By Asa Waldstein
This is the first article in a three-part Compliance Essentials for Hemp-CBD Companies series. I explore commonly overlooked manufacturing, labeling, and marketing essentials ingestible cannabinoid companies need to be compliant. My first segment focuses on manufacturing.
With a lack of clarity happening at the federal level, my advice for hemp cannabinoid companies is to act like they want to be regulated, which is a dietary supplement in the case of ingestible products. These are CFR 111 or cGMPs for supplements.
Here are some essentials for Hemp-CBD manufacturers.
Establishing and documenting specifications. This is the most common violation and one of the easiest to follow. Specifications should be reviewed by Quality and then approved, rejected, or quarantined. This allows potential problems to be identified before items are used in manufacturing or released to the public.
- Packaging Components: Anything that touches the product should have a specification, including lids, droppers, bottles, and cotton. Components should be food grade and be issued an internal part number, internal lot number, and these should be correlated with the vendor’s item number and lot numbers.
- Labels: Label specifications should include the label size, internal part numbers, internal lot numbers, and line items. In March, we will talk more about labels in the next compliance essentials segment.
- Raw materials and finished products: You are getting the picture that everything should have a specification. This includes all product ingredients, and of course, the product itself needs written specifications. For example, if the product specification was a green, herbaceous free-flowing powder and the ingredient/product was clumpy and yellow, this would signify that the product is out of specification and should be rejected or quarantined for further investigation.
Checked and Verified-By System. This is just like it sounds. One person checks a number, such as an ingredient weight in a blend, and the other person verifies this. This should be completed simultaneously, creating complexity for small one-person manufacturing companies.
Documentation is a core principle of GMPs, and the mantra If it’s not written down, it didn’t happen is essential to keep in mind. Under GMPs, companies are required to destroy their old labels. I once saw a company completing this task; however, they were not documenting the label destruction. This could have been a 483 violation simply because of the lack of documentation. Learn more about the difference between FDA 483s and warning letters here.
Operational efficiency and GMP compliance go hand in hand to create a successful business. My advice is to develop a Quality Management System (QMS) with the individual company needs in mind. GMPs are a framework of regulations, but they leave a lot of room for interpretation. This is one reason I suggest hiring dietary supplement experts whenever possible, as they understand the nuances of interpreting GMPs to make sense for the individual company. For example, interpretations look different between a $1M supplement company and a $20M supplement company, and these regulatory interpretations look different than a pharma company. Having a properly functioning QMS is essential, but an overburdensome approach to Quality is restrictive. I see hemp companies hire exquisite pharmaceutical managers to develop their QMS. They get what they pay for, a rock-solid system that is pharma-level, but is this needed in a current small to midsize cannabinoid company? It doesn’t usually make sense and often raises costs, lead times, and complexities that unnecessarily hinder company growth.
Interpreting the regulations: There is lots of room for interpretation, and it’s hard to know how to implement them in a way that makes sense for your company. Here is one example of how two cGMP approaches get the same outcome.
Scenario discussion: GMP regulations state Design manufacturing processes to ensure product specifications are consistently met. This aspect of the regulations leaves room for interpretation, but the goal is to ensure the products are manufactured within specification.
Option #1: Hire a full-time member of Quality to stand over the packaging line to be checking labels, lot numbers, fill levels, etc.
- Discussion: There may be companies reading this saying, Wait, I can’t afford to have a Quality employee on the packaging floor full time. That’s OK; you need to interpret the regulations in a way that makes sense for you!
Option #2: Quality staff starts on the production line, ensuring the bottle fill level is correct, the correct labels are applied, the right product is used, etc. The Batch Production Record (BPR) allows a Packaging Manager or Lead to be responsible for in-process checks.
- Review: The final lot clearance is always completed by Quality. You achieve the same result from each example, but the implementation is different. Putting some Quality responsibility back to the production workers pays dividends, as it helps all employees become an extension of Quality. This reduces the Us-Versus-Them mentality with Production and Quality and supports the virtuous operations ecosystem. All departments are working together for a common goal. This is an excellent example of why you should hire a supplement executive who understands not just Quality Systems but also Operations. Implementing a quality system from a compliant and operational perspective will help your company grow lean and efficient.
There is so much more to being a compliant hemp-CBD manufacturer. Here are the free webinars cGMP Basics for Hemp-CBD Companies, Preparing for FDA Inspections, and Distributor Requirements for Hemp-CBD Companies to support your compliant growth.
Disclaimer: These are for informational purposes only and are not intended to replace competent legal or regulatory advice.
Asa Waldstein is a 20-year dietary supplement executive now focusing on bridging the compliance, marketing, and regulatory gap between the supplement and hemp industries. Asa also is the principal of the consulting company Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. Waldstein is chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, and his Regulatory Education Series platform regularly hosts free events for the community. Learn more and contact at AsaWaldstein.com.