Cracking the Code: The Secret to GMP and Organic Certification in the Hemp Industry
Are you ready to dive into the world of hemp industry semantics? We all know that language is a powerful tool, and in the hemp industry, paying attention to the language used to describe products and processes is crucial. When it comes to extraction, terms like 'GMP Compliant' or 'Organic' are often thrown around, but are they really what they seem? Let's explore why semantics matter in the hemp industry.
PREFACE – BUILDING TRUST AMONGST MY OUR READERS
As a Control Union team member, I've seen the good, the bad, and the ugly of hemp extraction facilities, on nearly every continent, in countries where medical cannabis and hemp are legal. Some facilities take pride in calling themselves pharmaceutical-grade and they produce top-quality cannabinoids, while others are downright deceptive and dangerous. Our team has witnessed the harsh realities of failed audits and broken promises. But we do this work to ensure that consumers around the world can trust the products they're buying. When you see the RHS stamp by Control Union, you can rest assured that the product is of superior quality, safe, and regulated - no wild west here!
NAVIGATING THE COMPLEX WORLD OF GMP: A GUIDE FOR HEMP EXTRACTORS
WOW, you’re 'GMP Compliant' that sound impressive! But it’s not and it's important to understand that 'compliant' is not the same as 'certified.' In fact, 'compliant' simply means that a company has implemented a set of good manufacturing practices (GMPs), but it doesn't necessarily mean that they are being audited by a third party to ensure that they are following those practices. On the other hand, 'certified' means that an independent third party has verified that a company is following a set of GMPs.
CONSUMER INSIGHTS: VIEWING GMP THROUGH THE EYES OF THE CUSTOMER
As a consumer, GMP certification is critical because it ensures that the products we use and consume meet the highest quality and safety standards. It's important to note that GMP certification isn't just limited to pharmaceuticals, but is also widely used in the food, dietary supplement, and cosmetics industries. In fact, GMP was created as a response to a tragic mishap in the drug API world in the 1950s involving a drug called Thalidomide that caused severe birth defects in newborns.
To ensure that the products you buy are both effective and safe for you to use, it's essential to look for GMP certification. GMP stands for Good Manufacturing Practices, and it requires companies to meet strict requirements and guidelines. These include implementing standard operating procedures, maintaining thorough documentation and record-keeping systems, and using qualified personnel and equipment. Additionally, the company must undergo rigorous inspections by third-party auditors to receive certification. Basic engineering stamps such as UL, ASME, ASTM, NSF, and FDA are also essential to ensure the safety and quality of the equipment and materials used to make the product.
It's crucial to understand the difference between a GMP "qualified" and "certified" facility. A qualified facility meets the minimum GMP requirements but hasn't undergone the full inspection process to become certified. On the other hand, a certified facility meets all of the GMP requirements and has undergone a comprehensive inspection. So, when looking for products with GMP certification, it's vital to know the difference between these two terms to ensure that you are getting the highest quality and safety standards for your products. By looking for GMP certification and those five engineering stamps, you can be confident that the product you're using is safe and effective.
REVVING UP FOR QUALITY: WHY HEMP TEAMS ARE RACING TO ADOPT GMP STANDARDS FOR THEIR FACILITIES
So, you're interested in GMP certification, but you're not quite sure what it means? Well, let me tell you - GMP stands for Good Manufacturing Practices, and it's all about ensuring that your products are safe, effective, and high-quality. To get GMP certified, you'll need to meet a whole bunch of requirements, including some basic engineering stamps like UL, ASME, ASTM, NSF, and FDA. But that's not all - you'll also need to have detailed documentation of your processes, rigorous quality control measures, and a commitment to continuous improvement. It may seem like a lot of work, but trust me - it's worth it. Not only will you be able to assure your customers that your products are top-notch, but you'll also be able to sleep easy at night knowing that you're doing everything you can to keep them safe and healthy. So go ahead, get certified, and let your GMP flag fly!
FOOD VS PHARMA GMP CERTIFICATIONS: WHICH ONE IS RIGHT FOR YOUR HEMP BUSINESS?
Good Manufacturing Practices, or GMPs, are a set of guidelines that ensure that products are made consistently and of high quality. While the basic principles of GMP apply to many industries, there are some differences between GMP for food and GMP for pharmaceuticals.
FOOD GRADE VS PHARMA GRADE GMP
Food GMPs are designed to ensure that food products are safe and of high quality. These guidelines cover everything from the quality of the ingredients used to the cleanliness of the manufacturing facility. Food GMPs are important because they help prevent contamination and ensure that the food we eat is safe and healthy.
Pharmaceutical GMPs are a bit more rigorous than food GMPs. They are designed to ensure that medications are safe and effective, and that they contain the correct ingredients in the right amounts. Pharmaceuticals have to go through extensive testing and clinical trials before they are approved for use, and GMPs play a crucial role in ensuring that the manufacturing process is consistent and produces a high-quality product every time.
GMP IN INDUSTRIAL HEMP
Now, when it comes to the hemp extraction space, it's important to understand that GMP guidelines for hemp fall somewhere in between food and pharma GMPs. While hemp products are not medications, they are often used for health and wellness purposes, which means that consumers expect a high level of quality and safety. This is why GMP certification is so important for hemp extraction facilities - it ensures that the products they produce are consistent, safe, and of high quality. It's important to note that initial extractions are usually not included in GMP certification. However, if an extraction facility isn't ICH Q7A and pharma grade GMP compliant, it may encounter some problems making the claim or “GMP”. That being said, discussing these issues is beyond the scope of this blog post, so let’s regain focus on the task at hand.
So, while there are some differences between food and pharma GMPs, the underlying principle is the same - to ensure that products are safe and of high quality. And when it comes to the hemp extraction space, GMP certification is the gold standard for ensuring that consumers get the high-quality products they expect and deserve.
In regulated industries such as food, pharmaceuticals, and hopefully the hemp extraction space if they can create regulatory framework that is not littered with grey areas allowing for opportunists, obtaining GMP certification is critical for companies. But GMP is not just about following strict requirements and guidelines; companies in the hemp space also need to ensure that their equipment meets certain safety and quality standards. Without the necessary basic engineering stamps, the possibility of not receiving GMP certification is greatly increased.
Below, are mentioned the basic 5 engineering stamps that are critical for equipment being used in a GMP certified facility.
The five stamps include UL, ASME, ASTM, NSF, and FDA.
UL (Underwriters Laboratories) - This stamp indicates that the equipment has been tested and meets safety standards set by UL.
ASME (American Society of Mechanical Engineers) - This stamp indicates that the equipment has been designed, constructed, and tested to meet ASME standards for safety and quality.
ASTM (American Society for Testing and Materials) - This stamp indicates that the equipment has been tested and meets ASTM standards for quality and performance.
NSF (National Sanitation Foundation) - This stamp indicates that the equipment has been tested and meets standards set by the NSF for safety, quality, and sanitation.
FDA (Food and Drug Administration) - While not an engineering stamp per se, equipment used in a GMP certified facility may also need to be approved by the FDA, which has its own set of regulations and standards for safety and quality.
Each stamp represents a different set of standards that the equipment must meet. UL ensures that the equipment has been tested for safety, ASME ensures that the equipment meets certain standards for pressure vessels and boilers, ASTM ensures that the equipment meets certain material and performance standards, NSF ensures that the equipment is safe for use with food and water, and FDA ensures that the equipment is approved by the U.S. Food and Drug Administration for use in food and pharmaceutical production.
These engineering stamps are critical for hemp extraction companies seeking GMP certification in the modern world of global markets and accountability. Ensuring that equipment meets these standards ensures that quality and safety are met in the products produced, and with these stamps equipment’s likelihood of receiving a GMP certification greatly increase. Not all equipment in the hemp space will come with the necessary engineering stamps, especially if it's cross-purposed from other industries or still in the prototype phase, so it's important to be mindful of what you're getting yourself into when considering equipment without the necessary engineering stamps.
While you might be sold on the dream of the equipment, making that dream a reality could be much harder than you think. This is especially true in the GMP space where safety and quality standards are high. If you're considering such equipment, be sure to consult with experts in the industry before making any purchasing decisions. It's better to be cautious now than to face costly problems later on.
PEELING BACK THE LABEL: THE TRUTH BEHIND 'ORGANIC' IN HEMP EXTRACTION
'Organic' can have different meanings depending on the program that's being used. Some states have organic programs that don't require third-party auditing to ensure that farms are adhering to organic standards. On the other hand, the USDA's National Organic Program (NOP) is highly regimented and requires auditors to visit fields to ensure that organic standards are being met.
So, it's important to take the time to understand the language being used in the hemp industry and to dig a little deeper to understand what those terms actually mean. By doing so, we can make more informed decisions about the products we use and promote transparency and honesty in the industry.
Understanding the meanings of GMP is a great first step, but knowing the difference between cGMP, food grade GMP, and pharma grade GMP is critical if we are going to move the hemp industry forward. We have to stop demanding recognition and start proving that we deserve to be in the same space as other commodities. The difference between a "qualified" and "certified" GMP facility can have significant implications for the quality and safety of products.
Furthermore, while we are on the subject of semantics, it's important to understand that the term "organic" can have many different meanings. Certified organic is critical for differentiating between "preferred methods" and "required" practices in the production of high-quality, safe products.
BUT THEY'RE JUST WORDS! KEEP YOUR REGULATIONS OFF OF OUR PLANTS!
Look, words have meanings, which is why we often run into words on company pages that look legitimate but, in reality, make false promises. In the hemp industry, we often hear about companies making label claims. Having a basic understanding of GMP and certified organic can help consumers and businesses alike distinguish between companies that are actually following proper practices and those that are not.
If you have more questions about GMP, organic certification, or any other aspect of hemp extraction, feel free to reach out to our team or Control Union. We have the expertise and experience to help you navigate the complex world of regulatory compliance, and we're always happy to share our knowledge with others. Unlike equipment manufacturers, we don't sell equipment and we have no stake in the game beyond creating a stabilized hemp supply chain for our network. Our goal is to help ensure that companies in the hemp industry have the knowledge and tools they need to produce safe, high-quality products that meet regulatory standards. So don't hesitate to get in touch if you need guidance or support.
To find information about a GMP certified facility in the United States, you can visit the FDA's website and search for the facility's name in the FDA's database of registered facilities, known as the FDA Establishment Identifier (FEI) database.
Here's how you can do it:
Go to the FDA's website at https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
Click on the "Search for Firm Name" box at the middle of the page.
Enter the name of the facility you are interested in and click "Search"
The search will list all companies with an FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility – this is a required identifier number of an FDA GMP certification.
If the facility is registered with the FDA, the search results should display the facility's FEI number, which you can use to check the facility's GMP certification status. You can then contact the FDA directly to verify the facility's GMP certification status.
The FEI number is a unique identifier assigned by the FDA to facilities that manufacture, process, pack, or hold FDA-regulated products. When a facility applies for GMP certification, the FDA will typically verify the facility's FEI number as part of the certification process.
It's worth noting that GMP certification is not mandatory under U.S. law, but many pharmaceutical and medical device manufacturers voluntarily seek GMP certification to demonstrate that they are committed to meeting the FDA's standards for quality and safety.