New Year, Fresh New Company Goals

Looking to set new company goals for 2025? Achieving quality and safety certifications can give your business a significant competitive edge! Certifications not only differentiate you from your competitors, but in some states, they are required or even come with incentives. They can improve workplace efficiency, enhance customer confidence, minimize the risk of recalls, increase your business’s value, and better prepare you for regulatory inspections. Additionally, a surprising benefit we’ve noticed is an increase in employee satisfaction after certifications are achieved—employees appreciate the clarity of pre-established expectations.

The cannabis and psilocybin industries offer numerous certification options. We often get asked which ones are best. The answer depends on your company’s specific goals. Below is an overview of the most popular certifications within the industry. While there are many more certifications available, these are the most in-demand. No matter which certification you pursue, be sure the certifying body is accredited, meaning it has been audited and approved by a higher authority to uphold recognized standards.

Current Good Manufacturing Practices (cGMP)

Current Good Manufacturing Practices (aka cGMP) is a set of standards that were created by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act and cover manufacturers of food, dietary supplements, cosmetics, medical devices, and pharmaceutical drugs. cGMP requires a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. cGMP certification is specific to the facility, each production facility will need their own certification. This quality management system helps to ensure products are made consistently and reliably to product specifications for identity, strength, quality, and purity. Not only does cGMP help businesses prevent hazards such as contamination or errors, but it also ensures that products are safe for consumers, every time. Most large retailers (such as Walmart, CVS, etc.) require this certification prior to selling products.

The cGMP certification is best suited for manufacturing and processing facilities. This includes processing after harvest and begins with trimming through extraction, infusion, packaging and storage.

Good Agricultural and Collection Practices (GACP)

Good Agricultural and Collection Practices (GACP) provides the industry direction on cultivation, collection (aka harvesting), and primary processing practices specific to medicinal plants. Primary processing includes washing, cutting before drying, fumigation, freezing, etc. The GACP standard was developed by the World Health Organization (WHO) in 2003 with the focus on improving the quality of medicinal plants used in retail. According to the WHO, the GACP guidelines:

• Contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines, which aims to improve the quality, safety and efficacy of finished herbal products;
• Encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.

The GACP certification is best suited for cultivation, harvesting, and primary processing facilities.

ISO 9001

ISO 9001 is a standard that sets out the requirements for a quality management system holistically within the entire company. It helps businesses and organizations to be more efficient and improve customer satisfaction. This set of standards is based on the idea of continual improvement. In contrast to cGMP certification, ISO 9001 is suitable for organizations of all types, sizes, and sectors, not just the production facility. Similar to cGMP, some enterprises require ISO 9001 prior to engaging in business.

This certification is great for all types of companies!

ISO 22000

ISO 22000 is an internationally recognized Food Safety Management System that combines the ISO 9001 approach to cGMP standards, food safety management and HACCP for the assurance of food safety at all levels. The standard maps out how an organization can demonstrate its ability to control safety hazards to ensure that food is safe.

ISO 22000 can be used by any organization within the food supply chain. ISO 2200 is best suited for cultivation, manufacturing/processing, storage and distribution facilities.

Organic

There is a growing interest in purchasing organic products. A way to attract consumers is obtaining organic certification. Organic certification helps to demonstrate transparency to consumers that your product is grown or handled in an organic way that (according to the USDA) contributes to increasing water quality, conserves energy, increases biodiversity, and improves soil health. Both cultivation and processors may receive this certification. Unfortunately, the marijuana industry cannot yet receive organic certification but may continue organic practices. Hopefully, organic certification will be available to marijuana companies when federal legalization occurs.

Organic certification is often obtained by hemp cultivation and hemp manufacturing/processing establishments.

Certification Requirement Trending Amongst States

It seems more and more states are either requiring or incentivizing cannabis cultivation & manufacturing companies to receive certifications from accredited companies. This might be trending now, but if cannabis regulations are aligning with the FDA’s requirements surrounding quality and safety, obtaining certification is one easy way to ensure you’re in compliance when FDA regulation begins. Even if your state doesn’t require or incentivize certification, the long-term success of your business should focus on the safety and quality of your products. If this trend attracts more states, are you preparing for certification?

Some States Require Certain Certifications, While other States Provide a Benefit with Gaining Certification

Colorado

Hemp safe harbor registrants must demonstrate compliance with the FDA’s cGMP for food or dietary supplements before registering or within 12 months after the previous registration. The safe harbor registrant must obtain a cGMP audit from a department approved third-party accredited auditing company, and every year after.

Florida

Florida Department of Health requires medical marijuana processing facilities to obtain a cGMP certification by an accredited certifying body within 12 months after licensure. If the facility does not pass their audit, the facility is required to immediately stop processing until it can demonstrate to the department that the facility has met the requirement.

Maryland

Maryland mandates that manufacturers of medical marijuana edibles and dietary supplements, including medical marijuana products, comply with current Good Manufacturing Practices (cGMP) and 21 CFR 111 requirements.

Michigan

Michigan Cannabis Regulatory Agency (CRA) requires infused beverage manufacturers to obtain or provide evidence companies are in the process of obtaining cGMP certification by an accredited certifying body. Other cannabis producers and cultivation have an incentive to receive cGMP and/or GACP certification through CRA’s reduced sampling and testing requirements.

Missouri

All cannabis businesses in Missouri, including cultivators, processors, dispensaries, and testing labs, are required to implement a Quality Management System (QMS) based on published standards. GMP certification is a state-mandated requirement for medical marijuana producers in Missouri. Licensees must establish a QMS within one year of receiving departmental approval to operate.

New York

Under New York State’s Office of Cannabis Management Hemp Program’s regulations, THC & hemp processors are required to maintain a third-party cGMP certification for the duration of the license term or provide a detailed plan for obtaining the certification within six months of approval of the application and before beginning operations as a processor. The GMP audit must be conducted by a state-approved GMP auditor. This audit serves as evidence of compliance with GMP standards and is a prerequisite for obtaining a cannabinoid hemp processor license.