3 cGMP Tips for New Supplement Brand Owners Looking to Start Production
cGMPs (Current Good Manufacturing Practice) or GMPs (Good Manufacturing Practices) are the FDA-established good manufacturing practices that have come to shape the dietary supplement industry. Even though the FDA isn’t responsible for enforcing these best practices (audits are the responsibility of third-party organizations such as NSF), for companies and brand owners looking to bring products to market, working within current GMP guidelines is paramount.
Even though many seasoned brand owners have the ability to navigate the sea of GMPs with ease, it’s not uncommon for industry newcomers to feel a bit lost. Even though there are dozens of useful cGMP-related tidbits out there, these are our top three cGMP regulations for dietary supplements, for first-time brand owners looking to keep their operations cGMP-compliant from start to finish.
3 cGMP Guidelines for New Brand Owners Looking to Start Production
1 – Working with a cGMP certified or compliant manufacturing space is a must.
Whether you’re looking to make use of your own facilities or work with a contract manufacturer who has their own, the facilities you use should be (at the very least) cGMP compliant. Though it’s certainly not the most exciting document on the web, those who wish to read the cGMP rules for dietary supplements, as the FDA has written them, can do so here.
Finding a cGMP compliant facility to manufacture your product(s) in should be one of your top priorities. When interviewing potential manufacturers, you should feel comfortable asking them any questions you might have about their facilities and cGMPs. If they’re hesitant or entirely unwilling to answer, our advice is to cross them off your list.
2 – Learn the rules for using GMP logos.
When it comes to cGMP regulations for dietary supplements, many of the seals and certificates associated with the nutraceutical industry, like the official GMP logo can only be used for certain applications. Fact of the matter is, NSF GMP Certification (one of the most popular GMP certifications) can only apply to manufacturing facilities, not products.
For those looking to incorporate a GMP logo into their packaging, there are two popular options: 1) Create a generic or in-house GMP logo that will let customers know that the product they’re purchasing has been manufactured according to current good manufacturing standards, or 2) Seek an additional NSF certification that test and verifies a supplements contents, which then allows for an NSF seal to be included on the packaging.
3 – Keep good records.
Though obvious, it’s still one of the most common industry oversights. From batch sheets to receipts, brand owners should keep and index any and all documentation that they receive from their manufacturing facilities. Not only is this a good practice to get into for the sake of general bookkeeping and other business logistics, but in the event of an audit, having all your production documents on hand will make the process that much easier.
Bringing Your Products to Market and Staying GMP Compliant
Along with these tips and the others that we've given over the years about cGMP regulations for dietary supplements, one of the most important things to keep in mind when it comes to keeping your operations cGMP compliant (from top to bottom) is that the value of being thorough cannot be understated. Allowing every element of the production/business cycle the time it needs to be complete efficiently, effectively, and correctly(the first time) is key.