ISO 9001 and cGMPs for the Cannabis Industry

By Scott Dawson
March 21, 2023

What are the Certifications needed for the Cannabis Industry?

The cannabis industry has boomed in the United States. Every year, more states relax their laws for medical and recreational cannabis. But those same changing regulations can also cause confusion. What exactly is required of cannabis manufacturers and growers in today’s regulatory landscape? What certifications will state, local agencies and important customers want to see?

Every state and customer will have different needs, but you can satisfy almost all of them with two basic certifications: GMP and ISO 9001.

If you’re unfamiliar with one or both of those terms, don’t worry. This article will explain the basics and show how cannabis manufacturers of any size can apply them to meet regulations and satisfy customers.

The Current Landscape for Cannabis Manufacturing Requirements

Because cannabis has not yet been legalized on a federal level, the U.S. Food and Drug Administration (FDA) does not have authority over cannabis production. But as the industry grows and federal laws change, the FDA may someday have greater authority over the process.

However, individual states have their own rules and regulations, overseen by different regulatory bodies. Some states have over a dozen different agencies involved in cannabis regulation. Some states may even require you to meet the full FDA guidelines for dietary supplements FDA CFR 21 Part 111. Your adherence to these state-required quality procedures may even affect your product testing requirements.  If you manage laboratory services, you may even need to secure lab certification with the ISO 17025 standard.

Then you have customer requirements. As your business expands and you branch out to larger customers, what requirements will they expect you to meet? Even if your home state doesn’t hold you to rigid quality standards, an important customer might.

So in a world of uncertainties, with requirements changing from state to state and customer to customer—how can a cannabis manufacturer prepare?

ISO 9001 and GMP for the Cannabis Industry

We recommend cutting through the complexity of two widely-recognized quality standards: ISO 9001 and GMP. These standards work hand in hand. The combination will cover almost any certification need you to face—and it will certainly put you well on your way toward meeting any others.

With the foundation set by ISO 9001 and GMP/cGMP, you will be ready for almost any regulations that come your way. But these standards do more than help you meet regulations. They also help you avoid costly recalls and produce consistent quality products to boost customer satisfaction and bolster your bottom line.

What is the Difference between GMP and cGMP?

GMP stands for “Good Manufacturing Practices.” Much like a management system, it consists of processes and documentation. The FDA sets the requirements of this standard, but state regulators or customers may also require you to follow it. GMPs ensure safety, consistency, and high quality for food, cosmetics, and pharmaceuticals.

GMP is the most common quality standard in the cannabis industry. In fact, some states have already instituted GMP certification as a requirement for cannabis manufacturing.

A somewhat stricter requirement, cGMP stands for “Current Good Manufacturing Processes.” Manufacturers who follow cGMPs must adhere to the most current GMP requirements.

For a full overview of GMP and cGMP, you can visit our GMP page. But for the sake of cannabis manufacturing, here are some of the most important principles to keep in mind:

  • To meet GMPs, you must follow a quality control system. An ISO 9001 quality management system can achieve this requirement, and it’s a common compliment to GMP certification. More on that is below.
  • You must design and control your facility to ensure proper handling and storage. The goal is to prevent contamination.
  • You must follow labeling requirements for your cannabis products. This includes accurate ingredient lists.
  • Cannabis products must be tested by a third party.
  •  You must ensure traceability. This means keeping thorough records of lots and batches at every stage of the manufacturing process.
  • Documentation is key. Your policies, procedures, test results, batch records, and training records should all be documented. Documentation will also play a key role in ISO 9001 certification.

GMPs and cGMPs may seem overwhelming at first glance. But even a small manufacturer can follow these requirements and achieve success—especially with the help of ISO 9001.

What is an ISO 9001 Quality Management System?

ISO 9001 makes world-class quality management possible for any business of any size. It’s a system of documents and processes built to fit any type of business, producing continual improvement and customer satisfaction.

ISO 9001 comes from the International Organization for Standardization. Experts from around the world join together to define globally-recognized best practices for quality management. The result: a quality management system (QMS) that can apply to any organization in any industry. The most recent revision was published in 2015.

To achieve continually improving quality, ISO 9001 builds on several foundational ideas. These include risk-based thinking and the process approach—a way of breaking your business into controllable processes. The entire standard follows the PDCA Cycle: Plan, Do, Check, Act.

Plan: In the planning stage, you evaluate your risks and opportunities, define the customer requirements and regulations you face, set quality goals, and plan accordingly.

Do: In the doing stage, you implement those plans and policies into your actual workflow.

Check: In the check stage, you review your performance to see whether the actions you took achieved the goals you set.

Act: In the act stage, you act on your findings, correcting anything that fails to meet your quality goals.

By following this cycle, you ensure consistent growth and customer satisfaction. For a fuller overview of ISO 9001 and its requirements, you can visit our ISO 9001 page.

ISO 9001 also serves as the foundation for many other international standards, such as ISO 45001 for Operational Health and Safety, and ISO 14001 for Environmental Management. This makes ISO 9001 an excellent foundation to future-proof your business for customer requirements down the road. If you follow ISO 9001, you can easily implement other ISO standards as the need arises.

ISO 9001 and GMP Integrated

At Core, we believe that ISO 9001 is one of the most efficient, effective ways for small businesses to meet the quality management requirements of GMP. These two standards work hand in hand. If you’re certified to one, you’re already well on your way to the other.

Quality management sits at the top of GMP and cGMP requirements, and it undergirds every part of the GMP process. Everything you achieve with GMP will become easier with the structure created by a solid quality management system. ISO 9001 is the most widely recognized quality management system in the world—and it’s designed to fit the needs of your business.

The flexibility of ISO 9001 makes it a perfect fit for a shifting, growing industry like cannabis manufacturing. It’s designed to work around your unique context. This means that, as cGMPs and government regulations change, ISO 9001 remains flexible. It adapts to whatever external requirements you face, whether those requirements come from customers or regulatory bodies.

When you work with a company like Core Business Solutions, you can implement ISO 9001 and GMP seamlessly together. Expert consultants can show you where the standards overlap and support one another, so you can get the full benefit of GMPs and ISO 9001 compliance while avoiding redundancy.

Combined, these two standards can help any cannabis manufacturer, regardless of size, produce world-class quality. By following GMP and ISO 9001, you will be ready for whatever requirements come your way. More than that: You will be ready to face risks and seize opportunities.

How Core Can Help

At Core Business Solutions, we help American small businesses achieve success with ISO 9001 and GMP. Our expert consultants bring years of industry experience to every project. We know the needs of small businesses. We know how daunting government regulations and customer requirements can seem. We’ve been there. But we also know that any business of any size can achieve success.

Our approach combines web-based tools, hands-on consulting, and practical training to make ISO 9001 and GMP work for your business. For more information, you can give us a call at 866-354-0300 or contact us online for a free quote.

 

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