Good Manufacturing Practices (GMP) ensure that companies create safe, reliable products through a consistent set of documented processes. Currently, in the U.S., only cannabis cultivators and manufacturers in certain states must comply with GMP standards, but a future where universally required adherence is required will come.
Get your cannabis company ready now for GMP standards. This guide details GMP standards and what they might look like when it comes to cannabis cultivation and manufacturing.
What are Good Manufacturing Practices?
GMP standards are meant to ensure that all products are made with a process that consistently meets certain quality standards. Adhering to GMP — which the Food and Drug Administration (FDA) governs in the U.S. and the World Health Organization governs elsewhere — means establishing documented, repeatable processes that will always provide the same result: safe, high-quality products. GMP compliance is vital to the overall success of any company that desires to sell consumer products, including cosmetics, food, and eventually, cannabis.
What Does GMP Cover?
In cannabis, GMP covers cannabis cultivation, extraction, environmental and business sustainability, laboratory, packaging, labeling, security, retail and dispensary operations, and infused products. Its standards proactively assure quality in all stages of the cannabis production process. This includes:
- Equipment
- Premises
- Storage
- Hygiene
- Materials
- Product development
- Staff training
- Record-keeping
- Standing operating procedures (SOPs)
- Complaint management
Why Should You Care About GMP Compliance?
GMP compliance can give your cannabis brand a competitive advantage even if you don’t operate in any countries that participate in the WHO. Some ways GMP compliance can help you distinguish your brand from others include:
- Universally higher-quality products. GMP adherence minimizes the likelihood of contaminated or improperly dosed cannabis products. Your customers will get exactly what they’re seeking, with no dangerous or unexpected side effects.
- Customer satisfaction. If someone continually gets the same quality and experience from your cannabis products, you’ve gained a brand loyalist for life.
- Greater sales revenue.Passionate cannabis consumers are often willing to spend more on certifiably safe products. Complying with GMP gives you ample justification to increase your prices — and a high likelihood that you’ll still make plenty of sales.
- More prescription revenue. Some medical cannabis patients around the globe, like in Germany, have prescriptions and use insurance to cover their costs. Insurers may pay your brand more for GMP-compliant prescriptions than you’d get when selling directly to consumers.
The 5 Ps of Cannabis GMP
GMPs in cannabis allow manufacturers to arrive at their unique GMP-compliant process instead of following a strict set of rules. These guidelines include five main components, commonly referred to as the “Five Ps” of cannabis GMP. Cannabis cultivators and manufacturers can work toward GMP compliance by focusing on each of these factors.
- People: Establish and document proper training by developing safety protocols, providing personal protective equipment (PPE), and offering extensive cultivation training. Systematically track and record your team’s day-to-day work, and clearly write out all roles and responsibilities.
- Premises: Maintain high-quality safety standards when designing your cultivation and manufacturing facilities. Account for ventilation systems and, for extraction facilities, C1D1 and C1D2 zones. Use the storage conditions of your inputs and finished products to inform your design.
- Process: Create standard operating procedures (SOPs) describing every facet of your operations, and make sure your employees strictly follow these rules. Frequently revisit and update your SOPs in accordance with current best practices. You must pass the installation qualification (IQ), operational qualification (OQ), and processing qualification (PQ) process bars to become GMP-certified.
- Product: Conduct third-party testing to ensure consistent and repeatable processes, high-quality and safe products, and accurate labeling. Implement inventory tracking to universalize product sourcing, shipping, and storage conditions.
- Procedures: Your administrative team should track and enforce your brand’s manufacturing processes throughout your facility, from safety and emergency protocols to organizational hierarchy. Detailed recordkeeping is a must for effective tracking.
Cannabis GMP and what it means for cultivators
GMP certification is generally regarded as “when, not if” when it comes to the U.S. cannabis industry. While many cannabis cultivators choose to ignore GMP regulations, there’s no denying the importance of documented, repeatable processes and consistent results.
In Germany, for example, GMP certification remains the most basic requirement for any company producing medical cannabis and exporting it to the European Union. According to the European Medicines Agency (EMA), “Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.”
As cannabis legalization expands across the U.S., GMP standards will likely become the norm for this industry. Regardless of current regulations, any business that wishes to ensure safety and quality while showing consumers and partners its commitment to these values should make cannabis GMP compliance a top priority.
GMP certification in the EU
As the cannabis industry grows, it’s more important than ever that companies with international reach are prepared to enter markets overseas. This means that it’s essential for cannabis companies who want to enter the European market to obtain GMP certification, even if it’s not required in the U.S.
Because cannabis is considered a medical product in the European Union, GMP is a prerequisite for most cannabis companies operating in Europe. According to the EMA, all cannabis products must be manufactured and tested under formal conditions, including a listing in the Eudra Database European Medicines Agency. Generally, suppliers and partners in Europe are not likely to work with non-GMP-certified companies.
GMP for cannabis in action: New York
The New York Office of Cannabis Management (OCM) already enforces GMP requirements. According to its GMP Audit Guidance Document, adult-use and medical cannabis products in the state must be processed in a GMP-compliant manner. For the entire duration of your brand’s two-year licensure period, you are obligated to adhere to GMP standards in your processing facilities. OCM does not grant exceptions to this requirement.
OCM requires that adult-use cannabis licensees and registered organizations file proof of qualified third-party GMP audits within their first year of licensed operations. A new audit must be conducted after renewing a license. Some processors and microbusinesses may request exemptions from these audits.
GMP-certified vs. GMP-ready
“GMP-ready” generally means that a company has not received GMP certification from a third-party organization, but believes it would qualify if it did apply. The phrase “GMP-certified” confirms that a cultivator has gone through all or any of the steps of the GMP certification process.
How to learn about GMP for cannabis
Eager to make your business GMP-ready and, from there, earn GMP certification? Consider taking one or more of the following courses to more thoroughly understand what it takes.
- Online GMP Training’s Medicinal Cannabis Industry GMP Compliance Bundle
- Pharmout’s Medicinal Cannabis GACP / GMP Training
- USP’s Foundations of Good Manufacturing Practices
Cultivating cannabis with GMP compliance in mind
With the industry continuing to grow, there has never been a better time to prioritize cannabis GMP compliance. Designing your cultivation or manufacturing facility with the right equipment and methodology is the only way to ensure that your company will be prepared for GMP compliance and other regulatory changes.
Choosing top-quality machinery that meets GMP standards, including Cryo Cure’s line of patented freeze-drying machines, is a major consideration when setting up a GMP-compliant process. To learn more about how Cryo Cure can support your cannabis cultivation or manufacturing business, contact us today.
