GMP vs cGMP in the CBD Manufacturing Industry

Topics Covered In This Article…

GMP: “Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.”


Welcome to our on the article on GMP vs cGMP. This article is brought to you by Spring Creek Labs, a U.S. Based CBD Manufacturer and Private Label CBD Product Fulfillment Company.

In this article, we’ll look at the differences between GMP (Good Manufacturing Practices) and cGMP (current Good Manufacturing Practices). We‘ll also look in-depth at what GMPs are, what the six sections of GMPs are, and what types of inspections and certifications are required or advised.


The CBD/hemp industry is new and is just coming under the guidance of federal law, but enacting GMPs is a requirement to sell anything in the United States. When you’ve completed this blog, you should have a solid grasp of what GMPs are, the six sections of GMP implementation, and what’s expected from CBD manufacturers. Let’s jump right in!

Go to Article Home – 

Summary of GMP vs c GMP

Good Manufacturing Practices (GMP) are defined by the US Food and Drug Administration (FDA) as the minimum standards that manufacturers of food, drugs, supplements, etc. must meet to be allowed to manufacture and sell in the United States. Any product not meeting these minimum standards is considered adulterated and can’t be sold legally in the US.

Current Good Manufacturing Practices (cGMP) is a recognition by the FDA and industries that current best practices change faster than legislation can be drawn up. 


Go to Article Home – 

Title 21 (21 CFR) and GMPs

Title 21 is the section of US federal law that governs the FDA’s ability to enforce good practices. There are several sections that govern GMPs by industry:

  • 21 CFR 117 (Food and edibles)
  • 21 CFR 111 (Dietary supplements)
  • 21 CFR 211 (Pharmaceuticals)
  • See draft guidance for cosmetic GMPs

The various portions of 21 CFR aren’t complete. There is no packaging and labeling guidance in the food section (117), but it’s there for pharmaceuticals (211). That’s why cGMP is the real standard. It’s based on accepted industry practices as put forth by both the FDA and the various industries. The FDA offers a slideshow that looks more closely at all the laws and regulations governing cGMPs.

The CBD industry touches on all of these areas. One hemp production plant might create CBD for beverages, food, supplements, and cosmetics. The plant should meet and exceed the written standards, as well as those created within the industry.

Because the industry is so new and most of its production is covered by the existing laws, the FDA hasn’t created separate guidance for CBD production. It’s unlikely that it will need to.

For CBD made from marijuana, those containing THC, there is no guidance since THC is illegal at the federal level. As a matter of industry standard, those companies manufacturing CBD from marijuana use the same cGMP guidelines for their productions.

Go to Article Home – 

The Six Sections of cGMP

According to the National Cannabis Industry Association, cGMPs have six major components that lead to success. Each of these six components must be in place to ensure that GMPs are part of the DNA of a company. The six components are: Management Commitment, Risk Management, Quality Management Systems, Site & Facility Management, Product Controls, and Staff Training.

  • Management Commitment – Too often issues of regulation are short-changed by management. Management runs around like crazy before an inspection, then gets lax again as soon as the inspector leaves. In order for cGMPs to be effective and avoid recalls and incidents, the management team needs to see them as standard operating procedures (SOPs). Enforcing the cGMP guidelines should be part of everyday activity for the management team. This commitment should be from the top down. The C-Suite needs to be as aware and committed to cGMPs as the shift managers.
  • Risk Management – This is where another creation of the US federal government can come in handy: HACCP (Hazard Analysis Critical Control Point) practices were designed by NASA to guarantee that food for the Apollo 11 astronauts was safe. Today, this system ensures that manufacturing plants for human and animal foods only turn out healthy, uncontaminated foods. The HACCP systems can be applied to CBD manufacturing. In an excellent introductory article, Cannabis Industry Journal discusses how the powerful hazards reduction system can benefit the CBD and cannabis industry. Using HACCP guidelines for risk management in the manufacturing process will make a world of difference when it comes time for inspections and certifications.
  • Quality Management Systems – “A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.” – QMSs codify the procedures of the HACCP and cGMP within a company. Many portions of a QMS can be automated, from temperature checks to purity testing. The purpose of the QMS is to make quality a team effort, not reliant on a single individual.

Industry Warning: Many hemp and CBD companies are small, just a few people. Quality, safety, and GMPs often fall onto a single person. This needs to be avoided at all costs. Everyone in the company, from the CEO to the janitorial staff, needs to be part of GMPs and quality. GMP vs c GMP.

Too often, everything falls on that one individual and if they leave, get sick, or even take a vacation, quality and safety suddenly drop.

As an entire industry of startups, it’s important that every cannabis business recognizes the importance of these procedures and actions, not just for regulatory reasons, but to guarantee that we satisfy consumers’ expectations.

  • Site and Facility Management – It’s important to remember manufacturing doesn’t happen in the vacuum of space. The building, land, and outbuildings are all part of the manufacturing process. If the roof of the building leaks, it can compromise an otherwise excellent manufacturing process. Site and facilities management is critical to ensuring that GMPs are enforced. Again, this is not a job for a single person. While a small company might have a single facilities manager, there should be at least two other staffers who are versed in what to look for and do inspections periodically. As the company grows, there should be a sites and facilities team that maintains everything to the highest standards to ensure that the building isn’t the reason the manufacturing process is compromised.
  • Product Control – This is the portion of the process where the product is tested and quality is maintained. Assuming the manufacturing process has been done correctly, the product should be in excellent condition as it arrives for packaging. The product is tested, shipping is factored in as a risk factor, and the final consumer product is guaranteed to be what’s expected. In the case of CBD, this will also refer to dosage of CBD in the final product. Since only 50 out of 50,000 doses might be tested, cGMPs are the only insurance against misdosing, mislabeling, and contamination.
  • Staff Training – This relates back to the sidebar above. cGMPs are everyone’s job, but staff can’t help ensure that cGMPs are being followed if they’re not let in on the guidelines and expectations. Staff should be taught about the laws that govern their jobs, the company as a whole, and the manufacturing processes. HACCP guidelines should be taught, as well as putting in place a procedure for staff to notify management of violations of cGMPs or HACCP. Most employees want their company to succeed, especially in the small start-ups that make up the bulk of the cannabis industry. By training staff on cGMPs, including the why’s and how’s, the entire company can take part in making sure that only the finest products make it to market.

Go to Article Home – 

GMP vs cGMP and Third-Party Audits

One of the best ways to ensure that your manufacturing process is adhering to cGMPs is to bring in an outside firm to do an audit. A cGMP audit examines every step of the manufacturing process, the building, and more to ensure that everything is up to current industry standards.

Accredited auditing bodies are the way to go. These are organizations that have subjected themselves to verification by outside accreditation bodies. An accredited auditing firm guarantees that they’re using the latest GMP vs cGMP standards, using the highest audit standards, and providing the right information for their clients.

When seeking a cGMP certification firm, look for accreditation from reputable organizations. The National Cannabis Industry Association recommends three organizations:

The cGMP auditor you choose should be accredited by one of these three organizations to ensure they are complying with international standards.


Go to Article Home – 

ISO and cGMP

Often, you’ll hear that a factory or company meets one of several “ISO” standards. ISO is the International Organization for Standardization. It’s a non-governmental body that has created standards for industries around the world.

Many firms will seek ISO certification in order to show consumers around the world that they meet certain standards.

Both ISO and GMP measure the effectiveness of quality controls and manufacturing processes. ISO also focuses on customer satisfaction, whereas GMPs don’t concern themselves with the end consumer. GMPs are focused on the processes that will produce a pure and safe product.

While ISO standards are high, meeting ISO standards doesn’t mean that a plant or a company will meet GMP standards since they address two different things. GMP vs cGMP.

Go to Article Home – 

International GMP

The European Union (EU), the World Health Organization (WHO), the United Kingdom (UK), and the United States (US) all have different standards, but they are substantially similar. Cannabis Industry Journal provides an excellent quick overview:

The World Health Organization (WHO) version of GMP is what’s used by pharmaceutical regulators worldwide. The European Union’s EU-GMP standards are seen as roughly equivalent, as are those now practiced in the U.S. by the FDA. That does not mean that confusion does not reign as standards are changing (across Europe, for example, between individual countries, there is still disagreement). However similar GMPs are used in countries including Australia, Canada, Japan, and Singapore. The UK, of course, is slightly different than anyone else but still has regulations that are roughly equivalent and referred to as “The Orange Guide” (in honor of the color of the book’s cover)

While firms selling only in the US don’t need to worry about international standards, any firm seeking to export their products will need to look to the standards for the countries they want to expertise in. Even Canada, being a close neighbor, has its own standards that every firm must meet.

Go to Article Home – 

Meeting cGMP Standards

The cannabis industry is very new. While there has been a large push to make it as professional as possible, there’s still a perception among consumers that it’s an industry filled with stoners who don’t take business seriously and don’t understand regulations or compliance.

In reality, most cannabis companies work hard to meet every guideline, regulation, and law. It can be a struggle because, as we noted before, a single CBD plant can produce “pharmaceuticals”, supplements, cosmetics, and food. A single facility needs to meet the cGMPs for each of those processes.

Meeting cGMP Standards

For management in the cannabis CBD industry, the key is to work hard to meet cGMPs, hire a third-party auditor, and keep staff educated on the guidelines that everyone is trying to meet. Make cGMPs part of the company’s DNA. This will prevent a lot of regulatory hassle and reduce the possibility of a recall of products because of contamination.

Go to Article Home – 

Get Your Private Label CBD Quote Now

  • This field is for validation purposes and should be left unchanged.

Scroll to Top