All new industries experience some type of growing pains, and the cannabis business is no different. The marginalized reality of the industry has created uncertainty and leaves cultivars without GMP's or Good Manufacturing Practices to follow.
What are GMP and cGMPs?
In the United States, the Food and Drug Administration (FDA) produces GMP and cGMP (current good manufacturing practice) guidelines for crops. Still, it has yet to address the cannabis and hemp industry. Without guidance, quality guideline development in the US is bequeathed to business owners and state lawmakers.
The international cannabis market operates by a different set of rules. Australia regulates its cannabis industry with the Therapeutic Goods Administration (TGA), run by their Department of Health. Canada has regulatory agencies that oversee cannabis agriculture and distribution; the EU (European Union) relies on WHO (World Health Organization) to standardize GMPs.
GMP programs differ broadly from country to country. GMPs are utilized to prevent harm to end-users or patients. While following GMPs, product is safe, and the manufacturing and packaging processes are regularly documented.
Here's an overview of what the bulk of GMPs consist of:
Specific manufacturing methods are set, and processes are conclusive and repeatable.
Alterations to methods must be precisely documented.
Proper accounting must be prepared, including a complete batch history of manufacturing and distribution to the end-user.
Recall protocols must be outlined and made available.
All product complaints must be thoroughly investigated.
The WHO GACPs are problematic when applied to the cannabis industry. They explicitly point to plant medicine "grown in the wild," not cultivated in a greenhouse or indoors. Interpreting these guidelines within the definition of medical cannabis is incredibly confusing.
PIC/S (Pharmaceutical Inspection Co-operation Scheme) is a global association between regulatory authorities in GMPs of medicinal products for human consumption. While it seems like the most likely group to create a medicinal cannabis GMP, the official website does not have any policies related to any type of cannabis cultivation. In the absence of standardization for the thriving medical cannabis industry, businesses must create their own GMPs.
While some countries have accepted that cannabis is here to stay by creating official CMPs, a small percentage of territories have instituted good manufacturing practices, leaving patients and recreational users at risk. For the rest of the world, including the US, companies and local lawmakers will have to continue to step up to keep high-quality standards and keep end-users safe.