By Over the past century, a number of important concepts have emerged that are shaping the direction of society and improving our collective well-being. Among them, Good Manufacturing Practice (GMP) stands out as an indicator that guarantees product safety and consumer protection. Until GMP was established, industries such as pharmaceuticals operated in a state of limbo where products containing undisclosed and potentially harmful ingredients were peddled from wheeled carts as “miracle cure-alls.” Ta. Labeling requirements were lax, manufacturing methods were shrouded in mystery, side effects were unknown, and the true efficacy of these preparations was questioned.
Here in the United States, the lack of GMP has led to several serious incidents over the years with devastating consequences. Inadequate safety controls in the production of foods, drugs, supplements, and medical devices have led to thousands of deaths and other medical problems. In 1938, 30 years after the Pure Drug Act, Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA), formally establishing FDA's authority to protect the public health.
take 'snake oilFor example, a term associated with deceptive practices or fraudulent schemes. The original Chinese concoction was made using Chinese water snake oil, which helps relieve muscle pain and inflammation.when american salesman Once they had the recipe, they tried using rattlesnake oil, which does not have the same properties as Chinese water snakes. By the time the recipe was tested, it was found to contain alcohol and opium, but no real snake oil. This illustrates the dangers of unregulated products and the importance of standards such as his GMP in ensuring product integrity and consumer safety. Without proper oversight, consumers are vulnerable to misleading labeling and potentially harmful substances, highlighting the need for rigorous manufacturing practices in all industries, including cannabis.
Looking back at some examples in history where tragedies have occurred, contaminated and misbranded food and drugs caused widespread illness and death until basic standards for product safety and labeling were established. It can be traced back to 1906. Speaking of the end of the century, if you haven't read Upton Sinclair's The Jungle yet, add it to your reading list. This is one of the most influential books in American history, detailing the unsanitary conditions of the pre-GMP meat industry and leading Congress to pass some of the first food safety laws. He is directly responsible for this.
Some of you may remember the 1982 incident in which seven people died after ingesting cyanide-laced Tylenol capsules. This has introduced new industry standards, such as tamper-evident packaging and enhanced safety measures for over-the-counter medicines.
Even in modern times, recalls of contaminated meat and produce are a stark reminder of the continued importance of strict safety measures. These recalled foods not only pose serious health risks, but also result in significant economic losses and damage to the brand reputation of the companies involved. To further emphasize the importance of these safety measures, in 1994 Congress authorized the FDA to implement them. GMP guidelines for dietary supplements Through DSHEA (Dietary Supplement Health Education Act). However, his GMP guidance for dietary supplements was not published until 2007.
“There are many examples of safety issues that result from failure to implement GMP practices. Many food recalls and FDA warning letters are related to pest control, worker hygiene, cleaning and sanitation, employee practices, and other GMP practices. We’re reporting the problem,” says Dr. Steve Gendel, food safety expert and consultant with the GMP Collective. (Mr. Gendel also serves as the technical representative for the cannabis GMP standard recently voted on by ASTM.) “One example of the problems caused by inadequate GMP is that the Family Dollar Store pled guilty to a federal felony charge of 41 It was recently announced that customers who fail to exterminate rodents in warehouses will be fined 1 million yen. This follows a major recall of hundreds of products that passed through its warehouses. ”
In addition to criminal charges and hefty fines, brands that fail to maintain standard levels of safety and hygiene pose no risk to both customers and employees. It can also negatively impact your public reputation in the long run and create a public relations nightmare.in Rootworks' blog Dr. Kathy Knutson, another food safety expert and consultant to the GMP Collective, wrote in August 2023, “It’s all about the consumer.” Regulatory actions such as fines and recalls may be taken. In the food industry, the average cost of a recall is $10 million. ” For cannabis products, the most common types of recalls include contamination of products with aspergillus, salmonella, mold, heavy metals, and certain pesticides.
Antoinette Duncan, Director of Quality at Green Thumb Industries, shared several key examples of the lack of proper GMP in cannabis. “We had a situation at one site where we brought gummy material from one batch to another and we were not getting potency results. The previous batch contained trace amounts of cannabinoids, but the next The entire batch of gummies had to be discarded because unintended trace cannabinoids then showed up in the final test results. This was due to line clearance and pre- and post-operation A perfect example of why checklists are important. Another example is when mouse droppings are found in a product. It was unclear how many batches had been exposed to mice, so a large batch was Ensuring proper seals around doors and a strong pest control program (both part of a GMP program) can prevent unnecessary product loss.”
Once relegated to the shadows of illegality, the cannabis industry is now emerging as a legal market. However, as momentum grows, they face many challenges, including the imperative of ensuring product safety, consistency, and regulatory compliance. Adopting and complying with GMP is essential for the industry to establish market confidence, protect consumer health, and thrive in a competitive environment. “The California Cannabis Commission lists 13 recalls involving cannabis products from January 2022 to February 2024, nine of which could have been controlled through GMP and/or good cultivation practices. It was related to an issue,” Gendel added.
Although there are currently no national requirements for good manufacturing practices in the cannabis industry, more than a dozen states currently require some form of GMP for cannabis businesses, and for good reason. When implemented effectively, GMP can be beneficial to both businesses and consumers. These reduce the risk of costly product failures and recalls. They provide employees with the tools and guidance they need to perform their jobs safely and efficiently. Whether it's preventing mold and pests with an effective sanitation program or verifying that purchased equipment works as intended, day-to-day GMP is just good practice and a must-have for business owners. It is the absolute bare minimum that consumers should demand from business operations as well.
“Risk management is something that I, and probably many other quality leaders in the cannabis industry, struggle with,” Duncan says. “How far do we go? How strict do we need to be? Do we need to meet food requirements? Pharmaceutical requirements? Dietary supplements? All of us in cannabis are building an airplane and flying it at the same time. Therefore, risk plays a big role in decision-making. In general, a basic GMP program is absolutely necessary to protect consumers. However, the need to take an ATP swab every time chocolate is made Do we need to test the air for environmental pathogens? I think the jury is still out on some of these things. , it is important to have a strong quality management system (QMS) in place to implement CAPA to prevent problems from recurring. Based on the data and the level of risk, I will decide what actions to take and what They tend to decide if a program is needed.”
The potential risks to human health are not limited to cannabis products. Vaporizers and other related devices are important aspects of safety to consider. As the cannabis industry moves from illegal to legal, ensuring product safety, consistency, and regulatory compliance will be paramount. GMP implementation is essential to establishing market confidence, protecting consumer health, and thriving in a competitive environment.
From the spices and herbs in your kitchen, to the medicines in your medicine cabinet, to the food in your refrigerator, GMP is a global food and beverage product that has helped feed, nourish and protect nearly 8 billion people on Earth Recognized as a minimum best practice. our star. In conclusion, the importance of GMP extends across all industries and protects consumers and businesses alike. The adoption of GMPs by the cannabis industry demonstrates a commitment to excellence and highlights the important role these practices play in fostering a safe and reputable market now and in the future.
