Have you been hearing about GMP, 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.
The Ultimate Guide to a
GMP-Certified Cannabis Workflow

.

Also available in the menu at the top right.
SECTION 2: WHAT ARE THE REQUIREMENTS?
SECTION 3: GETTING READY
SECTION 4: ADDITIONAL RESOURCES
SECTION 5: REFERENCES
Section 1:
WHAT IS GMP?
Chapter 1:
What Does GMP Have To Do With the Cannabis Industry?

GMP stands for Good Manufacturing Practices. 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, including Canada, USA, Australia, New Zealand, Japan and the European Union, require the application of Good Manufacturing Practices (GMP) in the manufacture of drugs intended for their marketplace. Mutual Recognition Agreement (MRA) countries[i] 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, as required by the marketing authorization [ii], [iii].
Essentially, GMP ensures that a food or drug product is safe for human consumption.


Chapter 2:
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 for export abroad, virtually all cannabis legislation requires some level of production quality assurance. It’s not always GMP, but GMP is the standard that pharmaceutical companies need to apply to the production of their medicines, and the production of medical-grade 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 in many jurisdictions there are no GMP requirements for cannabis products, it’s almost certain that in the future, cannabis regulations will require GMP 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 GMP certification from any other LPs they buy product from.
Section 2:
WHAT ARE THE REQUIREMENTS?
Chapter 3:
BASIC REQUIREMENTS OF GMP

There are many requirements that constitute 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[iv] 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 as follows:
- 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.
Chapter 4:
DIVING INTO THE DETAILS OF GMP

To really 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. Not ready? No problem. Skip ahead to the GMP Quick Start section.
Chapter 5:
CLEANING VALIDATION GUIDELINES [v]

Once you have the equipment, personnel and sanitation program in place, it is necessary to validate the cleaning procedures that are employed. Following are the GMP guidelines for cleaning validation.
PRINCIPALS
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.
Section 3:
GETTING READY
Chapter 6:
HOW DO I GET MY OPERATIONS GMP-READY?


Chapter 7:
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
Chapter 8:
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[vi]. 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[vii].
Chapter 9:
Sample GMP Audit Form – Equipment Section

The following table has been excerpted from Health Canada’s GMP Audit Report Form (FRM-0211[viii]). 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: | ||||||||||||
|
||||||||||||
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.
|
||||||||||||
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. |
Section 5:
REFERENCES
Chapter 10:
Endnotes

[iii] https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/vol4-chap1_2013-01_en.pdf
[iv] Good manufacturing practices guide for drug products (GUI-0001): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html
[v] Cleaning Validation Guidelines (GUIDE-0028): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028.html
[viii] Good Manufacturing Practices – Audit Report Form (FRM-0211), Health Products and Food Branch Inspectorate, Health Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/forms/audit-report-form-0211.html
Chapter 11:
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 | 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 GMP has become a marketing tactic to leverage with investors and consumers. |