GMP for the Cannabis Industry

GMP-logoCurrent cannabis regulations attempt to protect public health and safety by controlling for quality in a reactive manner, through testing. FOCUS standards provide comprehensive Good Manufacturing Practice guidelines for key areas of the cannabis industry, including: cultivation, retail/dispensary, extraction, infused products, laboratory, security, packaging/labeling, and business and environmental sustainability.

According to the World Health Organization, Good Manufacturing Processes (GMP) is a system for ensuring that products are consistently produced according to quality standards. 

GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process.

A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.

GMP involves much more than most people think.  A common misconception is that GMP only covers the process of manufacturing itself.

GMP actually covers all aspects of the production process

  • Materials
  • Premises
  • Equipment
  • Storage
  • Record Keeping
  • Staff Training
  • Hygiene
  • How Complaints Are Handled
  • Product Development

In most industries, agencies that control licensing for the manufacture and sale of a product recommend Good Manufacturing Practices (GMP), or guidelines to business owners. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. The guidelines generally become the basis of regulation for that industry.

In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related. However, because cannabis remains illegal at the national level, none of the federal agencies that would normally develop Good Manufacturing Practice guidelines have done so. Forcing state lawmakers and business owners to navigate this new, rapidly developing industry without uniform guidance.

This has resulted in US cannabis regulations that attempt to control for product quality being done solely through the mandate of laboratory testing.

While testing is an important part of any quality management program, it is only one aspect of quality control. Testing is a reactive process, leaving multiple opportunities for unsafe product to reach the market.  Quality control through testing alone also has the potential to dramatically drive up costs, which can be catastrophic to small business owners.

To be clear, FOCUS does not promote reduced testing, we are working towards sensible regulations and reduced testing failures by building quality and safety into the process and the products.

The comprehensive implementation of cannabis specific Good Manufacturing Practices, such as the FOCUS standards, across all aspects of the industry will assist business owners and regulators alike in addressing quality proactively, at every step in the process. This is critical to protecting consumer safety and public heath – and the overall success of a nascent industry like cannabis.