Good Manufacturing Practices, or GMP, are a systematic way of ensuring that products — from food to supplements to pharmaceuticals — are produced consistently according to established quality control standards. Essentially, GMP ensures a universal minimum standard of quality to protect consumers.
For the sake of this article, we’ll focus on GMP in two major sectors. In Europe, there’s a significant medical cannabis industry percolating. In the U.S., 35 of 50 states have medical cannabis programs. Fourteen states (plus D.C.) have recreational programs — all with different regulations.
The World Health Organization (WHO) version of GMP is used by regulators in many developing countries around the globe. The European Union’s EU-GMP and the FDA-GMP used by the United States Food and Drug Administration are seen as equivalent standards. These are both relatively similar to the WHO guidelines. In March 2017, the United States and the European Union signed the Mutual Recognition Agreement. This Agreement enables the FDA and EU drug agencies to rely on one another’s GMP certifications. This saves the EU and U.S. time and money by circumventing duplicate inspections.
The way cannabis is controlled should be no different than any medical product in the EU or the U.S. Previously — because GMP is a federally controlled aspect of trade — the United Nations’ and the United States’ classifications of cannabis prevented the development of any sorts of standardized good manufacturing procedures for quality control in the EU or U.S.
Recently, the UN voted to change the 1971 Narcotics Act. They officially accepted the science behind treating cannabis as a medicine with therapeutic qualities. Hopefully, the new U.S. Congress will realize what most of their constituents already know. Cannabis is a medicine that helps people with a wide variety of issues traditional pharmaceuticals have failed to safely address.
Regardless of the reasons GMP aren’t currently being utilized for cannabis, GMP standards will undoubtedly be required eventually for medical cannabis in the EU and the U.S. Individuals seeking to enter this industry should be aware and take necessary steps to ensure products meet these requirements.
Pharmaceutical, Food, or Dietary Supplement?
How cannabis-based products will be classified — and thus what regulations they’ll fall within — has become the big question. This is especially true in the absence of clear federal guidance and regulations on both sides of the pond.
There are different GMP regulations for medical products, food products, and supplements. Pharmaceutical GMP standards are extremely high and require products to conform to a specific standard deviation. The equipment used, including air cleaning technology, is efficacious but very expensive.
GMP for food products is much different, requiring a much lower standard of reporting and overall quality of equipment used. The higher costs and standards of equipment and reporting get passed onto consumers to conform to these standards.
For dietary supplements and nutraceuticals, GMP standards were previously a grey area. However, now GMP standards — especially in the EU — require manufacturers to very clearly identify the purity, quality, strength, and composition of their ingredients.
It is less a question if GMP must be conformed to in the future. It’s a question of what level of GMP are currently in play for a product-maker. Whether a company follows the GMPs for pharmaceuticals, foods, or supplements in the future will be determined by specific factors. These factors include the product claim and whether or not the company in question produces a raw material to be used as an ingredient or a finished product. In any case, cannabis patients and consumers will appreciate the GMP seal of approval, and countries will require it.
The cultivation of cannabis will be guided by Good Agricultural and Collections Practices, GACP, which the WHO has designated for growing medicinal products. The GMP part comes when drying, curing, and packaging the flower. The basics behind a GMP-processing of cannabis flower is to reduce potential contamination while removing the water to an acceptable level. This enables the product to be processed and packaged for safe consumption with a designated shelf life. One of the key details to remember is that employees and product should move from room to room without backtracking. This reduces contamination risks but also allows for set procedures in the event of contamination.
There are levels of GMP for food-grade processing and medical processing. American hemp growers have moved to GMP standards for food-grade because of federal acceptance of hemp. Cannabis growers may only be held to GMP food-grade standards in the U.S. However, Europe will be holding the line at medical for a while. Either way, some level of GMP certification will occur for worldwide cannabis producers to be accepted by developed countries. Notably, GACP and GMP regulations have been slowly merging together to achieve higher quality medicines. This might prove to be a significant hurdle for cannabis producers that want to enter that level of the market.
Manufacturing cannabis has to fall inside the realm of GMP since either a food or medicinal product is being created. The classification of food vs. medicine vs. supplement will define not only how the product and people flow, but more importantly the equipment and clean room tech that is needed to qualify for a GMP-certified facility and product.
As an example, if cannabis is processed as a medicine, all equipment used must be qualified as pharmaceutical, GMP-compliant equipment. These are more stringent contamination rules than food and supplement grade, as they involve not only the internal parts but the exterior encasing of the equipment. To go a step further, the cleanroom tech for medicine must have HVAC systems that circulate and clean the air much faster than food-grade GMP. Standardized medicinal or food-grade manufacturing of cannabis ensures that the products are made to ensure customer safety. The reporting around transparency on all levels is critical to ensuring product safety.
As the ambiguity of cannabis regulation ends and the UN has voted to treat cannabis as medicine, GMP will be the standard of the world stage. The U.S. and other adult-use countries may opt to treat cannabis as a food product similar to liquors. Other minor cannabinoids like CBD may be classified as supplements.
There will also be a place for medical cannabis products both in the U.S. and other countries since there are different uses and ranges of acceptance. Either way, the world moves, GMP standards will be adopted throughout the cannabis industry alongside all the other products we use on a daily basis.