CBD oil is now a part of many consumers’ lives, through lifestyle products, food supplements, and even cosmetics. High-quality products are always of great importance, but even more so in hemp products, as the impurities can cause the product to lose effectiveness. The production process is a significant factor in the quality of the overall product. However, high-quality products are a culmination of multiple factors, including:

  1. Purity: To extract CBD from the plants, high-CBD content hemp plants are bred. This means the variety of the hemp plant is essential as there are some plants in which the THC content is higher.
  2. THC content: In most countries, the THC content allowed in CBD products is regulated and must be shown on the label. When considering a high-quality CBD product, it’s essential to look at the title and review the CBD content vs. the THC content.
  3. Independent Analysis: the testing of the CBD product should be completed by a third-party testing laboratory or institution. This third-party analysis validates any internal testing the manufacturer may have met and increases consumer confidence in the product. In the US, manufacturers must have these test results available to the consumer.
  4. Manufacturing Process: the manufacturing process is a decisive factor in determining the quality of the product.

The CBD oil is extracted from the cannabinoid during the manufacturing process to become cannabidiol; this process should leave the CBD oil with the lowest possible THC content. CBD Isolate also contains cannabidiol. However, it is further isolated and purified into crystals during the manufacturing process. Quality assurance and quality control are necessary since this is arguably one of the essential stages in the manufacturing process. These stages should all be validated and well-controlled to limit the number of impurities in the cannabidiol and, subsequently, the final product.

All the components of the quality management system (QMS) within a cannabis production facility – including testing methods, analysis types, and sampling plans – are directed towards quality control and generating a certificate of analysis. This certificate acknowledges the product meets the quality and efficacy standards. While many believe the QMS is only related to process parameters, it involves much more.

The QMS controls the settings of the process equipment, defining the necessary operating ranges, Good Manufacturing Practices such as standard operating procedures and training. It also sets the standards for the manufacturing facility, including the humidity and temperature. The QMS must be implemented, and all quality controls in place. When the product is filed with the correct notified body, strategies such as the risk management strategy can be complicated concisely.

Experts at EMMA International can help create and implement an effective quality management system into a production facility, how to conduct third-party testing or ensure your product is as safe as it could be. Contact them today by phone at 248-987-4497 or by email at info@emmainternational.com.

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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