Understanding GMP for Cannabis Extraction Labs

Cannabis start-ups around the world are looking to meet the growing demand for pharmaceutical grade cannabis distillate, but unless you have an engineering background, you may find yourself wondering what GMP regulations are and how they will impact your business. The purpose of GMP standards is to protect consumers from sub-par quality products by enforcing strict reporting, equipment cleaning, quality management, and documentation and application of standard operating procedures (SOPs).

“Essentially, GMP ensures a universal minimum standard of quality to protect consumers (Cannabis Business Executive).” GMP stands for Good Manufacturing Practices and outlines a set of requirements throughout the production process for foods, supplements, and pharmaceuticals to ensure those products meet quality control standards.

It’s first important to note that the application of GMP principles in the cannabis industry is fairly new, as governing bodies would not recognize the legitimacy of working with hemp or cannabis until it was decriminalized by the United States and other nations. As cannabis products become more mainstream globally for the treatment of many health conditions, we are seeing more and more involvement from governmental organizations to ensure that cannabis products are meeting the highest standards of quality.

How GMP standards impact the cannabis extraction process (as well as the cultivation and product formulation processes) depends on where and how the finished products will be used. Pharmaceutical grade products are subject to the highest scrutiny and quality standards, even more so than food grade products. For the cultivator, extractor, or product formulator, the question isn’t whether GMP will impact their work, but to what level of GMP standards they must confirm to.

While they are the costliest to abide by, pharmaceutical grade GMP standards create the best consumer products, and satisfy all other classes of GMP standards (food grade, nutraceuticals, dietary supplements, etc.). It is safe to say that if your facility and extraction lab meet pharmaceutical grade GMP standards, your finished product will be accepted by local Authority Having Jurisdictions (AHJs) wherever cannabis products are legal for sale and consumption.

• Design, construction, and location of all equipment must permit easy cleaning, sanitizing, and inspection. Maintenance and usage logs must be kept up to date.
• Personnel must be aware of the principles of GMP that affect them. Operators must be trained to carry out and document procedures, and training records must be properly maintained. Instructions and procedures are written in clear and easy-to-understand language.
• A written sanitation program will ensure the cleanliness of the premises, of any and all equipment used in your operations, and ensure employees are trained in and follow all required sanitation procedures.

• Lab surfaces are selected to permit easy cleaning. Hatches provide access to difficult to clean areas. Maintenance and upgrades are the responsibility of extractX and staff are trained to update usage logs.
• extractX manages the hiring and ongoing training for all lab staff. Staff are trained to document procedures up to GMP pharmaceutical standards. Documented standard operating procedures (SOPs) are provided by extraxtX.
• Staff are trained on sanitation procedures for all surfaces and equipment. Staff are trained to maintain proper usage logs of all cleaning and sanitation activities.

If you’re exploring the pharmaceutical grade cannabis product market or want to elevate your product quality from food grade to pharma, you may be able to leverage an extractX mobile lab. These labs are built to pharmaceutical grade GMP standards off-site and delivered to your facility ready to operate within 4 months of contract for $0 lab CapEx. Please contact us to learn about becoming an extractX partner.