking how to break into the industry. I can appreciate the feeling – I was once there. I had hustle, and always worked hard, but I didn’t have a clear vision of the end game.

Ultimately, building yourself up in any industry requires experience. You dig into the work and make a name for yourself. There are many ways to get there, but it’s usually a nonlinear process.

I got my start in the industry in an unlikely place – as a Sergeant in the Marine Corps. I realized during my last tour in Iraq that the cannabis industry was in my future. I had my own personal reasons that drove me towards it, but I saw things lining up. I was honorably discharged in 2006, and I immediately got to work on my education in both cannabis and chemistry.

I hadn’t taken a math class in 5 years, and I had no real background in the sciences. Despite that, I started from the bottom and worked my way through all the liberal arts, math, chemistry, and biology courses. I hustled, and my work paid off with the rewards of leading chemistry study groups – I found that teaching is one of the most rewarding things I can do.

I attended the University of Michigan where I studied Biochemistry and spent my free time learning about the physiology of the endocannabinoid system. I wanted to learn everything about how cannabinoids affect the body and their therapeutic potential. I graduated with my B.S. in 2011 and tasted the accomplishment of my hard work. I planned on going through to a PhD program in Biomedical Sciences, but I first wanted to solid foundation in scientific research before jumping into it.

That’s where some luck comes into play. I landed a job in a biochemistry/genetics laboratory at the University of Michigan where I had the best mentors a young scientist could have. I had all the tools of the trade for HPLC, column chromatography, mass-spec, and a project that needed me to use all of them. I was a protein chemist. Every purification started with extractions, and moved on through multiple steps of column chromatography that ended with HPLC purification.

I scaled up processes and thought of myself as the Henry Ford of protein purification… Perhaps it was grandiose to think that way. Nonetheless, it’s where I learned to apply the scientific method on a daily basis, and I where I got my basic understanding for extracting and purifying compounds.

I found that a career in academic science was not for me. It is a surprisingly political atmosphere, and I’m not one for bickering. I was accepted into a PhD program, but dropped out just days before the program started. I knew it wasn’t right for me, and, besides, I had an awesome job in the pharmaceutical industry as a Good Manufacturing Practices Quality Control Chemist. It was there, that I realized Good Manufacturing Practices (GMPs) are the future of the cannabis industry – I finally had my clear vision of the end game.

I always kept myself busy moonlighting in the industry while working as a chemist by day. I put the two together, and found that my best bet was to share information and help other people. HempHacker has become my means of teaching people about different aspects of the industry that aren’t fully covered elsewhere.

Since my last job as a GMP QC Chemist, I’ve been doing GMP Consulting for the Cannabis industry. It aligns all my criteria for a job that’s good for me. I’m able to travel, meet new people, help them with their projects, and do a lot of networking in the industry. It’s also very satisfying to know that my work has a positive impact on the quality of products. It’s a very rewarding job for me.

I’m happy with the way it happened, but I know that I would have different advice for someone starting out now. In my next post, I’ll give my suggestions for people getting their start in the industry. I hope it’ll help people get an advanced start.

GMP Cannabis vs. Extraction content on HempHacker

Last week I sent out a survey to subscribers on the HempHacker email list. The goal was to find what content interests readers the most. The numbers and comments speak for themselves. Overall, everyone loves actionable content, but they would also like to see more blog posts about what’s going on at HempHacker.

The people’s choice is extraction content. If the people will have it, it shall be done. However, I am looking for an experienced writer and cannabis alchemist to join the HempHacker team to write for the crowd. My time is being placed mostly on Good Manufacturing Practices (GMP) consulting lately, and I haven’t been able to focus on extraction content.

I received some very helpful constructive criticism, which I greatly appreciate. It helps me understand how I could do my job better. It’s slightly difficult to scale it for all situations since there are different variables for each system, but I understand the need for specific parameters in doing extractions. I will work to improve this.

64% want more extraction content

New extraction techniques on the market
- Wiped film evaporation
- Short path distillation
Specific parameters for supercritical extractions – i.e. useable parameters
- Amounts to be extracted
- Solvents used
- Temperatures
- Pressures
Solventless extractions
SFE vs BHO comparisons

36% want more GMP Cannabis related content

How to establish GMP systems in your facility
GMP Training
Good Documentation Practices (GDP)
Quality Assurance (QA) and Quality Control (QC) Practices

While I understand the majority want to see more extraction content, GMP consulting pays the bills, and is my primary focus. I really hope that the GMP Cannabis content will also be useful to people doing extractions. It is the definite future of the industry, and I would like to help everyone learn the practices before the FDA regulates the production and processing of cannabis and its extracts.

Thank you to everyone who participated in the survey. Your feedback is very useful to me. As usual, you have an open line of communication to me at andrew@hemphacker.com.

-Andrew

Compliance vs. Good Manufacturing Practices

Just to clarify, there is a difference between Compliance and Good Manufacturing Practices (GMPs). To put it simply, Compliance covers the laws that allow a company to manufacture cannabis and its products, while GMPs provide a framework for how you do it.

Compliance is presently defined as the state by state rules for manufacturing cannabis and cannabis products. It covers the regulations, required transparency, laws, policies, requirements, and standards for manufacturing cannabis. This sets the legal framework for how businesses in their respective states can operate.

Good Manufacturing Practices, on the other hand, are guidelines that come from the Food and Drug Administration and the International Conference on Harmonization. Both provide the requirements for a pharmaceutical manufacturing operation to produce drugs that will be ingested by human beings. They set the operational framework for how to manufacture drugs that are safe for human consumption.

There are also some similarities. Both Compliance and GMPs can have Standard Operating Procedures (SOPs). SOPs are simply the documentation of any process that a company does. They range from simple to complicated. It can be an SOP for sweeping the floors, or an SOP for a 32 step organic chemistry synthesis of tetrahydrocannabinol.

Compliance is without a doubt, the most important first step to establishing your business. Without it, you can face serious legal consequences. Establish your company with a trusted attorney who specializes in compliance, and start manufacturing with peace of mind.

GMPs are the next best step to make your business stand out above the competition – being a GMP Certified facility creates a huge differentiation in your product. With a well defined GMP system in place, you can track improvements to your product over time using the scientific method, ensure consumer safety, and have fully traceable processes. Overall, it’s a win-win adaptation to your business because you improve your processes (and chances to be bought out) and you improve product safety and quality for the consumer (sell more product).

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

Standard Operating Procedures for GMP Cannabis

Standard Operating Procedures (SOPs) are an essential component of Good Manufacturing Practices (GMP). If a process is to be done, it will have an SOP that describes how to do it. SOPs cover topics such as manufacturing, testing, training, management, documentation, lab facilities, cleaning, change control, deviations, and anything else you can think of. It might seem redundant from the outside looking in, but it is a major way for ensuring that pharmaceutical products are produced with consumer safety as the ultimate priority. For the sake of this article, it will mainly focus on manufacturing and testing.

SOPs are meant to be followed exactly as they are written. Improving a manufacturing process is an ongoing goal of GMP. In order to improve a process, procedures must be performed exactly the same way every time the process is performed. The process is treated like an experiment, where all variables are controlled for, as best as possible. Following SOPs is the way of controlling the variables. When a process is repeated, observations of variations will inevitably be made. It’s from observing deviations and variance that changes can be made and improve the process over time.

Improving the process is important, but the primary reason for following SOPs is to ensure that a quality product is manufactured. Following SOPs to the letter is how this is accomplished. This assumes that the SOPs are well written and specify what a quality product is. With a well written SOP that guides an employee step by step, the chance for mistakes that would compromise the quality of the product are reduced.

As mentioned above, there are many different types of SOPs. While documentation, facilities, etc. are important processes to have SOPs for, processes like manufacturing and testing are most pertinent. This is because manufacturing and testing SOPs have a direct impact on product quality.

For a company adopting GMPs into their process, this is the place to start. In both manufacturing and testing, the SOPs will describe exactly how processes are performed. Every piece of equipment used in the manufacturing process has its own SOP associated with it. It clearly describes how to use the equipment, how to service/qualify the equipment, and describes the equipment maintenance schedule. With the operating procedures for every piece of equipment, the processes that follows are clear.

While SOPs describe how to use the equipment, methods are the documents used to describe the execution of manufacturing and testing. A method is a written document, just like an SOP, that guides the manufacturing and testing, step by step. It is the ultimate guide for the process down to the details of manufacturing a drug substance. As an employee works through the method, they initial and date each step as proof that they completed the step exactly as it is written.

With SOPs and methods describing processes, the amount of variance is reduced. Employees will be performing tasks the same way, day to day, instrument to instrument. Reducing the variance improves the product quality, and reduces the chance for a compromised product. With SOPs and good training, there is a great reduction in opportunities for making mistakes. There are nearly no excuses for mistakes, aside from equipment failure, but that’s another story and another SOP.

If you have any comments or questions, please post them in the comments section or email andrew@hemphacker.com.