Blog Extraction

What is cGMP/EU GMP, and How Does It Affect Cannabis Processors?

Safety is of the utmost importance, especially when dealing with medical products, including cannabis. To ensure that products are safe, pure, and contain what they’re supposed to, governments establish standards to keep products consistent.

What Is cGMP?

cGMP stands for “Current Good Manufacturing Practice.” It’s a standard meant to represent the current best manufacturing practices. “Current” is included to acknowledge that standards change.

In the U.S., the FDA has established the cGMP guidelines for all medical products. These guidelines apply to the products and the equipment and facilities producing them. The FDA publishes the specifications so that manufacturers of both the equipment and the products themselves can follow them.

The FDA doesn’t just leave it up to the manufacturers to police themselves. They inspect both products and facilities. That doesn’t just go for facilities in the U.S. The FDA sends inspectors to ensure that products made in other countries for export to the U.S. are up to cGMP standards.

The European Union has its own version of the GMP as well. It’s not exactly the same as the FDA’s version but similar. Like the U.S. version, the EU GMP applies to both the EU facilities and those producing products for export to the EU.

Why cGMP?

In just about any industry, there’s a need for standards. Regarding food and especially medical products, the need for standards is a matter of health and safety. While it’d be great to think that companies can regulate themselves, there are always unscrupulous ones looking to profit from deceiving the consumer. Then, there are just honest mistakes. Either way, standards, and testing ensure that everything works as it should.

The cGMP standards also help with standardization across regions. Each country has its own standards. Some are more stringent than others. Because cGMP standards apply to all medical products imported into the U.S., it shouldn’t matter where the products are produced or the laws and standards there. FDA inspectors will ensure that the products meet U.S. standards.

Manufacturing the Right Way

There are certain ways to gear the cannabis extraction process to cGMP standards without a lot of extra effort. When an operation and the equipment used are established to play into and even exceed cGMP standards, there won’t be any need to worry about or frequently update them to stay ahead of standards.

Automated systems, like the ones designed and built by ENTEXS, are excellent for ensuring that cGMP standards are met. Automation both tightly controls key specifications and greatly reduces the potential for contamination.

With automation, it’s possible to set specifications for temperatures, cannabinoid concentrations, and other essential factors in the extraction process that either influence the end product quality or need to fall within cGMP standards on their own. The system will continually monitor itself and adjust these factors to remain within the desired parameters.

Automation also decreases the need for human intervention. It contributes to the system’s overall efficiency and precision and helps reduce the possibility of contamination. Contamination can occur even under the cleanest conditions. Any time the product gets exposed to the open air, there’s a chance something unwanted will get in. Human intervention only increases the likelihood of contamination. ENTEXS systems are completely closed-loop from end to end and are fully automated with convenient controls to manage all the key parameters for your extraction operation.

It’s also crucial that the equipment be designed and built to cGMP standards, using materials that meet those standards. Materials like stainless steel and their grades meet the cGMP standards and are easy to clean and maintain. It’s also vital that the systems get constructed in a fashion that conforms to cGMP standards. That’s why ENTEXS systems are designed, engineered, machined, and fabricated in-house in the U.S. by industry-leading professionals.

ENTEXS not only designs and builds every part of each system in-house, but we also install it as well. This way, we can tailor your system to your facility, ensuring both meet cGMP standards. Your extraction operation can easily pass GMP and FDA approval with a seamless, tailored approach using high-quality materials and high building standards.