Utilizing GMP Principles to Improve Cannabis Facilities
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The cannabis industry is somewhat notorious for its patchwork of regulations that need to be followed. Not all states will require the same things from cannabis producers and extractors, and the continued federal prohibition of cannabis means there is no single federally approved playbook that can be followed either.
Following the most stringent possible guidelines from this patchwork is not the easiest route, but it is the pathway that is most likely to guarantee compliance with state rules – and with any future guidelines that might come about through further legalization.
In a talk given at Analytical Cannabis’ “The Science of Cannabis Extraction” online symposium last summer, Heather Despres, director of the Patient Focused Certification program at the non-profit Americans for Safe Access, outlined how extractors can use existing frameworks set out in federal law to implement safe practices and future-proof against possible legislative changes.
Good manufacturing practice
Good manufacturing practice (GMP) is enforced by the US Food and Drug Administration (FDA) and is covered in Title 21 of the Code of Federal Regulations. It includes the Federal Food, Drug and Cosmetic Act and other similar acts that relate to pharmaceutical manufacturing – and so can also be broadly applied to cannabis industry actors who want to make sure that their own manufacturing practices are on-par with the pharmaceuticals space.
The principle tenets of GMPs, for any industry, include the implementation of a good quality management system (QMS), the creation of robust standard operating procedures (SOPs), the sourcing of quality raw materials, and processes in place that will allow for the swift identification and investigation of any deviations in product quality.
For a cannabis extractor, examples of following GMPs could look like introducing a regular review and approval of the cannabis materials supplied by vendors and using high-quality packaging and labelling materials that reduce the risk of contamination. There is flexibility in how these GMPs and a good QMS can be implemented, and these practices should also be flexible enough to adapt to newly passed state or federal legislation, or to repair any gaps identified if a defective product is discovered.
“The goal of GMPs is to ensure that drug products possess the identity, strength, quality, and purity that they say they do,” Despres summarized.
Breaking down the Code of Federal Regulations
Within Title 21 of the Code of Federal Regulations (CFR), there are three subsections of particular relevance to cannabis operators who are looking to utilize GMP principles: Parts 314, 111, and 211.
21 CFR Part 314, Applications For FDA Approval To Market A New Drug
Part 314 covers what needs to be done to apply for FDA approval to market a new drug. Given cannabis’ current federal prohibition, it could be argued that this statute is not particularly relevant. But as Depres explained, paying attention to the guidance given in Part 314 can allow cannabis businesses to prepare for what might be needed should the FDA decide to allow more cannabinoid-based drugs to legally enter the market.
“There is a great need for research products such as flowers, concentrate, edibles, and topicals that are consistently produced to the high-quality framework required by the FDA,” Despres said. “Manufacturers who wish to supply these products to research institutes should be prepared to meet the requirements of Section 314.”
The requirements contained in this section cover the processes that must be followed when dealing with drugs with potential for abuse, information for pediatric use, and other requirements on branding and reporting adverse events.
21 CFR Part 111, Current Good Manufacturing Practice For Dietary Supplements
Part 111 the current GMP (cGMP) guidance for dietary supplements. Given the push from some areas of the cannabis sector to get CBD approved as a dietary supplement this section is of particular importance, but it also serves well as a general list of standards to follow in lieu of any official federal guidance for the cannabis industry.
Depending on the scale of the extraction operation – meaning whether your facility is solely extraction-focused or if there is also in-house cultivation/distribution – different sections of Part 111 will be more or less relevant.
“Part 111 is divided into sixteen different subparts which are aimed at helping operators to identify the standards to which they must adhere,” Despres explained. “These subparts are intended to cover all aspects of manufacturing from the physical – planting equipment, utensils, and components – to packaging and labelling through the manufacturing process into distribution.”
21 CFR Part 211, Current Good Manufacturing Practice For Finished Pharmaceuticals
Part 211 is also cGMP guidance, but this time for finished pharmaceutical products.
“There are many similarities and overlap between Parts 111 and 211, and it is up to each individual operation to determine which part makes the most sense for them to follow,” explained Despres, saying this part “may be considered a higher standard, as the requirements for pharmaceutical products differ from those of dietary supplements, particularly with regard to health and safety.”
There are several important differences between both parts. For example, subpart F contains differences in terms of how yield is calculated in production. Subpart J also lists various requirements on records and reporting that a facility would be expected to maintain in order to pass audits or inspections. Cannabis facilities that want to follow these rules would be expected to keep up-to-date SOPs for each process being carried out in the facility, records of employee training, and extensive documentation for each batch run.
Hazard and risk analysis
In addition to following cGMP standards, there are other avenues that cannabis product manufacturers can take to ensure their operations are in good stead. Following the FDA’s food safety standards, hazard analysis critical control point (HACCP), might be good practice for operations dealing in extracts and concentrates.
Similarly, while the Occupational Safety and Health Administration (OHSA) is federally controlled and so are unlikely to inspect a cannabis operation, operators should look to OSHA standards to ensure they are maintaining a safe workplace that protects its employees against workplace hazards.
While the wider cannabis industry may not be federally regulated, hemp-derived CBD is. And already, the FDA has sent dozens of warning letters to various CBD businesses deemed to be violating the various production or marketing provisions outlined under federal law. Non-compliance with state laws can also result in fines, sanctions, or even production licenses being suspended or completely revoked. Product recalls as a result of operational errors or general poor practices can be expensive, and even irreparably damage the reputation of a company.
“We want to continue to legitimize this industry, and the only way to legitimize this is to actually follow rules and regulations. And that’s not always the easiest thing in the world to do, but the costs of non-compliance can be very great,” says Despres.
“As these rules and regulation evolve, one of the things to keep in mind is that while the most stringent requirement is not the easiest one to meet, it is the one that is going to allow you longevity.”
Using third-party auditors who are familiar with state cannabis laws is one way for a producer or manufacturer to ensure that they are staying compliant with best practices. Despres also recommends getting in touch with the local fire department, who can help in making sure the facility is safe from a fire hazard point of view, as well as looking into third-party accreditation programs designed for operators in cannabis manufacturing and extraction.
“State requirements are going to be different to federal requirements until the federal government decides to do something,” Despres said. “But that doesn’t mean that operators shouldn’t be working to become completely compliant with current good manufacturing practices and following what’s listed in the Code of Federal Regulations.”
This article originally appeared in Analytical Cannabis' Advances in Cannabis Extraction and Processing eBook in March 2021.