If you look at the cGMP regulations for Dietary Supplements, you’ll notice that only 1 subpart includes the words “holding” or “distributing” in its title. With only 10 or so individual requirements, the aptly-named Subpart M, “Holding and Distributing,” is shorter than most. If you’re thinking this means there’s a much lighter regulatory burden placed on companies that simply hold or distribute Dietary Supplements than on companies that manufacture them, you’d be right. At the same time, it’s incorrect to assume that regulations for holding and distributing Dietary Supplements are restricted to this single subpart. At least 8 of the 16 subparts that comprise 21 CFR Part 111 are applicable to holders and distributors.
Subpart M requires that product be held in a manner that prevents its contamination and deterioration, and preserves its purity, strength, and composition. Subpart M may require it, but Subparts B, C, and D provide the detailed regulations your facilities, equipment, and personnel need to follow to comply with it. To start, your warehouse has to be clean and pest-free. Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering. Your facility also needs proper drainage, ventilation, adequate space, and work lighting. (Is there sufficient airflow around products that are stored on upper warehouse levels? Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?) You must also make sure that the product you hold is not exposed to more heat, cold, humidity, or light than the manufacturer recommends. (Is the heat tunnel you use for sealing shrink wrap too hot? Do you have backup refrigeration? Do you need moisture sensors? Have all the machines you use to maintain environmental conditions been cleaned, serviced, inspected, and calibrated. When and by whom?) Finally, your employees have to be trained in warehouse operations and hygienic practices, and they have to be qualified for the positions they hold. And naturally, this training needs to be documented.
Because you cannot ensure the quality of the product you distribute without verifying the quality of the product you receive, distributors must institute some of the Quality Control measures identified in Subparts E and F. Incoming shipments must be checked against invoices and other paperwork, and applicable certificates of analysis must be verified. Product must be inspected for damage, and the procedures for storage and handling of damaged product must be documented and followed.
Even after your product has been delivered, your regulatory obligations have not been fully discharged. Subpart N outlines requirements you must follow when product is returned to you. Subpart O outlines your investigative and documentation responsibilities for any product complaints you may receive. Finally, as a distributor, you would likely play a key role in any product recall. Subpart P enumerates the records you must keep to respond appropriately to a recall, as well as demonstrate Part 111 compliance in general.
Perhaps to those involved in pharmaceutical manufacturing or clinical research, the regulatory burden placed on holders and distributors of Dietary Supplements may seem light. In fairness, comparatively, it is light. But that doesn’t mean complying with all the necessary Part 111 provisions is easy or straight forward. It takes even the veterans time, effort, and expertise to achieve compliance, and it takes vigilance to maintain it.
by Laurie Meehan
We at Polaris hope you find this information helpful. Contact us at info@polarisconsultants.com with a question or post a comment.
by Laurie Meehan
This blog discusses trends and issues in the pharmaceutical and dietary supplement industries. Click the SIGN UP link to subscribe to occasional notifications of new blog posts.
