It’s getting crowded out there for cannabis brands. From new product formulations to the public’s increasing enthusiasm for sustainable packaging, the pressure to innovate and differentiate is on brands and businesses up and down the cannabis supply chain. But as the industry inches closer to federal legalization, ambitious cannabis product manufacturers in particular are well advised to start adopting manufacturing standards already in effect for consumer packaged goods companies, namely current Good Manufacturing Practices (CGMPs).
Created and enforced by the Food and Drug Administration for food, drug, device and supplement manufacturing, “CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.” Further, “adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations,” according to the FDA website.
Cannabis product manufacturers who want to hold or expand their market share under a legalized federal system, where process and product standards are fundamental, should not wait for federal legalization to get started on implementing CGMP.
For edible and other cannabis-infused product manufacturers, that starts with adopting best practices in the kitchen and planning an infrastructure that supports CGMP standards across the supply chain.
Indeed, CGMP requires time, enterprise-wide commitment and significant investments. Here are four key CGMP-related considerations for any growth-oriented cannabis product manufacturer preparing for federal legalization.
- Focus on quality management. Robust quality management systems — or a lack thereof — can truly make or break a cannabis business working in today’s exceptionally complex and confusing regulatory environment, where quality standards are defined by each state.
A quality management system — or QMS, for short — includes documented standard operating procedures and processes across the organization, including human resources, procurement and manufacturing. This is a big task that takes time and coordination across multiple departments. Compliance directors are advised to be mindful of federal regulations.
- There are no short cuts. In any business, inferior or cheap materials, ingredients and equipment often lead to inferior results. Forward-focused cannabis businesses implementing CGMPs should be aware of the investments and costs involved to accomplish each process, and prioritize accordingly for their unique budget, goals and timing. This requires strategic decision-making related to ingredients, staffing, equipment and facilities to achieve enduring success post-federal legalization.
- Invest in cannabis compliance software. As the industry has grown, so too has sophistication in compliance software. Options for this essential investment range from off-the-shelf, cannabis-specific compliance management software suites to home-grown systems built by in-house IT teams. Regardless of which software a cannabis business chooses, these systems must, at a bare minimum, demonstrate to auditors a controlled system that shows a trail of who did what and when.
- Think strategically about accreditation bodies. It is important to understand the difference between certification and accreditation and the value of accreditation to your business strategy. Companies should plan ahead for product types and geographies, which is particularly important if international distribution is part of that strategy.
CGMPs may seem like a tremendous burden in terms of costs and operational complexity. However, today’s consumers expect products they ingest and bring into their homes to be safe. They are also increasingly aware of the supply chain and processing journeys that everyday products and foods go through, and they want assurance that they are making informed purchasing decisions.
Building on current quality management systems and facilities now will set kitchens and teams up for compliance and overall success in the long run. After all, if your facilities and production team can’t take the heat of compliance, it’s time to get out of the cannabis kitchen.
Orna Bresler is director of compliance at MariMed Inc., a Massachusetts-based multi-state cannabis operator with 17 licenses across six states. She has an MBA and Regulatory Affairs Certification. With more than 25 years of experience commercializing life science products in compliance with GMP/ISO quality standards and federal regulations, Bresler helps MariMed develop processes and standards that protect its teams and the consumers of its wide variety of cannabis products. She is also a member of the National Cannabis industry Association’s Packaging and Labeling Committee.