PUTTING THE GMP
As our industry matures, three letters have begun to hold more and more weight. No, we’re not talking about CBD, CBG or even THC. The three letters that continue to raise eyebrows as much as they raise consumer confidence are GMP or Good Manufacturing Practices—but what do they mean?
In the manufacturing of food, dietary supplements, drugs and cosmetics, manufacturers follow Good Manufacturing Practice (cGMP) guidelines set forth by the FDA and other regulatory bodies to ensure consumer safety. The “c” in “cGMP” represents “current” and it’s the facility’s responsibility to ensure they’re adhering to the FDA’s most current guidelines, as they are continuously changing.
cGMPs are outlined and published by the FDA in the Code of Federal Regulations, but since the FDA has yet to decide how exactly they’re going to regulate CBD, it’s the responsibility of the extractor to voluntarily follow these guidelines and undergo inspection to prove their adherence.
In an industry like ours, where we’re constantly navigating a patchwork of regulations and legal gray areas, the phrase “GMP certified” sometimes gets thrown around by those who might be lacking a real understanding of what it means to comply with Good Manufacturing Practices.
BRINGING COMPLIANCE TO EXTRACTION
GMP covers a variety of areas, including the qualifications of personnel, hygiene, facility conditions, manufacturing batch records, laboratory controls, material control and responsibilities of the quality unit. The level of regulation depends on the type of product being made. It’s the manufacturer’s responsibility to ensure the product is safe for consumer use. A facility that complies with Good Manufacturing Practices is generally a safe choice for consumers, as opposed to a facility that follows their own standards or none at all.
KEEPING PROCESSES IN CHECK
A critical part of conformity to GMP is the documentation of a firm’s processes into standard operating procedures, as well as documentation that demonstrates adherence to those procedures. GMP regulations provide specific direction as to which records are required and how long those records should be kept. Though standard operating procedures provide most of the guidelines for GMP, it’s essential that a company fosters a culture of quality, so that employees prioritize consumer safety instead of exclusively focusing on deadlines and workload.
COMPLIANCE IS CONFIRMED BY INSPECTION
Currently, CBD manufacturers can have their factories and facilities inspected by a third-party agency to determine how their practices stack up to the standards set forth by the FDA. The processes that our Loveland facility uses, from hemp to isolate, have been thoroughly inspected and audited, earning us a certification that confirms we are compliant with cGMP requirements outlined in 21 CFR Part 111 and 117.
SAFETY IS VALUE
By using Mile High Labs CBD ingredients, our customers are not only ensuring they get a pure, compliant and consistent product, but they’re signaling to their consumers that safety and quality are of the utmost importance. The ability to state that your CBD ingredients are produced in a cGMP facility is a powerful marketing tool and can help build consumer confidence in your brand.
SETTING THE STANDARDS HIGHER
While Mile High Labs’ CBD is currently manufactured to meet the GMP standards for both food and dietary supplements, we are continually working to improve our compliance and ensure that our product will continue to meet and exceed regulatory requirements as the industry matures.
We have carefully selected highly qualified individuals from the pharmaceutical industry to develop quality systems and lead the company in ensuring that the product we manufacture is consistent, compliant and of the highest quality. Our Regulatory and Compliance teams are working diligently to establish Mile High Labs as one of the world’s first ISO 9001 certified cannabinoid extractors. We continue to set standards by pursuing and qualifying for the most rigorous quality and safety certifications available.