Supplement GMP: Manufacturing With Only The Best Practices
GMP Manufacturing Question: Can You Help Me With Regulations?
As a nutritional supplement company you face several levels of regulation, most of it overseen by the Food and Drug Administration (FDA).
As your supplement manufacturer we can help you comply with these regulations at two levels:
- It is our job to comply with FDA Good Manufacturing Practices (GMPs) when manufacturing your products;
- We can help you ensure that your labels are FDA-compliant.
FDA And GMP Manufacturing
Despite the 1994 mandate for the FDA to establish GMPs and enforce them, the FDA did not start to implement and enforce GMPs until 2007. The last stage of this implementation, affecting small companies and their contract manufacturers, took place in 2010.
Most of the practices outlined in the FDA requirements are practices that many manufacturers already followed. They were simply good business standards. Manufacturers with a core commitment to quality applied these to their procedures long before they became regulations.
Now, even though everyone is required to follow GMPs, manufacturers who already followed industry standards have been able to make a smoother transition to ensure that production meets FDA requirements. Most of the steps are already in place. And the employees of the company already have expertise and a commitment to help maintain quality control.
However, too many contract manufacturers, as evidenced by the number of GMP-related warning letters sent out by the FDA in 2010, were not prepared to make this transition smoothly. Their inability to pass FDA inspections led to major production halts which in turn affected their clients’ businesses.
So when you discuss meeting GMP regulations with potential contractors,
- Ask them about their history in using GMPs. Did they use GMPs before the FDA enforcement?
- Ask them if they hold internal audits to preemptively improve on quality and safety measures during production.
- Ask them what percentage of their employees belong to their quality control teams.
Answering these questions will help you gain an understanding of their commitment to quality and good manufacturing practices independent of FDA requirements. When this core commitment is there, meeting these requirements is easier than ever.
FDA And Marketing
The second layer of FDA regulation affects the language you use to communicate with your customers. Essentially, in order to be classified as a food and not as drugs with the required licensing involved, nutritional supplement companies cannot talk about how their products affect disease.
You can talk about how your product helps support the normal, everyday healthy functioning of the body. But not how your product prevents, alleviates or cures a disease.
Most of the work you need to do to comply with these requirements falls outside of the responsibility of your contract manufacturer. Your marketing materials are where these regulations come into play.
However, there is one area that we can help you on this: Your labels.
As part of our label design services, we can help you develop FDA compliant labels. In fact Vitakem is one of the few manufacturers whose staff took an advanced course offered by the Natural Products Association on FDA-compliant dietary supplement product labeling. (Ask us to see our certificate of attendance.)
And to make it even easier for you to make sure your labels are compliant, we have a special service in place. If you already have a label designed but are unsure of whether it meets FDA requirements, we will assess it for FDA compliance – free.
Not many manufacturers can or do offer this service. But we knew this service was essential for our customers. We’ve seen too many clients, threatened with seizure of their products, forced to relabel thousands of bottles because they were not done right in the first place.
We don’t want to have this happen to you.
A Good Contract Manufacture Takes The Worry Out Of GMP Manufacturing
It can feel somewhat intimidating at first to enter into this industry rife with regulations. You can almost feel the prickle up your spine as you think about FDA inspections.
But in fact the regulations are a boon to this industry. We’ve had a hard time gaining the public trust due to the bad business dealings of a few bad apples. A few miscreants can jeopardize the reputation of the industry as a whole.
And despite the negative media sparked by some of these bad guys, most companies already follow GMPs.
For most manufacturers and supplement companies, in fact, meeting GMP regulations is simply a matter of continuing to follow the same good industry protocols we’ve always followed.
And because of this experience and familiarity with the required practices, we can make your work in this industry easier than ever. If you have more questions about GMP manufacturing compliance, FDA labeling or any regulatory concerns, please contact our account management team.
We’re looking forward to helping you be part of this industry without breaking a sweat over regulations.