Prepare for marijuana legalization by way of GMP certification

(This is the third part in an on-going series of tips and advice for marijuana and hemp extraction companies. The second part is available here.)

Legalization is coming. Time to lock the doors.

Marijuana and hemp cultivators and manufacturers prepare for competition as legislative changes pave the way for national and global THC and CBD sales by making large investments in technologies like microbial monitoring and airflow analysis (and air lock doors).

The expensive prep work reflects the type of safety protocols required of anyone who makes products that are consumed by the public.

“For this industry to mature, it is imperative that facilities meet the requirements,” said AC Braddock, CEO of Eden Labs, an extraction company in Seattle.

And what’s next is GMP, short for Good Manufacturing Practice, a long series of cleanliness and safety protocols required by all types of manufacturers who make packaged consumer goods, from commercial bread factories to pharmaceutical companies providing high-tech medical treatments and devices.

The rules – often referred to as cGMP, where “c” means “up to date” because the rules change over time – are not cheap or easy.

Companies can expect to spend six-digit amounts on GMP compliance of their facilities – and more to get a credible certification company to verify GMP compliance.

However, the cost of certification is an absolute necessity for any cannabis producer looking to create products in what will later become a large cannabis market.

“If you want a chance in a mainstream market, you have to have it,” said Summer LaForce, director of FSOil, a hemp extraction company in Woodburn, Oregon.

Where should I start?

The acquisition of the GMP certification starts at the end.

This is because the US and international authorities manage different GMP rates depending on the product. First, determine whether you are doing the following:

Each category has a set of GMP guidelines established by the U.S. Food and Drug Administration (for domestic sales). Canada, the European Union, and the World Health Organization (WHO) maintain their own GMP standards, although all are broadly similar.

Marijuana and hemp cultivators who don’t extract or make finished goods are off the hook.

You will want to look at something called “Good Agriculture and Collection Practices” or the “Food Code” set by the WHO and the United Nations.

These standards cover basic sanitary protocols and include things like harvesting, drying, and storing plants for human consumption.

In particular, the FDA does not set GMP regulations for tobacco production. Instead, the agency oversees tobacco and e-cigarette manufacturing through its Tobacco Products Center. How the FDA might approach a legal marijuana industry is an open question for anyone selling vapes or flammable flower products.

The GMP category or categories that a company selects determine the types of standards that its manufacturing process should follow.

“You have to figure out what product you’re making and then work backwards from there,” said Andrew Samann, CEO of Orion GMP Solutions, a pharmaceutical process engineering company in Port Austin, Michigan.

Find an Expert

Once the company has determined which GMP standards to adhere to, it is time to execute.

The process is so daunting that most manufacturers who are new to GMP compliance generally turn to consultants to give them a roadmap.

GMP consultants study the manufacturing and safety protocols required to ensure that products are safe for human consumption. You’re looking for things like:

  • Clean and hygienic production areas.
  • Equipment and work areas with no gaps in which dust or debris could collect.
  • Proper ventilation and airflow.
  • Training procedures for staff.
  • Recording and documentation of where the input materials come from.
  • Unsafe Product Recall Plans.

First, ask for a so-called “gap audit” – an initial overview of gaps in manufacturing processes that need to be fixed before you receive GMP certification. Expect a few thousand dollars for the audit.

“You can get someone to tell you how far you are from declaring yourself GMP compliant. It’s a good first step, ”said Marielle Weintraub, president of the US Hemp Authority, a voluntary self-regulatory agency that certifies hemp extract products like CBD.

From there, the manufacturer has an idea of ​​how much to invest in order to meet GMP standards and ultimately apply for GMP certification. The final tab depends on how closely the facility is already tracking GMP.

“The cost can be very high,” said John Davis, chief technology officer for Entexs, which manufactures cannabis extraction equipment in Diamond Springs, Calif. “It’s one of those things that always seems to cost three times what you think.

“But it is wise of companies to do this. Every customer inquires about cGMP requirements or cGMP products. We’re just preparing for the time you need to meet these standards. “

Records, records, records

A large part of GMP compliance is not the cleanliness of facilities or equipment. GMP is also a set of written procedures for the facility that give employees (and one day government inspectors) a clear roadmap for making clean, hygienic products.

A GMP facility has protocols for accepting submissions. It includes detailed instructions on how to convert these inputs into a finished product.

GMP facilities keep records that allow the entire history of a batch to be tracked, as well as procedures for testing the final products to ensure that they are safe and unadulterated.

“GMP looks like a lot of paperwork that characterizes all processes,” said Samann. “That’s all the stuff that goes in people, right? You’re going to want a very specific plan to do this safely. “

And GMP compliance doesn’t stop as soon as the devices are in working order and all safety guidelines are in place.

A GMP facility also needs a specific quality assurance officer, often more than one. GMP consultants recommend two or more full-time employees who are tasked with monitoring GMP and maintaining the documentation.

“Future Proof”

GMP compliance is daunting for any craft manufacturer who makes products in smaller quantities. But it’s the cost of doing business in a legal, regulated industry.

Brian Anderson, architect and co-founder of Anderson Porter Design, which designs cannabis production facilities in Cambridge, Massachusetts, describes GMP compliance as “future proof”.

“Think of it this way: What does a batch recall cost you? What does the non-compliance cost you? If you spend millions on a plant construction and don’t have GMP certification, you will completely miss out on ever attracting or getting acquired. “

GMP investments could pay off sooner in an industry where many consumers are curious about how cannabis gets to market, Braddock said.

“How something was made, how it was grown, why it was made – this is something cannabis users are really interested in.”

Kristen Nichols can be contacted at [email protected].

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