GMPs & Hashish Manufacturing | Hashish Trade Journal

Editor’s Note: While CIJ typically omits the word “marijuana” due to outdated nomenclature and adverse connotations, we understand that the legal distinction between cannabis containing THC and hemp requires the word to be used when referring to federal government policy and the legislative language is referenced.

Despite the rapid development of the cannabis industry, ensuring safe manufacturing practices remains unclear. Both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have placed significant hurdles on cannabis operators in staying on the “right side” of the law. “Hence, the makers of hemp and marijuana products had to do things find out for yourself or ignore existing guidelines, as they can do this due to the lack of supervision by the federal government. Inconsistent regulation in the manufacture, packaging, labeling and testing of cannabis products offers the potential for unfounded, non-scientific and often obviously incorrect statements about product safety and – effectiveness.

Science versus law

Hemp and marijuana are both types of the Cannabaceae cannabis family. Genetically, they are identical but are arbitrarily defined by the presence of delta-9-tetrahydrocannabinol (THC). While science doesn’t differentiate between hemp and marijuana, the law does.

The hemp industry declared a small victory with the passage of the Agricultural Law of 2014 (Farm Bill 2014). According to this law, universities and state agricultural departments were allowed to grow hemp under state law. In addition, “industrial hemp” was officially defined by setting the legal limit for THC at 0.3% based on dry weight. The Agricultural Improvement Act of 2018 (2018 Farm Bill), under the guidance of the U.S. Department of Agriculture (USDA), went a few steps further by authorizing the cultivation of hemp and removing hemp and hemp seeds from the CSA. However, the bill does not contain any language mandating the safe manufacture of consumer goods from hemp. The 2018 version also retained the FDA’s power to regulate products containing cannabis and cannabis-derived compounds under the Federal Food, Drugs, and Cosmetics Act (FD&C Act). To the surprise of most, the listing of cannabidiol (CBD), even made from hemp, as an ingredient on consumer product labels remains illegal. In addition, CBD product manufacturers are not protected under applicable regulations. Since 2015, the FDA has issued warning letters to companies that market CBD products as dietary supplements and / or foods. In December 2018, the FDA made it illegal to introduce CBD-containing foods (or THC) into international trade, regardless of whether they were made from hemp. So far, GW Pharmaceutical’s Epidiolex is the only FDA-cleared CBD product.

Marijuana remains a Schedule I Controlled Substance under the CSA. Thirty-six (36) states have approved comprehensive, publicly available medical marijuana programs, and now 14 states have approved programs for adult use, with New Jersey passing legislation on February 22, 2021. However, minimal steps have been taken in the industry to meet GMP requirements in the marijuana market. Manufacturers only need to follow GMP for a handful of medical programs. In addition, the interstate and language requirements in the rules on how to implement GMP are vague and incoherent. These fragmented guidelines add to the complexity and difficulty of enforcing a coherent, standardized, and reliable approach to safe manufacturing practices.

What is GMP and why should you care?

Good Manufacturing Practices (GMPs) are a system that ensures that products are consistently manufactured and controlled in accordance with quality standards and government guidelines. Implementing a GMP-compliant program ensures the health and safety of consumers, enables manufacturers to understand the intended use of their products, enables manufacturers to defend product specifications as appropriate, takes into account the risks to vulnerable populations, and minimizes overall business risk. In short, GMP equates to product safety and quality and defines the manufacturer’s responsibilities to ensure that consumers are protected from the distribution of unsafe and ineffective products. Currently, the GMP “landscape” in the cannabis space is complicated. The various “flavors” (foods, supplements, cosmetics, and medicines / devices) of GMP leave many confused and frustrated when they choose to implement GMP. Confusion is the result of unclear regulatory requirements and the fact that operators do not fully understand how to classify or label the end use of their products. Implementing an effective GMP program requires adequate planning (both short and long term), financial commitment, and skilled resources.

Where should you start

As the regulatory landscape in the cannabis space evolves and matures, your business model must take into account the implementation of GMP if you are to remain successful and sustainable.

Usage

Before you can implement GMP, you must first understand what GMP regulations apply to the intended use of your products. Do you make food, beverages or supplements? Familiarize yourself with the FDA Code of Federal Regulations (CFRs) for GMP.

Perform a gap assessment

You can use a gap assessment to identify your GMP compliance deficiencies. The assessment should include plant design, equipment design, supply chain, risk management and employee training, among other things.

Develop a plan of action

Once the gap assessment is complete, a comprehensive plan of action will be developed to identify the steps required to achieve GMP compliance. The action plan should follow the principles of the SMART goal:

  • Specific (simple, well defined)
  • M.simple (meaningful)
  • ONreachable (reachable, agreed)
  • R.Elegance (resource based, sensible and realistic)
  • T.imely (time-based, defined due dates)

The plan includes prioritized results, due dates, and allocated resources to strategically plan, execute, and complete the required tasks.

Schedule a bogus GMP inspection

A mock inspection confirms that the action plan has been carried out properly. Hire a skilled resource who is familiar with related GMPs and QMS to conduct the inspection. A successful mock inspection is a perfect litmus test if the end goal is to achieve GMP certification.

Cannabis makers who ignore the obvious advancement towards an FDA-like industry will not survive the long game. Those who use the momentum and plan properly to mitigate product and business risk – those who demonstrate integrity and are genuinely in the realm of ensuring consumers safe, effective and high quality products will have the edge, Gain credibility and secure brand awareness.

References:

  • 21 CFR Part 111, Current Good Manufacturing Practice in the manufacture, packaging, labeling or storage of dietary supplements.
  • 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food and the Food Safety Modernization Act (FSMA).
  • 21 CFR Part 210, Current Good Manufacturing Practice in the manufacture, processing, packaging or storage of pharmaceuticals; General.
  • 21 CFR Part 211, Current Good Manufacturing Practice for Finished Medicinal Products.
  • 21 CFR Part 700, subsection G-Cosmetics.
  • 21 CFR Part 820, subchapter H medical devices; Regulation on the quality system
  • Congressional Research Service, FDA Regulation for Cannabidiol (CBD) Products, June 12, 2019.
  • Warning letters from the US Food and Drug Administration, current content from February 19, 2021.

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