Why Does GMP Compliance Matter to the CBD Industry?
September 01, 20225 min read
Why Does GMP Compliance Matter to the CBD Industry?
Low-quality and unregulated CBD products may be ineffective or harmful to the user. The industry needs to comply with legislative laws such as GMP regarding production to ensure that CBD products are of high quality. This article looks into GMP and why compliance matters to the CBD industry.
The safety of manufactured products is paramount to ensure that the consumer receives and uses a huge quality product that will not harm. Some companies make low-quality products or use manufacturing processes and ingredients that can be harmful or ineffective to the consumer. Governments set compliance laws and standards such as GMP to regulate production. The CBD industry has to comply with the GMP standards. Manufacturers that do not comply with GMP standards have to face the consequences. This article looks at GMP, its importance in product manufacturing, and how it works. It also discusses why GMP compliance matters to the CBD industry.
What is GMP?
Good Manufacturing Practice, GMP is a system to ensure that products are manufactured according to quality standards. Gouveia et al. (2015) suggested that this system is controlled by regulatory authorities such as the United States Food and Drug Administration (FDA) and World Health Organization (WHO) to reduce risks that are involved in the production that may not be eliminated through testing of the final product.
How Does GMP Work?
The GMP system examines and covers aspects of manufacturing from the raw materials, equipment used, production, packaging, and labeling. This reduces any risks that may harm the consumer and affect the company. Gouveia et al. (2015)proved that GMP has guidelines that ensure the following areas are up to standard:
This ensures that the end product fits the intended purpose and does not harm the consumer. This is done by implementing the set quality assurance, control, and risk management guidelines.
All equipment used should be designed, placed, and maintained for its intended function. Equipment found with defects should be removed from the premises or clearly labeled as defective.
All personnel involved must be trained and qualified for the work for GMP compliance. Personnel should also undergo Continuous training relevant to their work. Supervisors should also allocate responsibilities to each person to ensure consistency and good workflow.
Sanitation and Hygiene
Potential causes and sources of contamination are identified and eliminated to ensure the safety of the end products. Areas that can cause contamination may include the personnel, raw materials used, premises, method, and equipment. High standards of sanitation and hygiene are important in all processes of manufacturing.
The materials used should be stored properly, correctly, and of high quality.
Validation and Qualification
Important steps in manufacturing should be checked and verified to maintain high-quality production. However, if the quality of systems, raw materials, and equipment is validated to be fit for use, the manufacturing processes will produce high-quality products.
Manufacturing companies should have a complaint system that is GMP compliant. This will mean that every complaint raised should have a ready solution.
Building and Facilities
The production facilities should be in an environment suitable for operation and free from contamination of raw materials and end products. It should be designed to minimize errors and be easy to maintain.
Accurately documented and kept records, in compliance with GMP, ensure that manufacturing processes and changes are tracked. Record keeping should be done, approved, dated, and signed by the appropriate personnel.
Inspections and Quality Audits
Regular inspections ensure that GMP regulations are implemented and followed. quality audits help the industry assess the quality systems set and comply with the GMP standards.
The CBD Industry
Cannabis products are increasing in the market. Cannabis sativa plants contain compounds or cannabinoids extracted and used for pharmaceutical, dietary and recreational benefits. The second most known compound, Cannabidiol or CBD, is specifically produced and marketed because it does not make one high.
Hemp-derived CBD is approved for use in different countries for medical and recreational purposes. The health and wellness industry produces and advertises CBD for various benefits. One must be careful to check for high-quality products with a compliance certificate and many options. Companies use a third-party lab to ensure that the products are of high quality and that every production process complies with the GMP regulations.
How Is CBD Extracted
Most industries grow or source organic hemp from farms. After harvesting, the plant is left to dry to extract CBD from the buds, flowers, or stalk. Citti et al. (2019)suggested that extraction processes vary with companies, such as carbon dioxide and ethanol extraction. CBD products are available in vapes, edibles, creams, lotions, and oils. These are produced in different potencies and types depending on the extraction method. Potencies vary from high to concentrate. Depending on the extraction method, types of CBD products are full spectrum, broad spectrum, and isolate CBD.
Why GMP Compliance is Important in the CBD industry
The end product and benefits of the CBD product depend on the quality of hemp grown, the production method, and the extraction of the CBD. These processes can affect the end product as discussed:
Growing of Hemp
Companies must use high-quality organic hemp grown in suitable conditions. Mead (2019)stated that contamination from heavy metals, fertilizers, pesticides, and other environmental hazards could affect the end product.
Manufactures should store the harvested plants in an area that maintains the compounds of the cannabis. Decarboxylation of the plant can degrade cannabinoids.
Extraction of CBD
Extraction processes used should be of high quality to ensure that the end product is not contaminated or unwanted compounds are not removed. Gibbs et al. (2019) revealed that some extraction methods might produce CBD with impurities needing different purification methods.
Labeling of CBD Products
Proper labeling of CBD products is kept in check to ensure that the consumer does not end up with an unwanted product. This is why the CBD industry must comply with GMP regulations.
Importance of GMP Regulations
GMP regulates all aspects that influence the safety of the end product. CBD companies that comply with the set standards ensure they have quality products, customer satisfaction, profitable sales an increase and follow legislative orders. Audits help maintain and improve the performance of different systems in manufacturing CBD. A company that complies with the GMP standards promotes accountability and boosts the confidence of its customers in its products.
CBD product use and production are on the rise. With no set regulations, companies might make products that can be ineffective to the user. GMP laws are set to ensure that products are safe and high-quality and will benefit the consumer and company. The CBD industry needs to ensure that all production levels are audited and compliant with the GMP laws. This will boost consumer confidence and satisfaction with the products, and companies will have good sales with good customer reviews. Legislation compliance is beneficial to the industry and consumers.
Citti, C., Linciano, P., Forni, F., Vandelli, M. A., Gigli, G., Laganà, A., & Cannazza, G. (2019). Analysis Of Impurities Of Cannabidiol From Hemp. Isolation, Characterization, And Synthesis Of Cannabidibutol, The Novel Cannabidiol Butyl Analog. Journal Of Pharmaceutical And Biomedical Analysis, 175, 112752.
Gibbs, B., Yates, D. A., & Liebling, J. (2019). CBD In The UK. London, UK: Centre For Medicinal Cannabis.
Gouveia, B. G., Rijo, P., Gonçalo, T. S., & Reis, C. P. (2015). Good Manufacturing Practices For Medicinal Products For Human Use. Journal Of Pharmacy & Bioallied Sciences, 7(2), 87.
Mead, A. (2019). Legal And Regulatory Issues Governing Cannabis And Cannabis-Derived Products In The United States. Frontiers In Plant Science, 10, 697.