How To Get Your Cannabis Company GMP Ready

How To Get Your Cannabis Company GMP Ready

Historically, the cannabis industry has not been under any legal obligation to take current Good Manufacturing Practices (cGMP) standards into account in their operations. Since Prohibition continues on the federal level in the U.S., GMP regulations that impact mainstream industries like food and beverage, cosmetics, and pharmaceuticals don’t apply to the largely underground cannabis industry. That doesn’t mean they’re not important to follow, though: These guidelines are crucial to ensuring product quality; without the implementation of GMP standards, many cannabis companies are not able to promise a consistent, quality product to their customers.

However, as Prohibition swiftly comes to an end in many American states and in the international community, it is a near-certainty that GMP standards will soon apply to cannabis manufacturers. Many manufacturers who are not GMP ready will find themselves unable to meet GMP certification requirements, limiting their ability to pass scrutiny with consumers, regulators, and potential business partners. Additionally, they will limit their ability to export to many regions internationally.

It’s essential that cannabis companies prepare now for this eventuality, no matter how far away the possibility may seem. Those who wait for the regulations to catch up will already be behind, but those who implement a GMP ready manufacturing process today will enjoy a strong competitive advantage.

What does it mean to be GMP ready?

The phrase “GMP ready” means a manufacturer is confidently prepared to attest to GMP standards, should they undergo the GMP certification process managed by one of the many third-party auditors authorized to certify manufacturing operations as compliant with GMP standards.

GMP standards already apply to most other major industries focused on the production of consumable goods. They’re designed to ensure that products are made with the highest quality standards and safety procedures possible. GMP standards are typically maintained by a government agency in the manufacturer’s country or countries of operation. In the U.S., GMP standards are governed by the U.S. Food and Drug Administration (FDA).

These standards influence every aspect of a manufacturer’s operations, from the facility itself to personnel training to recordkeeping practices. While GMP standards allow for manufacturers to establish unique processes, they must meet all requirements on an ongoing basis in order to be GMP ready.

GMP ready vs. GMP certified

GMP ready does not mean a manufacturer has gone through the GMP inspection process and received certification. It merely means a manufacturer expects that they would pass the audit should they undergo one. A company that is said to be GMP certified is one that has actually gone through the GMP audit process.

The GMP audit process requires inviting third-party inspectors to the manufacturing facility for an inspection at the company’s own expense. This can be a costly process, but enables a business to say they are GMP certified with the documentation to back it up, rather than just GMP ready or “GMP compliant.”

Why cannabis manufacturers need to be GMP ready

Cannabis manufacturers need to be GMP ready because, as the world continues to legalize cannabis for medical and adult-use sales, it is inevitable that these standards will come to the legal cannabis industry.

In some businesses, compliance with GMP standards is legally required, such as in the pharmaceutical industry or certain sectors of the food and beverage industry. Others, however, are not legally mandated to follow GMP standards. Still, being GMP certified, or at least GMP ready, is generally seen as a mark of a reputable brand by consumers, partners, regulators, investors and virtually anyone else you might want to do business with.

As a result, being GMP ready (and, eventually, GMP certified) should be a major focus for any cannabis manufacturers who are serious about operating in the legal cannabis industry in 2022 and beyond.

Improving product quality

GMP standards aren’t an arbitrary set of regulations, but instead a comprehensive list of best practices that, taken together, boost product quality and even efficiency in the manufacturing process. While complying with GMP standards generally requires upfront investment in the right compliant manufacturing equipment, the establishment of strict standard operating procedures (SOP), and building the infrastructure needed to maintain stringent records on raw materials and production, the result is a better product that will pass muster with regulators and earn the admiration of consumers.

Reducing risk and liability

A GMP ready facility is less likely to encounter incidents like on the job injury, equipment malfunctions, fires, and contaminated products. By following GMP standards closely, manufacturers can reduce the risk of accidents; while no manufacturing facility can ever be 100 percent insulated from workplace hazards or incidents, being GMP ready reduces the likelihood these adverse events take place.

Additionally, should an accident occur, a GMP ready facility will have comprehensive documentation about the process, materials, equipment used, maintenance, and safety procedures leading up to and immediately following the incident. This can serve to protect manufacturers from certain liabilities regarding workplace accidents or product recalls, enabling businesses to survive even the most trying times.

5 tips to make sure your cannabis business is GMP ready

Acquiring a GMP certification takes time and financial investment before, during, and after inviting a team of certification inspectors to your facility. Ensuring that everything is properly set up and all considerations have been covered ahead of time will reduce the risk of wasted investment as a result of a failed GMP inspection.

Becoming GMP ready is no easy task. These five tips, however, offer a few ways to make the process a bit easier.

1. Build or acquire a GMP compliant facility

GMP compliance begins with a facility that is built to cGMP standards, from the equipment brought into the building to the rafters criss-crossing the ceiling. Whether constructing a facility from the ground up or acquiring an existing building, ensure that your property meets a checklist of the most up to date GMP standards – if not, take the time and make the investment to bring it up to code. Although this may seem like an expensive and difficult process now, the payoff down the line will be well worth it.

When it comes to selecting equipment for your facility, make sure everything is third-party certified for safety and reliability. One of the highest standards in fire prevention, for example, is UL certification, which is offered by Underwriter Labs. UL certification guarantees that the electrical components in the machinery have been inspected by independent experts and determined to be safe for industrial use. By purchasing UL certified equipment, you can check off a major box on your road to becoming GMP ready.

2. Assemble a team of skilled professionals with demonstrable experience

Everyone on your staff from the lowest level to the C-suite should have clear experience in their respective fields, whether that is cannabis extraction expertise or supply chain management. GMP compliance starts from the top of the organization with the founders and CEO, who set the standards for all personnel throughout the organizational hierarchy. When recruiting and hiring for open positions, consider how prospective candidates bolster your manufacturing company’s ability to be GMP ready.

Consider also creating a position for a GMP compliance manager, who can stay on top of new developments in cGMP standards and ensure all operations meet the existing requirements. Establishing a dedicated internal position focused solely on becoming and staying GMP ready can help considerably as you grow your business. Moreover, it gives regulators and independent GMP auditors a direct liaison to communicate with about all matters related to cGMP standards.

3. Establish detailed SOPs and strictly enforce them

The way you run your manufacturing facility is critical and must be established in repeatable SOPs. Your entire team must be thoroughly trained on these SOPs, and supervisors must ensure that these SOPs are always being followed to the letter in the manufacturing process. Leave no detail to chance; SOPs should cover each manufacturing process that occurs in your facility, so if you’re performing multiple different types of cannabis extraction you must develop individual SOPs for each.

Also consider establishing SOPs and contingency plans for when things go wrong. Emergency response plans regarding equipment failures, fires, natural disasters and more demonstrate attention to detail and a dedication to safety for both personnel and product quality that are the hallmarks of a GMP ready manufacturer.

4. Work with GMP certified suppliers

GMP standards don’t just cover what happens in your facility, but also the standards your suppliers are held to. You must analyze your entire supply chain – all the way back to where you source raw materials – to ensure your manufacturing business meets GMP standards.

To reduce the chances your suppliers hinder your ability to be GMP ready, scrutinize them on the frontend. Ensure that all raw materials are sourced ethically with fair labor practices and in a manner that is environmentally-friendly. For cannabis manufacturers, it is also critically important to test products like cannabis flower to ensure they are free of contamination before beginning the manufacturing process (and also to comply with local and state laws governing cannabis testing).

If you determine that a supplier is not GMP ready, it is best to do business with someone else – even if your raw materials come at a heightened cost. To reduce the likelihood that a supplier falsely claims they are GMP ready, look for GMP certified businesses to work with instead.

5. Document everything about your products and processes

Documentation is king when it comes to being a GMP ready cannabis manufacturer. Tracking the source of your cannabis flower, your manufacturing processes and methods, your personnel, SOPs, and any workplace accidents or hazards is all an important part of demonstrating compliance with cGMP standards. To be GMP ready, virtually every aspect of your operations and supply chain must be meticulously tracked and organized in a transparent, accessible archive.

Get your cannabis manufacturing business GMP ready now

Make no mistake, GMP standards will soon apply to the legal cannabis industry. For cannabis manufacturers, there is still time to get ahead of the curve, but the window is rapidly closing. Now is the time to perform a comprehensive GMP audit of your facility and operations; anything that falls short of meeting cGMP standards should be replaced and updated.
When it comes to cannabis manufacturing equipment, Holland Green Science offers fully GMP certified and UL rated (or UL ready) equipment designed to support GMP certification attestation. As a company led by supply chain experts and veteran cannabis manufacturers, we know what it takes to be GMP ready. So, when you need a reliable supplier for your cannabis manufacturing facility, choose Holland Green Science.

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