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.”
GMP vs cGMP
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!
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.