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Building a GMP Facility for Cannabis Extraction and Finished Products
The US market is still operating on a state-by-state basis. Since cannabis is a fairly new market and is not legal nationwide in the US, federal agencies have not yet developed standards. The FDA establishes Good Manufacturing Practice (GMP) regulations for a wide range of products including foods, human and veterinary drugs, vaccines, medical devices, radiation-emitting electronic products, cosmetics, dietary supplements, and tobacco products. Obviously, cannabis can be used in almost all of these categories. Companies under the jurisdiction of the FDA are required to be up to date on the most current regulations, often referred to as cGMP, which stands for Current Good Manufacturing Practices.
Even if the FDA has no guidelines yet for cannabis-related products, some companies are going the extra mile to make sure they are ready and ahead of their competition when regulations are in place. Regulations will be unavoidable in the upcoming years to guarantee the population’s safety. A proactive way to become a pioneer in this industry and to set a higher customer standard from the start can be to follow some of the good practices of regulated industries like the pharmaceutical and drug compounding industries.
What is cGMP?
The FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
For producers who want to export to Europe and Australia, stringent regulations are already in place. Good Manufacturing Practice (GMP) certification is key for medical marijuana companies with international ambitions.
GMP standards are more costly to implement when initially starting a facility, but the access to international markets provides a potentially large increase to the return on investment.
GMP is required for companies that plan on exporting to Australia (TGA-GMP certification) and also to Europe (EU-GMP certification).
While recreational marijuana regulations are still a bit ambiguous, this is not the case for pharmaceutical-quality ingredients for the manufacturers of Active Pharmaceutical Ingredients (API) for medicinal products.
Some applicable regulations
Please note that the information on this page is only provided for educational purposes. The definitions and concepts are oversimplified in order to assist with understanding. If help is needed in this respect, seek the advice of an expert in your particular process and refer to the applicable regulations.