GMP for Cannabis Will Change Everything: Part II

July 1, 2021

Most cannabis manufacturers acknowledge the importance of Good Manufacturing Practices (GMP) for safety. GMPs are the critical standards that ensure product quality and keep consumers safe.

Moreover, they recognize how GMP regulations will suddenly apply to the cannabis industry when federal legalization takes hold. Everyone will need to achieve GMP certification — and do so quickly.

But the path to GMP certification isn’t clear or easy.

You’ll need to reenvision certain procedures. But which ones? And you’ll need new documentation. But what types? And what about equipment?

In this post, we answer some hands-on questions about GMP certification for cannabis. Ultimately, GMP will benefit cannabis companies with greater efficiency and quality control — and the time to get started is now.

Step #1: Determine Which GMP Certification You Need

Good Manufacturing Practices aren’t universal; individual countries apply their own sets of standards. The standards in the United States, which are officially titled Current Good Manufacturing Practices (CGMP), are a bit different from the European Good Manufacturing Practices (EU-GMP).

If your intention is to engage European markets, it behooves you to pursue certification to EU-GMP standards, rather than CGMP. EU-GMP is more directly applicable for importing products to Europe. Even if a GMP Mutual Recognition Agreement applies (as described below) EU-GMP will streamline your international sales.

Mutual Recognition Agreements (MRAs) enable a particular set of GMP standards to apply in other countries. Regulators in the US recognize the credibility of an EU-GMP certification, and vice versa.

Yet overseas regulators may not recognize foreign GMP standards because of cannabis’ pending legal status. It’s important to double check.

However, preparing for any GMP certification will make it easier to achieve the next. EU-GMP and CGMP are similar. If you’ve achieved either certification, you can likely achieve the other with few operational changes.

Step #2: Perform a Gap Analysis

A GMP gap analysis shows where your operation stands now versus where it needs to be for GMP compliance in the future.

The gap process starts with an understanding of requirements as they apply to your situation and an assessment of the areas where you’re falling short. Ultimately, you’ll create a detailed how-to plan for harmonizing with GMP. Most plans include a project timeline.

At this point, you may want to bring on a consultant to assist with your GMP certification and gap analysis. But you can get started without the expense of their involvement, and you can better understand the process by thinking through some of the particulars yourself.

Ultimately, when federal legalization hits, cannabis product manufacturers will need to reference every applicable clause in Title 21 of the Code of Federal Regulations regarding GMP.

But for now, an easier means of sizing up your current situation is to look west to California. California has developed detailed definitions for cannabis quality control, as well as standards for cultivation. Their regulations are a good initial reference for companies in the early stage of a GMP gap analysis, and can be found through the California Cannabis Portal.

Note: California’s regulations are included here as an easy-to-understand description of how GMPs apply to cannabis. They don’t apply to other jurisdictions and shouldn’t be used as a defining document for a CGMP or EU-GMP certification.

Per California, your gap plan will include sub-checklists for:

  • Buildings and manufacturing premises
  • Equipment and utensils
  • Personnel
  • Cannabis product components
  • Manufacturing processes and procedures
  • Supervision roles
  • Standard Operating Procedures and documentation

An Example

Here’s an example of how you might reconcile regulations with your production plan.

Per the California’s cannabis regulations (17 CRR §40243), “equipment shall be installed so as to allow the cleaning and maintenance of the equipment and adjacent spaces. Equipment that is not easily moveable shall meet the requirements of Health and Safety Code section 114169.”

That means you’re headed down the rabbit hole of the California Health and Safety Code.

So, your checklist would then need to include items from section 114169 of the health code. Depending on your current situation, many elements of 114169 may apply, such as 1.) ensuring the equipment is elevated on legs that provide a six-inch clearance to the floor, or 2.) sealing equipment to the wall if it is subject to spillage.

Your completed gap analysis will yield your gap plan: a well-organized to do list with a detailed timeline for completion.

But fulfilling every requirement of your plan may take over a year in some cases.

Step #3: Update Your SOPs and Documentation

Standard Operating Procedures (SOPs) are only one part of documentation. The other components are your quality manual, policy documents, and recordkeeping system.

Review Your SOPs

You probably already have SOPs. But they may need more detail or restructuring based on the items in your gap plan.

Many companies find that their actual procedures have drifted away from their written SOPs. This can happen due to incremental process improvements or because employees habitually perform tasks differently than they should.

Your SOPs will naturally follow from your GMP requirements. If a task calls for hairnets, donning a hairnet will be part of the GMPs.

All your SOPs — from equipment maintenance to production, from facility upkeep to record keeping — will be dictated by GMP. The important part is that they’re customized to your facility, products, and equipment.

Good SOPs have flowcharts, checklists, and even pictures if a task is prone to misinterpretation. They’re easily readable. And they include some info on why a task needs to be performed — not just how. Employees need to understand the importance of what they’re doing, too.

Not sure if your SOPs are clear? Try them. Follow the instructions literally and see if the task is accomplished.

Revisit Policy Documents

Policy documents are different from SOPs. They describe how GMP policies will be implemented in general terms, without the step-by-step structure of SOPs. They’re a narrative format of how you will apply GMP principles to your tasks.

Policy documents are similar to many licensing applications. Like SOPs, they explain the “how” yet they do so more conceptually and generally.

Create a Quality Manual 

Most cannabis companies do not have a quality manual. A quality manual describes the overall Quality Management System (QMS) that you have in place. Again, this document mirrors the applicable GMP requirements and tailors them to your facility.

If you’re subject to an audit, a quality manual presents the auditor with some initial info to introduce your operation. It can help them — and you — appreciate the scope and strategies of your QMS.

Step #4: Conduct a Trial and Mock Inspection

Before jumping into the next steps of GMP certification, try out the methods you just devised. Run your facility based on your documentation, equipment configurations, and processes.

You’ll probably need to adjust your new programs over the course of several months. Only when you’re functioning as a GMP-certified facility should you attempt certification.

A mock inspection can determine if you’re ready for a real GMP inspection. At this point, a trained consultant can help you identify problems and correct them. Their services will include a review of your documentation, as well an in-person facility inspection.

Foregoing a mock inspection can leave you exposed to risks during a real one, including wasted money and damage to your brand’s reputation.

Step #5: Get Inspected and Certified

Finally, after months of work and a successful mock inspection, you’re ready for the real deal.

The Food and Drug Administration does not certify your GMP compliance. You’ll need to choose an independent certification body to do that.

These third-party experts specialize in certifications to a variety of standardization schemes and multiple variants or GMP, such as CGMP or EU-GMP. For legal reasons, not all of these organizations work with cannabis companies. However, with some internet sleuthing, you’ll be able to find a certification body with cannabis experience.

The Final Step: Call AssurPack®

Packaging has its own set of GMP considerations — both on our side of the supply chain and yours. We need to maintain high manufacturing standards, and you do too.

Our packages meet all of your GMP and cannabis regulations with:

  • Food-grade plastics
  • Child-resistant certification (CPSC-certified)
  • Production in GMP-certified facilities

Food-grade packaging ensures your product arrives in your customers’ hands free from byproduct chemicals. That’s an important — and often overlooked — aspect of quality control.

Are you aiming for GMP certification? We can help. Our packaging engineers can assess your production floor to recommend GMP-friendly packages and packaging technologies to increase your speed and lower your labor costs. Contact an AssurPack® representative today.