Cannabis Product Manufacturing & Quality Control
The burgeoning cannabis industry has an unprecedented and critical need for effective quality control testing. This is abundantly clear to anyone involved in the industry, as well as to consumers. The U.S. Food and Drug Administration’s (FDA) June 2019 public hearing on cannabidiol (CBD) included 10 hours of professionals speaking on the substance, and quality and safety were again emphasized. Writing for Analytical Cannabis magazine, Alexander Beadle noted:
The first hearing speaker of the day Peter Pitts, the president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, made this point in his speech before the FDA panel:
“The absence to date of advanced regulatory thinking relative to CBD has resulted in a maelstrom of false claims and shoddy quality standards.” He also called out some current CBD marketing campaigns for being “aggressive and misleading” with the claims being made about their products.
“It’s time for the proponents of CBD, including many highly vocal patients, physicians, pharmacists, manufacturers and distributors, to become part of the solution. Quality must always trump corporate convenience.”
Later on in the hearing, a number of stakeholders reportedly also brought forth laboratory evidence showing bottles of CBD oil claiming to contain 300 mg of CBD that in actuality contained far less, or in some cases no CBD at all. Speakers urged the FDA to do more to regulate these “junk products” out of the CBD market by introducing quality assurance requirements. Dietary supplement lobby groups made statements in support of further regulating the CBD industry, saying that it was unfair of the FDA to continue along this path of allowing an underregulated CBD market to compete with the much more tightly regulated dietary supplement market.
The situation is critical, and that applies to all cannabis-related products. Fraudulent representations of potency are reason enough to require a high level of good manufacturing practice (GMP) quality testing, but the safety of the public with regard to a substance aimed at ingestion or topical usage is of the highest possible importance. For these reasons, labs are springing up in cannabis-legal states and countries, and existing labs are extending services into this area.
Cannabis quality testing, like cannabis itself, straddles two main areas: recreational and medical. Accordingly, analytical approaches tend to come from food testing, environmental testing, and nutraceutical research, as well as full-on pharmaceutical good manufacturing practice (GMP).
CannaQA for Quality Control
The LabLynx CannaQA solution supports any level of quality assurance you choose, from simple unique sample IDs and barcode labels to track-and-trace compliance and full pharmaceutical GMP. Select our Corrective and Preventive Action (CAPA) module, store and manage your quality management system (QMS) documents and standard operating procedures (SOPs) and manual, conduct stability studies, be immediately notified of out-of-specification results, and much more, ensuring world-class compliance and quality.
See the CannaQA Pricing page for more about CannaQA’s competitive, transparent pricing, as well as pricing examples.