If you’ve been watching the moves of big cannabis companies lately, you’ll notice the acronym “GMP” being used more commonly. What is GMP, and how does it relate to the cannabis industry? Why is GMP important?
Here at GrowFlow, we understand that with the various standards, regulations, and legislation governing all the seed-to-sale processes in cannabis, it can get a bit confusing. What exactly needs to be done to cross the Ts and dot the Is before products hit the hands of consumers, and more importantly, why? Here we break down what GMP means and how it fits into the cannabis industry.
Back to GMP Basics
GMP stands for Good Manufacturing Practices, which are principles for ensuring that food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices have been produced according to a set of standards for quality and safety. They are sometimes listed as cGMP, with the “c” standing for “current”. GMP or cGMP standards ensure that products are utilized for their intended use and provide consistency between production and product batches with the main goal to prevent harm to the user.
GMP standards are followed for most products worldwide. In the United States, all products mandated to receive GMP status will receive that from the Food and Drug Administration (FDA) by applying for a GMP Declaration. They are governed in the U.S. by the Food Safety Modernization Act, and the Federal Food, Drug, and Cosmetic Act.
This set of principles pertain to employee hygiene, facility hygiene/maintenance, equipment and utensils used in production, sanitation practices, warehouse and distribution, processes and controls, and many other aspects of making safe and quality products.
GMP for the Cannabis Industry
At present, since cannabis is federally illegal, there is no requirement that cannabis products follow GMP standards. However, industry trends suggest that these standards will become adopted across the board, especially as cannabis expands internationally, further permeates the pharmaceuticals and nutraceuticals markets, and faces the possibility of being federally legalized.
With this quick move towards regulation, and as the cannabis and hemp industries look at what’s next for regulations, it’s safe to say that adopting GMP within facilities and processes now will save cannabis companies a lot of time, and headache, in the future.
How to Prepare for GMP Certification
At GrowFlow, we understand that adhering to a new set of processes on top of standards that you already may be following may seem daunting, yet pursuing this set of standards will be worth it in the end. Undertaking these standards ensures that you don’t put the health or safety of your customer at risk, preserving the integrity of your brand.
The process of undertaking GMP standards may seem a bit less overwhelming if you break it down step by step. Here are a few things to consider when preparing for GMP certification:
Familiarize Yourself with GMP Standards
There is no central document that says what the GMP standards are or how to achieve them for one’s industry. Instead, they are a set of principles that companies abide by in their manufacturing processes, and they vary between product categories.
Access best practices from other companies that align with your cannabis product category. For instance, if you’re producing a cannabis topical, observe and learn from the GMP practices of the cosmetics industry. If you’re developing what you deem a pharmaceutical-grade product, look to the GMP practices of pharmaceuticals, and so on.
For products in the USA, it’s always best to consult the FDA website, as they have the most up-to-date information on requirements for GMP Declaration.
Develop Strong SOPs
Standard Operating Procedures, or SOPs, are the key to running a successful operation, whether you’re cultivating, processing, or delivering cannabis products. SOPs are controlled documents that instruct employees on completing their tasks so to be compliant with internal and external regulations.
SOPs can take many forms but must be standardized and in compliance with the state under which a cannabis business is licensed. SOPs outline all the procedures in detail on how things are done to remain consistent in practice and act as a record for any process changes.
Many cannabis companies look to outsource their SOP writing rather than invent their own or rely on business management and compliance software to develop these intricate and important documents.
When developing SOPs for your cannabis company, it’s important to understand the GMP guidelines surrounding the product you’re making so to ensure SOPs are in line with these standards if they were to be mandated.
Ensure Your Records Keeping Processes are Air Tight
Operating a legal cannabis business means you have to ensure that you have your records keeping processes air tight, regulated, and up-to-date.
Ensure that you have business management and compliance software that includes a) batch system tracing for product recall, and b) retention of documents with records of edits, users, and dates. Ensuring you have the batch system tracing in the event of a product recall will allow you to trace back to the production batch, the manufacturer potentially the harvest batch, depending on the nature of the product recall issue. Ensuring this traceability allows you to look back into the processes and standards used for that batch to fix any compliance or potential safety issues.
Build Nimble Processes
Even if your SOPs are deemed airtight, adhering to GMP standards may require certain methodologies to be changed or adapted to be more GMP compliant. Having nimble processes will ensure that your cannabis company is able to adapt to new standards.
For instance, food, drug, and dietary products are required to have certain indicators on their labels that cannabis products don’t yet have to adhere to under the same regulations. However, cannabis companies specializing in certain product categories like edibles should consider what needs to appear on a GMP compliant label, beyond just what’s required by state cannabis law, and plan space, design, and printing accordingly.
Hire a Compliance Consultant
Most cannabis companies have in-house Compliance Officers managing all parts of the seed-to-sale process and are using business management and compliance software to ensure state compliance. If your facility or cannabis business is considering pursuing GMP compliance, hire a consultant that is trained specifically in GMP and cGMP, spanning all industries.
A consultant’s role will be to bring the cannabis company from compliant with state and industry standards to compliant with GMP standards so that when the time comes, that company can receive the GMP Declaration.
Allay Consulting is a service provider serving the hemp and cannabis industries nationwide. They guide companies through compliance strategy ensuring the best practices making sure the product you create ends up in stores and not disposed of.
GrowFlow Can Help
GrowFlow has experienced its growth alongside the industry, and as such, we understand the challenges that cannabis companies face when they are expected to adhere to new regulations.
Are you unsure about whether your facility or cannabis company should be adapting to GMP standards? Reach out to talk to us about our business management and software compliance software and how we can help in your GMP journey.