Make no mistake — federal cannabis legalization is coming soon.
Yet it won’t be the get-rich party that many cannabis stakeholders envisioned in 2012. Instead, strict new regulations will take hold of the industry, forcing small producers out of business.
Good Manufacturing Practices (GMPs) — the standards that assure product quality and safety across many industries — will become the new normal. Cannabis companies, no matter how small, will suddenly need to be GMP-compliant.
So how can you implement GMPs for your cannabis company now? How can you use GMP to be more efficient, future-proof your business, and secure new investments?
At AssurPack, we know how GMPs apply to our business, and how they’ll likely apply to yours. Our engineers have more than 100 years of combined experience in the pharmaceutical and consumer packaged goods industries, and have served as consultants to international pharmaceutical firms.
In this two part series, we take a look at how GMP concepts will apply to the cannabis industry, and how GMPs for cannabis companies will affect your future.
What Types of Cannabis Companies Need to be GMP-Compliant?
If you’re reading this guide, the answer to the above question is probably “yours.” If you’re a cultivator, processor, or infused product manufacturer, your company will need to be GMP-certified.
The Food & Drug Administration (FDA) requires GMP compliance for pharmaceutical manufacturing, as well as food, dietary supplements, cosmetics, and medical devices. Basically, any product that’s entering a human body needs to be manufactured and handled under GMP guidelines to ensure safety and consistent quality.
As you begin to think about GMP, consider the nature of your product. Are you a cultivator? An extraction service provider? Or are you producing CBD edibles? The nature of your product will influence which type of standards you should reference.
The future of cannabis manufacturing regulations is still a little hazy (as we discuss below). But it’s a good idea to base your GMP plan on the guidelines that apply to similar products.
You can compare these sections of the Code of Federal Regulations for GMP info that may be relevant to your product type.
- Food: 21 C.F.R § 110
- Pharmaceuticals: 21 C.F.R. § 210
- Dietary supplements: 21 C.F.R. § 211
- Cosmetics: 21 C.F.R. § 700
- Medical devices: 21 CFR §800
What is GMP?
GMP is a multi-faceted system that ensures products consistently meet safety and quality standards. It applies to many aspects of production — not just the product itself.
Parts of a GMP Compliance Plan
- Personnel training
- Materials and product
- Facilities and maintenance
- Record Keeping
- Incident investigation
- Product Development
A common GMP adage is that “quality cannot be tested into the final product.” So, instead of reactive testing, GMP proactively builds quality into the product at every step. It’s a forward-looking approach for quality assurance (QA) rather than a reactive method of quality control (QC). It aims to eliminate all the risks that end-of-the-line testing can’t.
There are other Good Practices standards which may apply as well, such as Good Agricultural Practices (GAP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP). The acronym GxP describes all of these standards together.
However, GMP is not a fixed set of rules that govern production. They’re a collection of guidelines that apply flexibly and sensibly on a case-by-case basis. And they evolve over time. As technologies improve and change, manufacturing standards do too. As a result, you may see them referenced as Current Good Manufacturing Practices (CGMP).
And GMPs aren’t a single set of standards. The European Union has its own set of GMP standards, as do Japan, Australia, Canada, and the World Health Organization (WHO). Many of these nations hold Mutual Recognition Agreements (MRAs) whereby officials in one country accept the GMP standards held in another. In this way, MRAs enable international trade without the stumbling block of multiple certifications.
How Will GMPs Apply to Cannabis?
Strangely, federal regulators may not apply GMP to cannabis, at least not directly. If the FDA takes the same approach it’s used for tobacco, manufacturing regulations could be unique.
In 2009, congress established a specialized regulatory agency for tobacco, the FDA Center for Tobacco Products. The same may happen for cannabis. But a cannabis-specific FDA agency will no doubt draw from GMP standards — or raise the bar in particular areas.
Yet GMP standards already apply to cannabis. Many companies — particularly larger grow ops — have obtained GMP certifications for a variety of reasons. In states such as California, regulators require GMP-compliance.
Other companies get a GMP certification to expand their reach into new markets. Europe is increasingly cannabis friendly. But, to do international business — or even to engage in interstate domestic commerce — American businesses need to be GMP-certified. And in the case of international partnerships, they may want to secure a European GMP certification (EU-GMP) rather than the US variant.
What Agency Certifies GMP Compliance?
Independent certification bodies provide auditing services, verifications, and certifications — not the FDA.
The FDA does not certify GMP compliance, though it has the right to audit manufacturers to make sure they are following FDA guidelines. Even in the case of multiple defect reports, the FDA rarely performs an on-site audit. Their usual response is a warning letter to the manufacturer.
Instead of the FDA, a variety of private independent certification bodies issue GMP certifications. GMP certification bodies often serve as consultants for a variety of standardization schemes, too, such as those set forth by the International Organization for Standardization (ISO).
For legal reasons, not all certification services will work with cannabis or hemp companies. You may find some GMP certification services for cannabis. Some may offer deeper GMP consulting services to help develop products and processes.
Can GMP Actually Help Cannabis Companies?
Why — you may be asking — would an over-scrutinized industry such as cannabis voluntarily take on more regulations? Why would you pay for an audit?
Leading cannabis companies know that GMP makes them more efficient and adaptable to changes. It lays the groundwork for good production habits and explicates how tasks should be performed by employees. With formal standard operating procedures (SOPs), cannabis companies have a baseline for employee training and an excellent tool for complying with state cannabis laws.
A GMP-compliant facility is less likely to have recalls or be liable for product defects. As we’ve seen in recent years, recalls can devastate cannabis companies.
GMP-compliance improves the reputation of a cannabis company, which has several benefits. You’ll earn the trust of consumers but, moreover, you’ll attract investors. And when (or if) it comes time to sell your company, a GMP certification will increase your perceived value.
GMP vs. Cannabis Testing
The cannabis industry has over-relied on testing. State lawmakers have struggled to know how to apply safety standards to the new industry. The best solution — until now — was testing, testing, and more testing. End-of-the-line testing was the only protection for consumers.
By contrast, other industries apply GMP to build safety into production rather than checking for it at the end. When the production methods pass quality tests, there’s less question about the product itself. With GMP in place, in-process testing is often sufficient for safety, rather than testing every batch of product as the cannabis industry must do now. Moreover, GMP guidelines recommend testing within the production workflow, which eliminates problems before they start.
Developing a GMP Plan
What are the next steps in the GMP journey? Most companies kick things off by working with a consultant or certification body to assess the changes they’ll need to make.
A consultant can audit your operation and compose a “gap” plan. It will detail everything that needs to change before certification. The gap plan may prescribe changes to facilities, equipment, or procedures. And it will certainly entail revised documentation policies, SOPs, and employee training standards.
If GMP certification sounds like a complex process, it’s because it is. And fulfilling the requirements set forth in a gap plan may be expensive too, depending on your facility and operations.
In the next part of this two-part series, we’ll explore what your GMP gap plan might look like, and common steps for becoming GMP-compliant. You might be closer to GMP-ready than you think!