Allay Consulting’s July Newsletter: State Required Cannabis cGMP Certification

State Required Cannabis cGMP Certification

Say it isn’t so, some states are requiring certifications for cannabis companies! Not only are cGMP certifications gaining momentum within the THC and hemp industry, but more states are also requiring cGMP certification and other related quality management certifications. These related quality management certifications include cGMP and HACCP for product manufacturers, GACP for cultivation, 111 for dietary supplements, and 210 for pharmaceutical.

These certifications help companies with liability reduction, product consistency, risk mitigation, gaining a competitive edge, and regulatory readiness. Not only do these certifications help businesses limit hazards related to contamination and process controls risks, but also ensures that products are consistent and safe for consumers which is why we are seeing more states requiring these quality management certifications.

States Requiring Quality Management Certifications for Cannabis Licensees

Just a handful of states are requiring these certifications for their cannabis licensees. States requiring certification include Michigan (GACP immature plant sales & cGMP/HACCP for infused beverages), New York (hemp manufacturer selling dietary supplements cGMP), Florida (cGMP), and Maryland (cGMP, 111, 210). Allay Consulting highly recommends, some states even require, that all certifications are from accredited certifying company. We are hearing more chit-chat from other states who are potentially requiring these certifications; we will keep you in the loop as those requirements change!

States Offering Incentives to Receive Quality Management Certifications

Michigan Cannabis Regulatory Agency (includes both THC cannabis & hemp) offers sampling/testing reduction as an incentive when licensees receive either GACP for cultivation licensees and the cGMP for manufacturing licensees. Note that Michigan requires GACP for licenses who sell immature plants and cGMP for licenses who manufacture infused beverages, but Michigan also offers incentives for licensees who fall in and out of these categories.

States with cGMP Aspects Built into their Regulations

The leading states that include quality management systems built into their regulations are California and New Jersey. California’s Department of Cannabis Control has a decent sized “Good Manufacturing Practices” section under manufacturing. These states have plenty of quality management requirements that are required by both GACP and cGMP standards. Some of these requirements include expectations of exterior and interior maintenance, plumbing system, sanitation, cross contamination, equipment and utensil requirements, personnel procedures, manufacturing processes, employee training, and more. By including quality and safety requirements within regulations, these states are trying to promote product safety!!

Big Box Retailers Requiring cGMP Certifications

Large box stores like Walmart, Target, CVS, Walgreens, Amazon, etc. require cGMP certifications for all consumable products sold at their establishment. This helps reduce their own liability. Simply having the cGMP certification allows hemp companies (hopefully THC companies in the future!) to sell from these big box stores. Even if companies do not require cGMP certification, some companies like PetSmart have Code of Conduct Agreements that their suppliers operate within current good manufacturing practices. It is not uncommon for these large companies to perform quality and safety audits at their supplier’s facility. Putting in the work to obtain cGMP certification certainly pays off, especially if you want to sell at large big box stores.

It seems more and more states are either requiring or incentivizing cannabis cultivation & manufacturing companies to receive certifications from accredited companies. This might be trendy now, but if cannabis regulations are aligning with the FDA’s requirements surrounding quality and safety, obtaining certification is one easy way to ensure you’re in compliance when FDA regulation begins. Even if your state doesn’t require or incentivize certification, the long-term success of your business should focus on the safety and quality of your products. If this trend attracts more states, are you preparing for certification?

Need Support with cGMP Implementation?

Preventing nonconformances not only reduces your chance of receiving a nonconformance report, but more importantly protects your company from liability issues. Prevention is key to compliance success. We hope sharing our common cGMP nonconformances provides useful insight and an opportunity to learn from our experience. Allay Consulting compliance services work one-on-one with your company to create a realistic Quality Management System that is unique to your company’s production needs.

Contact Allay Consulting to learn more about implementing a cGMP system, written documentation, facility compliance, certification readiness, and employee education!

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