IS YOUR COMPANY cGMP 210/211 COMPLIANT?
A couple of years ago, a friend asked me to teach him how to make cannabidiol (CBD) isolate. A few days later I drove into the country and found him in an actual (and proverbial) barn – dirt floor, tobacco boxes, and threshers from the 1950s. My friend was pouring dirty pentane into a 50L reactor while a cigarette hung out of his mouth. Seriously. This process was acceptable in his eyes. And he’s not the only one.
On the drive back to Raleigh, I realized the real danger wasn’t limited to just the two of us in an explosion perimeter – it was everyone else who would put the resulting products into their bodies. Akin to snow, I hoped nobody ate the yellow isolate, but chances are pretty high they did.
As the industry forged on, hot topics now include cannabinoid production, testing, and compliance. More specifically, Good Manufacturing Practice (GMP) has taken the stage. It does raise an important question: what does cGMP 210/211 even mean, and why does it matter?
First, not all GMP is the same. Good Manufacturing Practice are regulations of the U.S. Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations require manufacturers and processors of drugs, medical devices, cosmetics, and some food proactively ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This protects the consumer from purchasing a product that is not effective or even dangerous.
Manufacturers build operations to follow different guidance documents. 21 CFR 11/110/111/117 addresses electronic records and the manufacturing processes of dietary supplements, cosmetics, and food. For a higher level of compliance and production rigor (more typically in the pharmaceutical sector), firms achieve 210/211 compliance for active pharmaceutical ingredients (API) and finished drug products.
Averix has achieved the rare cGMP 210/211 compliance. And that’s a big deal for many reasons.
- The FDA doesn’t certify your operation as GMP. They publish guidance documents, and you can build an operation that follows the guidance. Third-party outside audits from reputable firms and/or client audits typically verify these documents. If you are manufacturing a drug substance, you should expect an audit visit from FDA.
- Facilities aren’t inherently GMP. It is applied to the products that are produced. It is possible the same operation can manufacture both GMP and non-GMP products with proper segmentation. You can register your facility with the FDA, but that step is a single page form that means nothing in terms of product quality. It simply means you told the FDA “Hey, I exist!”
- The term “GMP compliant” is misused by a whole lot of people. I’ll spare you the industry rant about lack of awareness around manufacturing rigor – simply stated, you’re only GMP if someone else says you are, and the reputation and certifications of that person really, really matter.
It’s not enough to simply be GOOD at manufacturing – you must be GREAT around documentation, process engineering, deviations, and change controls. You must make something that is demonstrated to be safe and effective – and you must repeat this over and over again without change.
We start from a singular belief: regardless of whether your company produces a new drug, makes tasty beverages with CBD, or sells gummies at the local dispensary, consumers deserve to have the highest manufacturing standards possible for cannabinoids.
The short answer to “why GMP matters” is that your customers matter and, more important, consumers matter. Anyone manufacturing cannabis/hemp products are putting drugs into young and old bodies, bodies that often have other conditions, are receiving different medications, and have very different metabolic responses. It’s not good enough to say “I think we’re GMP” or to play the certification game like many play the COA (Certificate of Analysis) game. Compliance shouldn’t be just a goal line or a marketing event – it should be built into the DNA of a company. Sure, true pharmaceutical-grade ingredients cost more, but the difference is measured in pennies per dose. For a typical $50 tincture, the cost differential is only a couple of bucks — and the health differential is invaluable.
It’s worth the time and energy to do things right when others are not. That will make you stand out in an industry that is overcrowded and full of bad actors. Being a leader in an industry that lacks clear guidance is not easy. But educating people about why cGMP 210/211 matters is the first step to legitimizing this industry and standing by the products we produce.
So, aren’t your clients worth it?
Miles Wright
CEO, Averix Bio
A successful business and entrepreneurial leader, Miles Wright has founded five separate companies and served as CEO of two others, creating more than 500 jobs in North Carolina. His previous firms spanned multiple industries, including nanotechnology, real estate, graphic arts, publishing, and software development. For six years he worked to commercialize advanced technology as Executive-in-Residence at North Carolina State University, consulting with a large number of startup and early-stage companies across many disciplines. Miles is also a founding mentor in the Social Innovations Fellows Program at NCSU. In 2014 he was awarded Life Science Executive of the Year for the Research Triangle Park area.