Despite the rapid development of the cannabis industry, safe production methods remain unclear. The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have imposed significant restrictions on cannabis product operators to stay on the right side of the law. Cannabis and marijuana producers are thus left to fend for themselves or have chosen to ignore existing guidelines because the lack of federal oversight allows them to do so. Inconsistent regulations governing the production, packaging, labeling, and testing of cannabis products can lead to unsubstantiated, unscientific, and often downright false claims about the safety and efficacy of cannabis products.
Science versus law
Hemp and marijuana are both species of the cannabis family, the Cannabaceae. They are genetically identical, but are randomly defined by the presence of delta-9-tetrahydrocannabinol (THC). While science does not distinguish between cannabis and marijuana, the law does.
The cannabis industry announced a small victory with the passage of the 2014 Farm Bill. The bill allows state universities and agriculture departments to grow cannabis under state law. Moreover, industrial hemp is officially defined by setting the legal limit for THC at 0.3% of dry weight. The 2018 Farm Bill, led by the USDA, took further action by allowing hemp cultivation and removing hemp seeds and grains from the CSA. However, the bill does not include a provision for the safe manufacture of cannabis-based consumer products. The 2018 version also retains FDA’s authority to regulate products containing cannabis and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act). To everyone’s surprise, the bill continues to make it illegal to list cannabidiol (CBD), also derived from cannabis, as an ingredient on consumer product labels. Moreover, manufacturers of CBD products are not protected by current regulations. Since 2015, the FDA has sent warning letters to companies marketing CBD products as dietary supplements and/or edibles, and in December 2018, the FDA declared it illegal to market CBD (or THC)-containing edibles in interstate commerce, whether or not they are made from cannabis. To date, Epidiolex from GW Pharmaceutical is the only CBD product approved by the FDA.
Marijuana remains classified as a Schedule I controlled substance under the CSA. Thirty-six (36) states have approved comprehensive, publicly accessible medical marijuana programs, and currently 14 states have approved marijuana programs for adults, of which New Jersey has approved 22. February 2021 a law passed. However, there has been little movement in the marijuana industry toward mandatory GMP compliance. Few medical programs require manufacturers to adhere to GMP. Moreover, the regulations are contradictory and the wording of the regulations on how to implement the RAP is vague and inconsistent. This inconsistent evidence confirms the complexity and difficulty of implementing a consistent, standardized, and robust approach to safe manufacturing practices.
What is GMP and why should you care?
Good Manufacturing Practice (GMP) is a system that ensures consistent production and control of products in accordance with quality standards and regulations. Implementing a GMP program ensures consumer health and safety, enables manufacturers to understand the purpose of their products, allows manufacturers to protect product specifications where necessary, addresses risks to vulnerable populations, and minimizes overall business risk. In short, GMP stands for product safety and quality and defines a manufacturer’s responsibility to protect consumers from the distribution of unsafe and ineffective products. The GMP landscape in the cannabis sector is currently complex. The different variants of GMP (food, food supplements, cosmetics and medicines/devices) cause confusion and frustration for many people when they decide to apply GMP. Confusion arises from the lack of clarity in legal requirements and the fact that operators do not fully understand how to classify or label the end use of their products. The implementation of an effective GMP programme requires good planning (both short and long term), financial commitment and competent resources.
Where do I start?
As the regulatory landscape of the cannabis industry continues to evolve and mature, your business model must consider GMP implementation if you want to remain successful and sustainable.
Intended use
Before applying a GMP, you should understand which GMP rules apply to the intended use of your product(s). Do you make food, beverages or dietary supplements? Read the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) on GMP.
Conducting a gap analysis
The gap assessment reveals GMP deficiencies. The assessment should include facility design, equipment design, supply chain, risk management and staff training.
Develop an action plan
Once the gap assessment has been completed, a comprehensive action plan will be drawn up, outlining the steps required to achieve GMP compliance. The action plan should follow the principles of SMART objectives:
- Sspecific (simple, clearly defined)
- Measurable (significant)
- Achievable (achievable, tolerable)
- Appropriate (means-based, reasonable and realistic)
- Punctual (on time, after a certain delay).
The plan shall include priority deliverables, timelines and allocated resources for strategic planning, implementation and completion of required tasks.
GMPSimulation test plan
The blank inspection confirms that the action plan has been properly implemented. Have the inspection performed by an experienced person who is familiar with the relevant GMP and QMS. A successful simulation test is the perfect litmus test if the ultimate goal is GMP certification.
Cannabis producers who ignore the clear trend toward an FDA-like industry will not survive the game in the long run. Those who embrace this dynamic and plan appropriately to mitigate product and business risk – those who demonstrate integrity and are genuinely committed to delivering safe, effective and high-quality products to consumers – will lead the way, earn trust and build brand awareness.
References:
- 21 CFR Part 111, Current Good Manufacturing Practices in the Production, Packaging, Labeling, or Storage Operations of Dietary Supplements.
- 21 CFR Part 117, Current Good Manufacturing Practices, Risk Analysis and Risk-Based Preventive Controls for Human Foods, and the Food Safety Modernization Act (FSMA).
- 21 CFR Part 210, Current Good Manufacturing Practices in the Manufacture, Processing, Packaging, or Storage of Drugs; General Provisions.
- 21 CFR Part 211, Current Good Manufacturing Practices for Prepackaged Drug Products.
- 21 CFR Part 700, Subpart G – Cosmetics.
- 21 CFR Part 820, Subpart H – Medical Devices; Quality System Regulations
- Congressional Research Service, Food and Drug Administration (FDA), 12. June 2019.
- U.S. Food and Drug Administration warning letters, current content as of 19/21.
References:
frequently asked questions
What is a GMP in the food industry?
Current food preparation practices (GMPs) are published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). GMPs describe the methods, equipment, facilities and controls for the production of processed food. … GMP is also one of the bases for FDA inspections.
What are the 5 key elements of good manufacturing practices?
To achieve this, GMP helps ensure consistent product quality and safety by focusing on five key elements, often called the 5 Ps of GMP: people, facilities, processes, products and procedures (or paperwork).
Are GMPs required by law?
In the United States, there are no federal laws requiring food packaging manufacturers to be GMP-certified, but manufacturers of food contact materials must comply with food packaging GMP requirements The general indirect food additive regulations contained in Title 21 of the Federal Code of Federal …
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