GMPs, or ‘Good Manufacturing Practices’, are a set of practices which are necessary in order for a product to conform to the guidelines of various regulatory agencies around the world. GMPs mainly affect pharmaceutical products, tobacco products, cosmetics, and foods. These practices were implemented so that manufacturers could not cut corners, enabling the safe production of products for consumer usage.
Since the CBD industry has been rapidly unfolding and developing all sorts of new products containing CBD, the FDA hasn’t been able to keep up with the huge demand in the market, thus, leaving it largely unregulated. CBD is a substance that has been researched many a time in order to prove its potential health benefits scientifically. Alongside this, seeing a GMP compliance certificate would instill confidence about the quality of a CBD product and its contents being exactly what is stated on the label.
Read on to find out why Good Manufacturing Practices matter and why you should check for the GMP certificate before making any CBD purchase.
What Is GMP?
Good Manufacturing Practices, or GMPs, are the regulations enforced in the US by the U.S. Food and Drug Administration (FDA). Canada, the EU, and many other countries have adopted the GMP guidelines set by the World Health Organization. The WHO and FDA regulations are largely similar, containing just a few differences.
GMP standards affect not only CBD products, but also cosmetics, pharmaceuticals, and veterinary products, along with medical devices and others. These practices are vital, especially when products could potentially harm consumer health when manufactured or used incorrectly. Therefore, it is hard to imagine the CBD industry were GMP practices to be neglected.
GMP standards demand CBD companies follow a certain set of rules to ensure product safety. Without them, consumers may be deceived or manipulated. To avoid adverse health consequences, regulatory measures are key – they ensure that products will not harm consumers’ health and wellbeing.
GMP in the CBD Industry
As the popularity spikes and demand from consumers grows, it becomes harder to control every CBD product. It is estimated that the CBD market will surpass a value of $56.2 billion by 2028. Thus, now is the perfect time to educate consumers about health effects and raise their awareness about health risks, too.
The FDA is aware of increasing popular demand and is working on introducing new effective policies to enforce in relation to the regulation of CBD products. The FDA is keen to signal that many companies currently market CBD products in a way that violates the Federal Food, Drug, and Cosmetic Act.
Until the FDA comes up with new regulations, it is up to CBD manufacturers to self-regulate under the GMP laws. Although not a mandatory step, having GMP certifications can be a reassuring stamp of approval for many consumers.
What Is the Difference Between GMP and cGMP CBD?
You might have encountered a similar term for the certification – cGMP (or CGMP). It stands for Current Good Manufacturing Practices. It is a similar quality protocol that gives more freedom to CBD companies, specifically when it comes to what devices to choose and what manufacturing process to employ. However, the emphasis is always on the current. This means whatever technique and devices are used, they should be up-to-date.
Therefore, the main difference between GMP and cGMP is that the Current Good Manufacturing Practice has the newest techniques and methods added to it that many CBD companies would be well-advised to utilize. Hence, the current prefix is added to the protocol.
Overall, both GMP and cGMP regulations ensure that manufacturing processes are up to standard for the sake of customer safety.
GMP Certified CBD as an Integral Part of the Cannabis Industry
GMP or cGMP compliance forbids companies to retail contaminated products and spread misleading marketing information about their offers to consumers. cGMP certification also confirms that a seller hasn’t mislabeled drug products but instead has specified the exact percentage of CBD in a product.
When purchasing any drug product, GMP compliance is also a good indicator that the manufacturing processes were carried out according to industry standards. This is because GMP involves strict practices, and any company following them is doing their best to prevent contamination, mix-ups, and human error during the manufacturing process.
Moreover, there is no one-for-all policy; GMP requirements are flexible so that manufacturers can individually decide what methods and techniques work for them the best. The only demand for all GMP-certified CBD manufacturers is to employ “scientifically sound design, processing methods, and testing procedures.”
What Are the Benefits of GMP Certification for Consumers?
GMP certification proves that companies follow industry standards from the very beginning. There are benefits for both companies and clients. CBD manufacturers can improve their online standing and earn trustworthiness and credibility in the eyes of their clients. As for the consumers, they won’t worry whether the labeling is correct and whether the contents are according to the description. Briefly, being GMP certified means a company:
- Controls manufacturing operations
- Properly tests batches of products
- Has valid records
- Has been meticulously inspected by FDA staff
Another interesting fact for consumers who have some doubts about cGMP compliance is that in order to receive the certificate, a company undergoes a long-term examination that can last up to a year. This means the investigation and inspection are not a short-time event but a thorough process.
Does CBD Need to Be Regulated?
This is a question that people could debate about for hours. CBD certainly has promising positive effects on health and has the potential to become an effective drug for a number of illnesses. Researchers are working hard on exploring the advantages of CBD, and by the time they scientifically prove anything, CBD companies shouldn’t have jeapordized the industry with false claims.
If you are a concerned consumer who worries about purchasing ineffective products, then it is best to look for GMP certification whenever possible.
How to Become GMP Compliant?
To be GMP compliant, your company needs to be inspected and tested by highly-qualified FDA staff. First of all, FDA experts test your product for any defects and errors. They would usually take a small amount from a batch of your finished products. Your manufacturing practices should also be aligned with the GMP regulations; otherwise, your CBD products will be considered adulterated. More about that later.
Secondly, they will look at the condition of your laboratory or other premises and whether the equipment there is maintained properly.
Thirdly, the FDA will look into your staff, their qualifications, and licenses. FDA staff will also make sure your employees are aware of and work according to the GMP standards.
Apart from checking your workplace and staff, the FDA will look at your reports and records too before making their final decision.
Overall, to receive a Good Manufacturing Practice certificate, the inspection will take into account:
- Reports (what raw materials you use, what methods you apply to carry out manufacturing, etc.)
- Staff and their qualifications
- Equipment and their calibration
- Condition of a laboratory
- Current manufacturing processes
Additionally, there is a general inspection that doesn’t specifically focus on the manufacturing process but on the management of your workplace. It inspects the following:
- Safety and security of the workplace
- Distribution of the responsibilities
- Product quality monitoring
This is only a brief description of the FDA inspection to determine whether your company can receive the GMP certification. Each category further expands and encompasses more regulations that should be enforced in your company. Although the list is extensive, FDA does all of it to guarantee the safety of consumers.
What Happens If You Are Not Following GMP Rules?
Before, we mentioned that if your procedures are not up to a certain standard, the FDA will mark your product as adulterated. Simply, it means the conditions set by FDA were not met. Note that it doesn’t necessarily mean your product is faulty. The circumstances can vary between businesses.
Rarely would the FDA tell you to stop producing the designated product, but certain suggestions would be proposed to be implemented in the future. In case the unapproved product is already available to consumers, the FDA would require you to recall the products from the shelf.
Vantage Hemp – Your GMP Certified CBD Manufacturer
Since a consumer lacks the equipment and knowledge to check hemp-based products for quality and accurate labelling, GMP regulations allow CBD companies to prove the quality and purity of a product. Vantage Hemp is no stranger to this – you can find our certifications for ICH Q7 and WHO Good Manufacturing Practices here. Our manufacturing processes are maintained to a very high standard at all times, from the beginning of planting and harvesting to the very end of developing the raw materials into the finished products.
Our hemp-derived products are manufactured under the GMP regulations to ensure purity, safety, and the highest quality for our clients. We offer CBD oil that is GMP certified, along with distillates and isolates.