MJBizMag May-June 2021 - 58

WELLNESS OUTLOOK
right now, but I didn't see any reason
to backtrack on this. It's about people,
my premises and all the processes and
procedures. And to have all those things
done well equals profit. "
COSTS AND HIRING
The cost of setting up and maintaining a
GMP-certified facility depends on its size.
" For every square foot of
manufacturing space we've built, you can
add almost 30% more per square foot if
you're going down the GMP route. It's
a significant investment, " said Michael
Elias, CEO of vertically integrated
marijuana company Common Citizen,
based in Marshall, Michigan.
Experts also noted " indirect costs "
of adopting GMP such as maintenance
and third-party consultants. Finding and
hiring staff familiar with GMP will likely
be more expensive as well.
But the investment is worth it, Elias
believes. " The FDA is coming, " he said of
the U.S. Food and Drug Administration.
" It's really important that our facility
look and feel like those facilities in Big
Pharma and food when it comes to GMP
standards, because they are the gold
standard. "
ASSESS AND VET
When embarking on a GMP
transformation for your business, it's
important to carefully choose where
and how you build it. And unless your
business has high-level staff that's
well-versed in GMP, hiring a GMP
consultant is advisable.
When Holman found an 8,300-squarefoot,
former fish-processing plant in 2018
that had been built to GMP standards, she
thought she had found the ideal location
for The Galley. Pressed for time and eager
to launch, Holman said she gave the
building less scrutiny than it deserved.
" I should have bulldozed that building
and started again, " she said. Instead,
Holman began renovating only to
discover successive repairs-including
an expensive earthquake retrofit-that
totaled almost $1.7 million.
health care, and his co-founders were
familiar with GMP, they hired Orion
GMP Solutions, a third-party consultant
from Rochester, Michigan, to help design
their facility and processes.
Elias noted that while cannabis
executives can draw from U.S. Food and
Drug Administration-approved GMP
guidelines for the pharmaceutical and
food industries, consultants can safely
navigate the vagaries that inevitably come
with interpreting government regulations.
" It's not this detailed, prescribed
Building a GMP facility can cost 30% more.
Photo courtesy of Common Citizen
" My mistake was I should have looked
at this a little more carefully in regard to
what was it really going to take. You get
all these bids for things, but it's always
more expensive. This literally turned out
to be about three times the expense. "
Had she known about the true extent
of the repairs needed, Holman said she
would have done things differently.
" Instead of scrambling to find
someone to help us fix this problem at
the last minute, I would have planned
it out better. I would have had more of
a chance to really look around and say,
'OK, what are the solutions to fixing this
problem?' " Holman recalled.
Once the necessary renovations were
made, she hired consultants to tell her
what she had accomplished toward
establishing GMP in her facility and what
was still needed.
" Don't try to do this yourself. It's
complicated, and you won't think of
everything, " Holman said.
For $2,500, she hired GMP consultants
Trace Trust from San Francisco for help.
" They just came in and said, 'Hey, you
need to look at this, you need to look
at that.' They gave me a lot of food for
thought, and then I decided what we
were and weren't going to do. "
Although Elias, a former healthcare
executive whose resume includes
running a 450-bed facility for advanced
58 Marijuana Business Magazine | May-June 2021
approach to what you do. It's more of a
guideline, " Elias said. " Those consultants
are critical to shaping the interpretation
of those guidelines and fitting them
into a cannabis framework that will
essentially pass certification. "
FOCUS ON PROCESSES
When it comes to GMP, most of what
needs to be done has more to do with
processes than equipment, said Albert
Gutierrez, CEO of MedPharm Holdings,
a cannabis cultivation and manufacturing
company in Denver that produces
products for both the recreational and
medical markets in Colorado. MedPharm
also is conducting federally approved
cannabis research studies with the aim
of creating FDA-approved medicines
that can be used to treat Alzheimer's,
Parkinson's and other conditions.
" What does GMP mean? Do you
have SOPs in place? Have you put this
washing method in place? That's easy to
say. But to do it in practice and actually
have an auditor come out and review all
your processes and say whether or not
you are doing that, that's a whole other
ballgame, " Gutierrez said.
There are hundreds of details when it
comes to setting up GMP standards for
your business, but the biggest category
of steps would fall under " cleanliness, "
Gutierrez said.
For example, workers cannot mix
ingredients using paddles with plastic on
the ends because plastic is porous, making
it an ideal hiding place for bacteria
that can contaminate your products.
MJBizMag May-June 2021

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