Have you heard of GMP? It’s coming! We’ll break it down for you.
You’re likely familiar and the acronym stands for: Good Manufacturing Practice.
With GMP compliance, it’s only a matter of “when” these regulations will be required, especially given the lucrative European markets and potential FDA regulations on US markets.
Now is the time to look at what your company is doing to prepare for GMP compliance.
We enjoyed our informational webinar with Greg Jones, of GMP Collective.
He shared his wisdom and ideas about GMPs – what they are and what they are not.
Here are some of Greg’s suggestions and how to start implementing GMPs.
What Are GMPs and What They Are Not?
- Because of State to State legislation, each state is responsible for their own set of regulations. As anyone attempting to market and sell cannabis in different states knows, there are subtle and outright differences between each state and how the rules are written and interpreted.
- What makes it more difficult, is that each state depends on different agencies for support in regulating. For example, as cannabis is regulated in CO, the Marijuana Enforcement Division (MED) regs do not go into detail about food safety, that falls on the Colorado Department of Public Health and Environment (CDPHE) . Pesticides belong to both entities, but rely on the Colorado Department of Agriculture (CDA) for advice on pesticides. The EPA can’t comment outright, because they are a federally regulated entity. It is easy to see the disconnects and difficulty to understand, let alone navigate.
- We have a pretty good idea that cannabis will be federally regulated soon. When that happens, a lot of this will be sorted out, the science of all this will have a strong voice and the FDA will have investigative and enforcement powers with much more reach than currently in place state to state.
- Preparing for this next wave of regulations is to be educated and ahead of the curve. First, understand what GMPs are and aren’t and build your plans, execution and culture around that. Understanding and following GMPs will help you understand your suppliers, your defined processes and product definition specifications, quality and safety. Basically, in the paraphrased words of the FDA, GMPs help you bring products that are “safe, pure and effective” to the market. They help you see how to assure quality is part of every step of your company’s process, from sourcing your vendors and their assurance of quality materials, the storage and transportation to and from your facility to maintain quality, the packaging and labeling, testing, identified hazards and your steps to mitigate risk, etc.
- Why are CGMPs so important? (Current Good Manufacturing Practices) A consumer usually cannot detect (through smell, touch, or sight) that a product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances, testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products. We stress the importance of training for the whole team.
- If a manufacturer is not following CGMPs, are drug products safe for use? If a company is not complying with CGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It does not mean that there is necessarily something wrong with the product.
- Curious about what GMPs aren’t? They aren’t finances, human resources, business contracts, your customers, etc. GMPs do not require reporting costs, but in the interest of staying in business a company needs to know its costs or they wouldn’t know if they are making a profit and can reinvest in itself. Once you know your steps and costs of goods and equipment, it is easy to overlay the costs to the processes. Take that a step further and look at how you develop a new product to launch. How do you know your suppliers are providing what you agreed to purchase; every time? You should have an agreement in place that gives specifications and what to do if specs are not met. Guess what, this gets into GMPs in referencing supply chain.
- How do you see GMPs benefiting the industry or individual companies? Step back and take a look from 30,000 feet. Do you know what your product is, how it is manufactured, environmental conditions, recipe followed (batch record), storage conditions, tested? All these facets are GMPs. Wouldn’t it be nice to know, with assurance, your product and process work? To know if it fails a test, you have information to go back and look at different steps, instead of shot gunning a fix? But the most fun is having the information to determine if you can make your process better and more efficiently. Or have the wherewithal to create new products.
- Where do we go from here? Greg Jones is on 2 committees (ASTM international) and CDPHE (Colorado) that are reviewing current regulations and comparing and proposing new standards exclusively for the cannabis industry. Comparison documents are Canadian GMPs, EU GMPs, ISO standards, ICH standards and FDA GMPs and other existing standards. They are not trying to reinvent the wheel, but you have to agree, this versatile little plant provides so many options, that it is a challenge to be all encompassing under one existing standard. It is a botanical, it is an oil, an edible and inhalable. It has CBD and THC properties. Another big challenge is the need for more scientific research that is needed to make safe decisions. This requires knowledge, trending and risk assessment, all part of any good GMP program.
Once ownership understands how to have GMPs working for them, they can better protect themselves from frivolous lawsuits about product safety, because if they have the procedures and documentation, they can better defend themselves and create process improvements to save money through better efficiencies.
To reach Greg Jones, at The GMP Collective, for questions or a consult:
Training is a basic foundation of GMPs
Our Sell-SMaRT™ Responsible Vendor Compliance Training class is ideal for dispensary workers (from owners, managers, to all front end staff)
Our ServSafe® Food Handler class is ideal for manufacturers of cannabis infused products.
It meets the state requirement for food safety in several states. Questions about our classes: firstname.lastname@example.org