What does GMP/cGMP stand for and who’s responsible for enforcing these regulations?
GMP or cGMP (which stand for ‘Good Manufacturing Practices’ and ‘Current Good Manufacturing Practices’, respectively) are a set of best practices for dietary supplement manufacturing in the United States.
Establish, maintained, and update by the U.S. Food and Drug Administration (FDA), these regulations establish the baseline requirements for dietary supplement companies and manufacturers looking to produce dietary supplement products. Covering everything from labeling and packaging to ingredient sourcing and formulation – GMPs have been put in place for each step of the dietary supplement manufacturing process.
Along with acting as a quality control and assurance measure, GMPs requirements help ensure that dietary supplement products consistently meet specifications for purity, strength, and composition.
GMPs are overseen and enforced by a number of well-established and credentialed third party auditors, like NSF.
How does a contract manufacturer become GMP-certified?
While the FDA requires that manufacturers adhere to the GMP regulations, it does not require manufacturers to be GMP-certified. That said, many of today’s dietary supplement manufacturers have earned and maintain GMP-certified status.
Manufacturers who wish to gain certification must willingly disclose their manufacturing facility, records, and practices to a comprehensive audit by a third-party organization. Assuming the manufacturer passes the audit, they may then be recognized as GMP-certified.
When it comes to third-party organizations capable of granting a certification, NSF is arguably the most well-known. During an audit, a team auditors will arrive at the manufacturing facility, and over a period of several days they’ll inspect and audit all of the procedures, documents, and employee qualifications relating to dietary supplement manufacturing. Including factors like:
- The design and construction of physical plants
- Maintenance and cleaning of the plant and equipment
- Proper manufacturing procedures
- Quality control procedures
- Testing of materials and products
- Proper handling of consumer complaints
- Maintaining appropriate written procedures and records
Once they have their NSF (or other third-party) GMP certification, a manufacturer has to undergo regular follow-up audits several times a year if they’d like to maintain that certification.
Can I put GMP logos on my product label and packaging?
Most third-party auditors have a set list of rules and guidelines concerning how GMP labels can and cannot be used. If, for example, your supplement product is manufactured in a NSF GMP-certified facility, the NSF GMP-certified logo may not be used on your product packaging. The reason being that the GMP-certification was for the facility in which your products were manufactured, rather than the products themselves.
That said, NSF and other auditors will often offer additional testing and certification services for those looking for a more thorough level of testing and the ability to use an official NSF logo/label on their final supplement product. Additionally, many of these organizations will allow dietary supplement products that were manufactured in a GMP-facility to feature a generic logo (like the one featured to the right) to let customers know that the vitamins or supplements they’ve purchased have been manufactured according to GMP standards.
For those working with NSF, there are several online resources that outline when and how official NSF logos, marks, and seal may be used. One of those resources is, Using the NSF Mark – Do’s and Dont’s: How to Leverage Your NSF GMP registration and Product/Ingredient Certification.
As is the case with almost all label design questions, companies or brand owners seeking answers are advised to reach out to the organization in question and/or seek counsel from a professional who specializes in dietary supplement labeling, laws, and regulations.
How do I know if a contract manufacturer is GMP-certified? Is there a list manufacturers/companies that have been cited for GMP violations?
When it comes to knowing whether or not a specific contract manufacturer is GMP certified, one of the simplest things to do is ask. Along with providing the appropriate supporting documentation, any reputable manufacturer should be more than willing to provide you with answers questions you might have.
Similarly, when it comes to GMP citations or violations, simply asking a potential manufacturing partner about their history can be a simple and effective means to an answer. In instances where it’s disclosed that a manufacturer doesn’t have a pristine record, it’s (arguably) just as important to learn how that manufacturer or company responded to the citations. Did they ignore the issue(s) or did they take the necessary measures to fix the problem in a timely manner?
When it comes to finding out whether or not a company has received any warning letters or other serious citations, the FDA provides digital (and public) access to their record archives.
What else do I need to know about GMP Certifications before launching my product line?
The most important step is choosing to work with a manufacturing partner who will be capable of manufacturing your dietary supplement product (or products) in a facility that is GMP-certified that has been audited by a third-party organization like NSF. That’s 95% of what you need to know about GMP certifications.
The other 5% includes steps like:
- Maintaining records of all documentation you receive from your manufacturer.
- Deciding if and how you may want to use some type of logo on your label that references GMPs (see response to Question #3).
- Asking your manufacturer any questions you have about GMP (and recognizing that if they’re not willing to answer, you may want to consider another manufacturer).