THE Q WORD: WHAT DOES QUALITY MEAN AT AVERIX BIO?
Today we’re talking with Will Corbitt, our Vice President of Quality and Compliance. Will is our pharmaceutical quality control and compliance guru with 46+ years in the business. He’s worked for companies large and small, including multinational companies like Burroughs Wellcome, GSK, Pfizer, Novartis, Roche, and Genentech. He knows FDA Quality Systems Regulations, cGMP’s, ISO Quality Systems standards, and ICH guidelines inside and out, and he has hosted many FDA and third-party audits.
At Averix Bio, we talk about “quality” quite a lot. As the head of Quality and Compliance, what does “quality” mean to you?
When we say that we are cGMP compliant, we mean that all of our products have the highest quality standards ”baked in” to all of our processes—from the soil to finished products. These high standards have been part of our DNA from the very beginning. Unlike many in the hemp business, we built our facilities, our procedures, and our business from the ground up to be cGMP compliant at the outset as part of our core mission. This state of compliance makes all of our products consistent, reliable, dependable, and predictable as it relates to meeting our rigorous specifications.
What role do Averix Bio’s farming partners play in your vision of quality?
Averix Bio’s process begins with our Industrial Hemp (IH) Quality Manager, who forms solid relationships with each of our farming partners to make sure they understand and practice Good Agricultural Practices (GAPs). Averix Bio also requires soil testing from each farming partner to ensure no heavy metals, insecticides, fungicides, or pesticides are present. In addition, we have a relationship with a seed source to supply the farmers, which means we always know the genetics of all the IH that we process. Finally, we stay in contact with our farming partners by performing on-site visits throughout the growing season. We have complete knowledge and control of our supply chain, a key component in Total Quality Management (TQM).
What happens when the industrial hemp crop arrives at the Averix Bio campus?
Industrial Hemp that arrives at our Receiving Department is consistently processed the same way each time, and the IH is quarantined until our random sampling procedures are completed. Random samples are tested by an ISO 17025 accredited, third party analytical testing laboratory to confirm it meets Averix Bio’s specifications. If the testing results are within experimental error of the Certificate of Analysis (COA) results supplied by our farming partners, then the hemp will be pulled for production by the first in, first out (FIFO) method, ensuring that all hemp spends the least amount of time in the warehouse.
What sets Averix Bio’s operations apart?
Averix Bio’s production processes, including extraction, distillation of crude oil and distillate, and isolation of CBD, are all carried out using equipment, operations, and processes that have been validated. Averix Bio’s products are then tested by an ISO 17025 accredited, third party analytical testing laboratory to confirm all Averix Bio’s specifications are met before products are shipped. All data is entered into Rymedi’s proprietary blockchain track and trace software solution and any Averix Bio customer can view their data at any time.
We perform ultra-high performance liquid chromatography (UHPLC) on our in-process production samples to continuously verify they are within our process parameters, and our Tetrahydrocannabinol (THC) remediation process ensures compliance by removing the THC to acceptable levels.
Another huge differentiator between Averix Bio and the rest of the extractors—perhaps the largest and most quantifiable—is our pharmaceutical/cGMP experience. Our initial hires have over 125 years of related experience, our consultants that have advised us on cGMP compliance from day one have greater than 80 years of experience, and we have a combined military experience of over 30 years. This all boils down to an immediate and inherent culture of discipline from both cGMP experience and military service.
Daniel Wadsworth is Business Director for North America and EMEAR at Averix Bio.