Good Manufacturing Practices (or, GMP) is a set of standards created by the US Food and Drug Administration to ensure products manufactured for consumption are safe and produced consistently and reliably to specifications for identity, strength, quality, and purity. While it may seem like GMP is essentially a Quality Management system, the standards are actually a systematic method of control throughout the entirety of an organization. The GMP system requires processes, procedures, and documentation across design/development, supplier management, procurement, manufacturing, facilities, material traceability, hiring and training, quality management and continuous improvement.
Essentially, GMP is creating documented processes that allow an organization to produce an item exactly to specification and the ability to communicate to suppliers and customers when a deviation occurs. And obtaining a GMP Certification establishes trust between trade partners (and ultimately the end consumer).
GMP standards were created in 1969 and have been a staple to the food and pharmaceutical industries for decades. Many retailers require GMP certification before approving a product for sale.
GMP in the Cannabis Industry
While, as of this writing, the regulation of cannabis is fragmented in the United States, pursuing GMP certification is an important consideration for organizations throughout the cannabis supply chain. Cannabis regulations are currently specific to individual states – but as the federal government moves closer to national legalization, it is safe to assume that the regulatory burden will shift from individual states to national standards. And, if that is the case, it is likely that the FDA will oversee the cannabis industry and roll cannabis into GMP standards.
Even if your organization is not currently pursuing GMP certification, it may be important to begin understanding the requirements and building a roadmap towards GMP compliance. This will ensure that, if/when federal legalization occurs, your organization is ahead of the curve and ready to pursue a certification.