GMP-CERTIFIED CANNABIS WORKFLOW

THE ULTIMATE GUIDE TO GMP CERTIFICATION FOR CANNABIS

Have you heard about GMP Certification for Cannabis, but you’re not sure what it is? Or perhaps you know what GMP is, but aren’t sure if it’s relevant to your business. We get it. Information and resources for GMP as it relates to cannabis cultivation are scattered and confusing. But don’t worry, we’ve done the heavy lifting for you! In this guide, you’ll find all the information you need to get you and your commercial cannabis operations fully up to speed on everything GMP.

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Section 1:

What is GMP?

What Does GMP Have To Do With the Cannabis Industry?

GMP stands for Good Manufacturing Practice.

In other words, it’s a set of rules and procedures related to the handling, cleaning, quality assurance, and packaging processes in manufacturing facilities and the products they make.

Regardless of the licensing authority, the category under which cannabis is produced (medical or recreational use), or the form of the end-product (flower, concentrate, edible), cannabis is considered a drug and is subject to the various regulations and guidelines governing drugs.

Many jurisdictions around the world require the application of Good Manufacturing Practice (GMP) in the manufacture of drugs intended for their marketplace including:

  • Canada
  • United States
  • Australia
  • New Zealand
  • Japan
  • European Union

Mutual Recognition Agreement (MRA) countries define GMP as the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, and required marketing authorizations.

Essentially, good manufacturing practice ensures that a food or drug product is safe for human consumption.

WHAT ARE THE CONSEQUENCES OF NOT APPLYING GMP?

Whether the cannabis is being grown and produced for local (in-state or in-country) consumption or export abroad, virtually all cannabis legislation requires some level of production quality assurance. While it is not always, GMP is the standard that pharmaceutical companies need to apply to the production of their medicines, and the production of medical cannabis is no different. The application of GMP to the harvesting and production of cannabis means the end-user can be sure that what they buy is safe to consume and that it is consistent each time they buy it.

While it’s true that many jurisdictions do not have GMP requirements for cannabis products, it’s almost certain that in the future, cannabis regulators will require certification for Licensed Producers (LPs) to receive and maintain their license. Even now, sales opportunities may be lost by not maintaining GMP certification. More and more consumers will expect to see the certification on the product they buy. For business-to-business cannabis sales, many LPs are already requiring a GMP certificate from any other LPs they buy product from.

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Section 2:

GMP REQUIREMENTS

BASIC REQUIREMENTS OF GMP

There are many requirements for GMP, but this guide will focus on those aspects of GMP that relate to the harvesting and trimming of cannabis. Citations will be sourced from Canada’s GMP Guidelines which are harmonized with the requirements of other MRA countries.

At a high level, the basic requirements of a GMP program for cannabis harvesting and trimming can be summarized into the following:

  • Manufacturing processes are clearly defined and controlled to ensure consistency and compliance with approved specifications and procedures
  • Critical steps of manufacturing processes and significant changes to the process are validated
  • All necessary key elements for GMP are provided, including the following:
    • Manufacturing processes are clearly defined and controlled to ensure consistency and compliance with approved specifications and procedures
    • Critical steps of manufacturing processes and significant changes to the process are validated
    • Qualified and trained personnel
    • Adequate premises and space
    • Suitable equipment and services
    • Correct materials, containers and labels
    • Approved procedures and instructions
    • Suitable storage and transport
  • Instructions and procedures are written in clear and easy-to-understand language; and
  • Operators are trained to carry out and document procedures.

DIVING INTO THE DETAILS OF GMP

To get to know GMP, we need to dive into the details. The following section provides an in-depth review of the GMP requirements related to equipment, personnel, and sanitation. This is directly from the Health Canada guidelines and can be a bit complicated and difficult to read.

Cleaning Violation Guidelines

Once you have the equipment, personnel and sanitation program in place, it is necessary to validate the cleaning procedures that are employed. The following are the GMP guidelines for cleaning validation.

 

Rationale:

  • The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients, and/or cleaning agents as well as the control of potential microbial contaminants. In addition, one needs to ensure there is no risk associated with cross-contamination of active ingredients.
  • Cleaning procedures must strictly follow carefully established and validated methods.
  • Appropriate cleaning procedures must be developed for all product-contact equipment used in the production process. Consideration should also be given to non-contact parts into which product may migrate (e.g., seals, flanges, mixing shaft, fans of ovens, heating elements, etc.).
Plain English Translation

This is where it all comes together. You’ve done the prep work, made the right equipment selections, put in place SOPs and trained your team. But does it all work as intended? Are you achieving the level of cleanliness required for your operations? These guidelines help you determine if your cleaning protocols and execution are adequate or need adjustment.

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Section 3:

GETTING READY

HOW DO I GET MY OPERATIONS GMP-READY?

HOW DO I GET MY OPERATIONS GMP-CERTIFIED?

If you’re located in Canada, you’ll need to work with Health Canada’s Health Products and Food Branch Inspectorate. To get a jump start on the certification process, check out Health Canada’s GMP Audit Report Form.

As cannabis is not yet federally legal in the United States, GMP certification through the US Food & Drug Administration is not available, but more information on their GMP requirements can be found here: FDA cGMP Regulations.

Section 4:

ADDITIONAL RESOURCES

Edible Cannabis Products and HACCP

Hazard Analysis Critical Control Points (HACCP) is an internationally recognized system used to enhance food safety throughout the food chain. A HACCP System consists of prerequisite programs and a HACCP Plan. Prerequisite programs are outside the HACCP Plan, but still within the HACCP System. They keep potential hazards from becoming serious enough to adversely impact the safety of foods produced. GMP is an example of a prerequisite program. The purpose of the HACCP Plan, or Food Safety Plan, is to prevent, eliminate or reduce potential food safety hazards to an acceptable level.

When making any cannabis-containing edible product, many raw ingredients, including cannabis will be required. If the company producing the edible is following HACCP, they will implement a prerequisite program to ensure that incoming materials (i.e. the raw ingredients) are safe and of good quality. Procuring cannabis from a GMP-certified supplier would meet this prerequisite by verifying the quality of this particular input material, thereby providing justification for not adding the processing of cannabis to the HACCP Plan.

 

Conclusion:

Using cannabis from a GMP-certified supplier to produce an edible product does not negate the need for a HACCP Plan, but it does eliminate the need to consider the cannabis ingredient itself as a potential source of hazard that must be addressed in the HACCP Plan.

Using the Mobius in a GMP-certified Environment

In the past, one of the major obstacles for an LP that sought GMP certification was the cannabis trimming process, mostly because the hoses and dust collection components of the equipment were nearly impossible to clean and potentially carried contamination from one batch to the next. With the Mobius Trimmer M108S, we set out to design a cannabis trimming system that could be operated, cleaned and put back into operation with minimal fuss.

Here’s how we did it:
  • All plant-touching parts of the M108S are smooth and made of non-toxic, corrosion resistant, non-reactive materials, capable of withstanding repeated cleaning;
  • All plant-touching parts of the M108S are accessible and/or removable for cleaning and can be effectively cleaned with non-toxic detergents or just water alone;
  • The M108S does not have any hoses or hidden parts, which are exceptionally difficult to clean and have the potential to harbor microorganisms;
  • The M108S is a semi-closed system that generates minimal airborne particulate because the system separating the trim from the flower is built into the machine; and
  • SOPs for the M108S are simple and straightforward, ensuring a quality standard and consistency in operations and products.

The table below goes into detail on each of the trimming-related GMP guidelines and the pertinent Mobius feature.

Requirements

Equipment
GMP Requirement Mobius Feature
The equipment does not add extraneous material to the end product. Plant touching parts are smooth and made of non-toxic, corrosion resistant, non-reactive materials, capable of withstanding repeated cleaning All plant-touching parts of the Mobius are smooth and made of non-toxic, corrosion resistant, non-reactive materials, capable of withstanding repeated cleaning

All parts of the Mobius are entirely resistant to shedding (anodized metal, molded plastic, surgical-grade stainless steel, etc.)

Equipment made of material that is prone to shed particles does not come in contact with plant materials All parts of the Mobius are entirely resistant to shedding (anodized metal, molded plastic, surgical-grade stainless steel, etc.)
The possibility of lubricant or other equipment maintenance material contaminating the product is minimized The Mobius is designed with all sealed bearings. Any other parts that could possibly require lubricating are closed off from those parts that touch the plant.
Belts and gears are enclosed or properly covered The cutter drive belt on the Mobius is fully encased and does not come into contact with any plant material
Operational
Cleaning

NOTES ON EQUIPMENT AND OPERATIONAL PERSONNEL

The more complex a piece of equipment is to operate or to clean, the more complex and lengthy SOPs and instructions will be and the more difficult it will be to adequately train personnel.

The ability of an organization to adequately train its personnel is increased by having simple SOPs and decreased by having high turnover. Ideally, an organization will aim to have simple operational procedures in place that are executed by thoroughly trained and experienced personnel. While an organization can take steps to increase employee retention, the results of those efforts may not always be as successful as hoped and even under the best circumstances, some level of employee turnover is inevitable. With this in mind, it behooves LPs to keep their SOPs for trimming and cleaning as simple as possible so that they can onboard new employees quickly and effectively.

Sample GMP Audit Form – Equipment Section

The following table has been excerpted from Health Canada’s GMP Audit Report Form (FRM-0211). Section C.02.005 of the form pertains to equipment and has been completed assuming that the Mobius M108S is being used for trimming operations.

Equipment [C.02.005]

The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that:

(a) permits the effective cleaning of its surfaces (Yes / No)
(b) prevents the contamination of the drug and the addition of extraneous material to the drug (Yes / No)
(c) permits it to function in accordance with its intended use (Yes / No)

If yes, describe.

If no, provide a rationale (e.g. Not applicable because…)

 

Deviations

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. (No. / Observations / Risk Classification)

 

Corrective actions

Detail the corrective action(s) taken and/or to be taken.

 

Attachments

Attach supporting documentation such as SOPs, action plans with timelines for each corrective action identified above.

Recommended Reading

Business News Network

While not specifically a cannabis-industry source, they provide more and better coverage of the industry than just about anyone. Not only that, much of their coverage includes interviews and videos. Their content is from a business perspective (of course), and does tend to focus on Canadian companies, but that’s because they’re the biggest players in the game. Check out their Marijuana News page to stay up-to-date.

 

Marijuana Business Daily (AKA MJBizDaily)

Marijuana Business Daily provides a good, focused look at not only the business, but also cannabis policy and political news from around the world. They are a news aggregator, so often gathering stories from external sources, but they do write their own deep coverage of important issues. A recent example was their province-by-province series looking at the policy rollouts here in Canada, and great coverage of the recent changes in California.

 

The Cannabist

It’s for all things cannabis, not just for news. Their news section is great though. They mix in the more entertaining/less informative stories with the hard coverage, which is great for a lunch-break read (ex: Grandparents caught in Nebraska with 30lbs of pot gummies in the car). They’re located in Denver, so carry a lot of Colorado-centric stories, but they still have coverage from around the US and Canada.

 

Marijuana.com

From the folks behind Weedmaps, Marijuana.com provides more feature writing than many of the other sites, thanks to scribes Monteray Bud and Duke London. Their coverage volume is lower than most on this list, with maybe 3-4 exclusive pieces per week, but the quality is very good.

 

Lift.co

Lift is known for their strain reviews, but the news section on Lift’s site is getting better and better. They have a substantial list of contributors, including many that hold full-time positions at major players in the cannabis industry. They don’t aggregate stories from other sites, which is refreshing. Since they’re a Canadian company, much of the content is Canadian-focused, but so are we, so we’re okay with that.

 

GMP & Marketing

Being able to include GMP as part of your brand messaging is just one more benefit of seeking this level of certification, but a valuable one. Read more about how the GMP certification for cannabis has become a marketing tactic to leverage with investors and consumers.

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