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Navigating Cannabis GMP Certification: A Conversation with Kim Stuck

Kim Stuck discussing GMP certification for cannabis companies on the Qredible Broadcast.

We recently sat down with Kim Stuck of Allay Consulting to discuss Good Manufacturing Practices (GMP) for cannabis companies, the importance of compliance, and what you can do to stay ahead of changing regulations.

Read the transcript below or watch the video.

What is GMP Certification?

Qredible: Welcome to the Qredible Live Broadcast. I’m so excited to be here today and to introduce Kim Stuck, who is the CEO of LA Consulting, which is a compliance consulting firm that helps companies with many types of compliances but specializes in cGMP (current good manufacturing practices) and OSHA compliance. Welcome, Kim!

Kim: Thanks for having me!

Qredible: To kick things off, can you give us an overview of what GMP certification is, specifically in the CBD and cannabis space, and if there are any key differences?

Kim: The only real difference between hemp and THC cannabis is which certifying bodies will work with you. The actual certification process is the same. Many think they can’t get GMP certification if they have THC cannabis, but that’s a myth–we’ve been able to get it for a few years now.

GMP stands for good manufacturing practices and has existed for over 100 years. It’s a certification that looks at the processes in your facilities and evaluates them to ensure everything you’re producing is as safe as possible. It covers things like risk mitigation, consumer protection, and quality assurance to make sure customers are getting a consistent product every time.

Qredible: This is such an important topic because many CBD and cannabis products don’t follow the same stringent quality standards as food products, for example. As we look ahead to potential new FDA guidance, what are your recommendations for companies to future-proof and implement safe practices now?

Kim: We can look to regulations in other industries like supplements and food for guidance until we have cannabis-specific regulations. Following FDA guidelines, getting GMP certification from an accredited third party, and having food safety programs in place will put companies way ahead of the competition.

I think warning letters around claims will continue. Many don’t understand what constitutes a claim, so being mindful of branding and marketing is key. How products are made is also critical. Striving for GMP certification shows your company cares and is preparing for the future, even if it takes 1-2 years to fully implement. Ignoring GMP requirements means you’ll likely suffer when regulations come.

Is GMP Certification Expensive?

Qredible: As you said, many companies are struggling financially right now with things like 280E. Do you have any advice for how companies can work towards GMP certification in a phased, budget-conscious manner?

Kim: We work with companies of all sizes, from huge corporations to two-person teams. We can work on a sliding scale of hours per month based on your budget. Even doing one thing a month to become more compliant gets you one step closer. It’s better than nothing. The full GMP certification process takes at least 6 months, often longer, so working towards it slowly over time is sometimes the best approach.

Qredible: In terms of shaping regulations, what are some ways the industry can work proactively with regulatory bodies like the FDA? Are there any lessons we can learn from how Canada approached GMP regulations?

Kim: I’m part of several committees working on state and national cannabis regulations. Anyone can join groups like ASTM International that are developing standards the government references. Being involved, providing comments during public comment periods, and volunteering your expertise helps shape better regulations.

Following existing regulations like supplement GMPs and getting third-party GMP certification puts you in the right framework. We’re taking those regulations and molding them to fit cannabis. So being proactive on GMP readiness in your own company is key while also joining groups like ASTM to have a voice at the table.

How Does Technology Help with GMP?

Qredible: How do you see technology like track and trace systems helping with GMP compliance and documentation?

Kim: GMP requires huge amounts of documentation and record keeping. Tech tools can help tremendously with logging information, keeping accurate time stamps, and streamlining track and trace for ingredients and finished products. Some cannabis-specific software we work with handles common industry processes as part of GMP tracking. This makes staying compliant much easier than manual spreadsheets.

Qredible: For companies just starting out on this journey, what’s the best way to engage LA Consulting and get a GMP program off the ground?

Kim: Reach out on the Allay Consulting website and fill out the contact form. We’re happy to provide more info and discuss your specific needs. We can evaluate your operations, build an SOP program from scratch, and break the process into manageable pieces on a timeline and budget that works for you. 

Qredible: Excellent, thank you so much for sharing your insights today, Kim!

Kim: Thank you for having me!

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