The safety and effectiveness of a health and wellness product is determined by the level of consistency and control maintained over the manufacturing process. CBD products are no exception. The best CBD companies adhere to what is known as current Good Manufacturing Practices (cGMP). To ensure you’re getting the best CBD product on the market, you’ll want to verify cGMP compliance before making a purchase. Below, we break down the cGMP manufacturing guidelines and explain their role in quality CBD products.
What are cGMP Manufacturing Practices?
At their core, current Good Manufacturing Practices are a set of federal regulations enforced by the FDA to ensure that a manufacturer’s quality system is adequate to consistently manufacture safe and effective products. CGMPs help to assure proper design, monitoring, and control of manufacturing processes and facilities.
According to the FDA, "Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations."
These regulations were put in place to protect the US consumer from ineffective or unsafe products. The cGMP manufacturing requirements have been established for manufacturers of medical devices, food, supplements, animal feed and veterinary drugs, and human drug products. There are separate sections of the Federal Code of Regulations for each of these product classifications, and the cGMPs are prescriptive, not descriptive in nature. In other words, they provide guidelines to industry describing what controls must be achieved but do not explicitly state how a company must implement the controls. Therein lies an important element of cGMP manufacturing regulation; the “Current” aspect. The FDA added the “c” to GMP to recognize the ever evolving state of science and technology known as “Industry Standard” and the agency's expectation that manufacturers will maintain their quality systems to be current with that standard. Current Good Manufacturing Practices are intended to drive continuous improvement.
While there are separate cGMP regulations for the different industries under the FDA’s jurisdiction, each set of regulations focus on the same basic elements. These elements include controls and written procedures encompassing every phase of a product’s lifecycle from the purchase of ingredients and packaging components to finished product distribution and beyond. Examples include:
- Raw materials inspection and testing (QC release prior to use)
- Criteria for approval and monitoring of suppliers (level of control is usually based on criticality of the material being purchased)
- Control and maintenance of documents and records (revision controls and revision history)
- Validation of equipment, processes, equipment cleaning and testing methods (demonstration that equipment, processes, and test methods perform consistently and meet specifications)
- Facility design and environmental controls to ensure cleanliness, prevent microbial growth, and prevent cross contamination of product of ingredients and products
- Employee hygiene and gowning requirements
- Preventive maintenance for facilities and equipment
- Calibration of equipment and test instrumentation
- Employee training and competency evaluation to demonstrate training effectiveness
- Documentation of manufacturing steps and test results in a manner to facilitate investigation of non-conforming product and evidence that each lot was manufactured according to the document process and meets specifications
- Corrective and Preventive Actions, complaint handling, deviations from the documented process and handling of non-conforming product
- Lot tracking (electronic or paper documentation) of raw materials used in each manufacturing lot and tracking of the manufacturing lot to individual customers in the first level of the distribution chain
- QC testing and release of product prior to market release to ensure purity, potency, and effectiveness to include independent 3rd party testing
- Shipping, handling, and storage requirements to protect the product from contamination or degradation
- Mechanism for getting product back from customers and/or communicating with customers if there is an unforeseen problem with released product on the market (Recall)
- Management Review of product and process quality trends in order to implement continuous improvement and identify potential safety hazards or quality issues
The FDA expects that the elements listed above will be fully implemented to protect us all from companies that cut corners and take risks to inflate profits.
Why is cGMP Manufacturing Important for CBD?
Due to its sudden federal legalization, the CBD industry remains largely unregulated and many states are on entirely different pages, legally speaking. The cultivation and processing of hemp as an ingredient in CBD products is regulated by the US Department of Agriculture. In turn, the USDA has delegated control of the hemp industry to the individual state’s agriculture departments. Meanwhile, the FDA remains undecided on the standards and regulations for CBD consumer products, including whether these products should be treated as a food or a supplement, dosage suggestions, labeling requirements, and more.
By self-imposed adherence to cGMP manufacturing standards, CBD companies reassure their customers that their products are high-quality, safe, and effective. Compliance with cGMP requirements identifies the best CBD companies and filters out fly-by-night CBD companies who do not have the experience or the ability to deliver on these stringent requirements. Additionally, by following cGMP regulations now, CBD companies will be prepared when the FDA does declare nation-wide CBD consumer product standards.
Most importantly, following cGMP standards ensures consistently effective and safe CBD products. Redeem encourages all CBD companies to follow our lead by putting customer safety first through the implementation of a quality system consistent with cGMP manufacturing guidelines. Our CBD tinctures, CBD creams, or CBD for dogs and cats are crafted under controlled conditions to exacting specifications that ensure our products meet the highest standard of purity, effectiveness, and safety.
Easier said than done!
Anyone can read the regulations, but what does it take to effectively implement them? Redeem was started by pharmaceutical and medical device industry professionals with over 60 years of experience implementing cGMPs in a practical, effective manner. In fact, our parent company is a FDA registered and inspected medical device establishment that also maintains ISO13485 certification. In short, we know how to put the “cGMP” in “CBD,” and we do it every day.
At Redeem Therapeutics, we adhere to cGMP manufacturing for all of our products. Additionally, we provide test results from an ISO170265 certified third party laboratory to further guarantee quality and deliver transparency for each and every batch. We believe that the best CBD products require truth, consistency, and balance. Check out our safe and effective CBD products today.