The GMP Collective team kicked off 2023 with a webinar discussing the major cannabis industry pain points that the media captured in 2022. Further, we dove into a number of simple and proven solutions – tools every operator should have in their toolbox – that will position operators for continued market challenges in 2023. Read on for a recap!
With all the recent negative headlines, including lack of trust in cannabis labels, inaccurate test results, and market decline andconsolidation, how do we move forward as an industry? We discussed that some of the industry is motivated by “get rich quick” schemes, which we recognize is not sustainable. Also, too often we play the blame game when something goes wrong, “it’s the regulators fault” or “it’s the lab’s fault.” Quality cannot be baked into final products, therefore we must be proactive to understand our processes and their inherent risks to control for those risks. It is time to shift to long-term goals that put quality and safety at the forefront, namely the development and implementation of standards (e.g., GMP).
So, how do we do this? The panelists offered ways to start making an impact on your quality management systems this year.
· Join standards development organizations, such as ASTM International, to have a seat at the table in creating the standards wewill be required to follow in the future. With FDA’s recent announcements indicating the food and dietary supplement regulatory frameworks will not workfor CBD products, it is likely they will look to industry to create standards that they will use to regulate our industry, as they have done with severalother industries before us.
· Get familiar with a GMP standard. Even though there are several different standards – 21 CFR Parts 111, 117, and 211 and ISO 9001 to name a few – they all have the same overarching themes, so start with one of them. Those same themes will likely exist in whatever regulatory framework we end up with.
· Use the internet to find guides, templates, “how to” videos, and cheap training on quality and safety topics. There are several resources already at our disposal.
· Establish a culture of quality, starting with top management. Top management must clearly establish quality and safetyrequirements and train staff so they understand what behaviors are expected of them. Also, educate staff on why you are doing the things you are doing.
· Set up frequent and open communication lines between top management and staff. Survey employees for their suggestions and take them seriously. Post quality data around your facility or send this information out in email newsletters regularly so the entire company is involved and have educated discussions.
· Start hiring a quality unit. Our industry is the only industry making consumable products that solely use third partytesting labs to evaluate and monitor quality rather than having dedicated quality individuals on staff.
· Use a risk mentality. Perform risk assessments and hazard analyses. Ask questions about the possible risks being introduced by suppliers, facility, equipment, processes, and people and implement preventive controls. For example, if Aspergillus is showing up in your final product, could it have been introduced by a raw material or input into your process? Test it and find out!
· Be legally defensible by having documentation and keeping good records. You can’t just say you did something; it must be documented.
· Partner with a third-party lab, consultant, and/or GMP certification body that can come to your facility and give you an outsider’s perspective on where you are at today and make suggestions on how you can improve in the future.
· Start a mini-internal lab with microbiology and HPLC capabilities to start testing along your process – not just testing final product.
· Implement a “caught you doing something right ”program to celebrate when people are putting quality and safety first.
Have questions or still not sure where to start? Drop us a line at firstname.lastname@example.org and let us connect you with one of our experts.
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