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11 Important GMP Questions to Ask When Starting a Supplement Line

Last updated: January-24,2023

Critical GMP Questions to Ask Before Manufacturing Dietary Supplements

Whether it's in the news or everyday conversation, it's not uncommon to hear someone say, "The dietary supplement industry? No way is that regulated enough," yet these comments and claims couldn’t be further from the truth!

As anyone who's worked in the industry can tell you, the nutraceutical industry is regulated by hundreds (if not thousands) of federal and local laws, regulations, and best practices. Within that ever-growing and changing body of regulations, GMPs (sometimes written or referred to as cGMPs) serve as a key regulatory backbone for the industry. Regulations are GMPs. Understanding what GMPs exactly are can prove confusing for industry newcomers and brand owners who may be starting a supplement company for the first time.

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Becoming familiar with the current dietary supplement GMPs is a must! In an effort to help, we’ve answered the five most common questions we've seen new or first-time supplement brand owners ask about GMPs.

What is GMP/cGMP? Who is 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.

Established, maintained, and updated by the U.S. Food and Drug Administration (FDA), these regulations lay out 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.

Why is GMP Important?

GMP guidelines set by the Food and Drug Administration lay out the rules and regulations for manufacturing and selling food, drugs, health supplements and cosmetics. These regulations ensure the validity, quality, purity and safety of the products. These regulations help prevent and reduce the instances of product recalls, harmful effects, contamination, product failures, other errors and lawsuits that may arise from defective products.

GMP ensures proper production techniques, quality control and management, good quality raw material usage, effective operating procedures, comprehensive product testing and maintenance of consistent and safe environments. 

What is GMP Certified?

Good Manufacturing Practices (GMP) is a system designed to ensure that products are consistently manufactured according quality standards mandated by the Food and Drug Administration (FDA).

What Does GMP Mean in Supplements?

In the world of nutraceuticals, supplement manufacturers are audited 1-2 times per year by a third-party organization (usually the NSF) to ensure they are following the mandated rules and regulations. Most audits take 1-2 business days to complete, but may vary depending on the number of items the auditor uncovers during his/her inspection. After the inspector completes their audit, they will provide the manufacturer with a list of corrective actions that must be addressed and submitted within a specific period of time. It is not uncommon for a manufacturer to receive several corrective actions during a GMP audit.

What is a GMP Registered Facility?

A GMP registered facility is a production facility for the manufacture of pharmaceutical products such as drugs and supplements, in compliance with the GMP standards given by the FDA. It includes the manufacturing facility, the storage warehouse for raw materials and finished products, and labs for research and product testing.

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 of 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?

The short answer to this question is no.

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 of 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 answer all the 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).

Is GMP Necessary If There Is a Quality Control Laboratory?

Yes, GMP is necessary even if there is a quality control laboratory since it prevents errors that cannot be eliminated through quality control of the finished supplement product. GMP helps in producing good quality supplements instead of having to test the quality later on. Without GMP it is impossible to be sure that every unit of a supplement is of the same quality as the units of supplements tested in the laboratory.

Can Manufacturers Afford to Implement GMPs?

Yes. GMP is very helpful in the long run because it prevents manufacturing errors and defects that would later have to be rectified. Implementation of GMP is an investment in good quality supplements. Producing and selling poor quality supplements leads to loss of credibility.

Key Takeaways

There’s a reason why people say “you never have a second chance to make a first impression.” The same goes for a customer’s first impressions about your product quality. Making sure that you have your products made in a cGMP contract manufacturing facility is a simple way to make sure that your products stand out among the rest.

To know more about our services, call us at 855-492-7388 or send us your request to receive a free nutraceutical manufacturing quote.

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About the Author:

Vincent Tricarico

Vincent Tricarico is currently the Vice President of Contract Manufacturing at NutraScience Labs. With nearly 20 years of direct-to-consumer and business-to-business experience, Mr. Tricarico is a respected executive in the dietary supplement industry and is well-known for his ability to consistently build and grow successful teams that produce results. Over the years, his work has been published in many industry trade publications, such as Natural Products Insider, Nutritional Outlook, and WholeFoods Magazine.