GMP certification is the difference between a product that consumers, marketplaces, and regulators can trust and a product that gets ignored — or might even be ineligible for sale. This internationally accepted standard of product quality isn’t easy to receive, but manufacturers that do achieve GMP status can be counted on to offer safe, reliable products that consumers choose instead of others.
In this guide, learn what it means to be GMP certified and why you should choose a supplement or gummy manufacturer that has gone through the GMP certification process.
What Is GMP?
GMP stands for “Good Manufacturing Practices,” and it has been the gold standard of manufacturing safety since the 1960s. Originated by the US Food and Drug Administration (FDA), GMP certification is now recognized worldwide by organizations like the European Medicines Agency (EMA) and World Health Organization (WHO).
Rather than taking a one-size-fits-all approach, GMP offers a flexible rulebook that can apply to everything from food production to pharmaceutical manufacturing. At its core, GMP ensures quality and safety at every stage of the manufacturing process — from sourcing of materials and ingredients to in-house production procedures to packaging and labeling requirements.
For a supplement or vitamin manufacturer, GMP certification provides a guarantee of safety and reliability by covering stages of the production process such as:
- Raw materials quality standards
- Quality control systems
- Personnel conduct standards
- Proper documentation practices
- Acceptable forms of equipment
- Product testing thoroughness
- Product labeling and packaging
- Recalls and customer complaints
GMP Certified Meaning
If a manufacturer says their products are GMP-certified, this means an independent organization has thoroughly evaluated their processes and confirmed that they meet the Good Manufacturing Practices standard. These organizations, such as NSF, have received accreditation from the FDA to issue GMP certification, a process that commonly involves:
- On-site audits
- Documentation reviews
- Lab testing
GMP certification isn’t perpetual — manufacturers must regularly re-apply for certification to remain in compliance. While some manufacturers might claim to follow GMP standards even though they aren’t certified, only full certification provided by an accredited body is sufficient to assure consumers they’re choosing a safe and high-quality product.
What is GMP Certified for Supplements?
If a supplement manufacturer claims their products are GMP-certified, this means they’ve met the standards of an accredited GMP certifying organization — specifically for supplement manufacturing. It shows that every single aspect of their production process has been reviewed and judged satisfactory, from:
- The ingredients they use
- Where and how they put those ingredients together
- The practices their employees follow
- The documentation they keep
- The quality standards they adhere to
- The packaging and labeling they use
- The testing they use to ensure quality and safety
It’s not easy to achieve GMP certification as a supplement manufacturer, whether you’re making creatine gummies or melatonin drops. This certification shows that the manufacturer has gone above and beyond to ensure product quality and customer trust.
What Does It Mean to Be GMP Certified?
“GMP-certified” meanings can vary somewhat between industries, but receiving a GMP certificate always requires meeting very strict standards set by an accredited certifying agency. A co-packer or another type of manufacturer can’t simply say they’re GMP certified and expect anyone to believe it’s true — it’s necessary to actually receive a valid Good Manufacturing Practices certificate from an organization that has been accredited by the FDA.
Once a company is fully GMP certified, this means that they:
- Always use quality ingredients
- Run a safe and compliant organization
- Can be counted on to produce clean products
- Care about their reputation enough to become certified
What Are GMP Certified Supplements?
In the supplements industry, GMP certifications show that certified manufacturers have chosen to use safe ingredients and put them together in a rigorous and ethical way, resulting in reliable products that can be counted on to contain the advertised components and offer the expected effects. There’s a world of difference between GMP and non-GMP supplements — if supplements aren’t GMP-certified, there’s no telling what’s in them or how they were made.
Is GMP Certification Important?
Yes, Good Manufacturing Practices certification isn’t just important — it’s essential. While not strictly required by law, a GMP license shows that a manufacturer takes quality and safety seriously. It might even be their product’s ticket into certain marketplaces.
Both retailers and consumers want to know that they can trust products. GMP certification provides that trust — retailers know that they’re putting a reputable product on their physical or digital shelves, and consumers know that they’re only letting high-quality ingredients into their bodies.
What Are the Benefits of GMP Certification?
Once a manufacturer has achieved GMP certification, a world of opportunities opens up. Their products have gained access to the most prestigious domestic and international marketplace, and they now have GMP certificates to show brands, retailers, and consumers who might have questions about quality and safety.
For brands looking for a reliable source of white-label inventory, GMP certified products cover all the bases by:
- Ensuring ingredients are high-quality and consumer friendly
- Making sure they have access to all major retailers
- Establishing product safety in case of complaints
- Providing confidence when advertising features and benefits
Working with a GMP-certified manufacturer is the right call for any brand with long-term success as a goal. Simply put, a GMP lab is trustworthy while a manufacturer that hasn’t gone through GMP certification can’t be counted on for reliability and safety.
How to Get GMP Certified
To become certified GMP, a manufacturer has to go through a considerable list of steps and make sure their operation is fully compliant with international standards. Some examples of GMP certification requirements include:
- Implementing a comprehensive quality management system (QMS)
- Establishing reliable standard operating procedures (SOPs)
- Going through the HACCP (hazard analysis critical control point) process
- Setting up corrective and preventive action (CAPA) protocols
From a practical standpoint, manufacturers must:
- Train personnel on qualifications, hygiene, and protocol awareness
- Segregate facilities, establish cleanrooms, and practice proper pest control
- Calibrate, validate, and maintain equipment
- Keep batch records, deviation reports, and other forms of documentation
- Test purity, strength, and composition of products
How Long Does It Take to Become GMP Certified?
The amount of time it takes to receive a Good Manufacturing Practice certificate varies depending on the issuing organization, the size of the operation, and the soonest availability for audit scheduling. For smaller organizations, certification may be complete within as little as 2-4 weeks.
For complex facilities requiring upgrades or other compliance fixes, becoming fully certified can take 3-6 months. In rare circumstances, GMP facility certification can take more than a year, but that’s usually only if the certifying agency has limited availability for audits or if significant issues are uncovered during the auditing process. Annual renewal of a GMP certified lab generally only takes 1-2 days.
GMP vs NSF: What's the Difference?
GMP is a type of certification; NSF (National Sanitation Foundation) is an FDA-accredited organization that offers GMP certification services. If a manufacturer simply claims that they’re GMP-certified, they might not have anything to back it up. If they say they’re GMP-certified through NSF, however, this means an accredited certifier investigated their operations and found them to be compliant with international guidelines.
NSF actually predates the establishment of Good Manufacturing Practices by nearly two decades. It was one of the first organizations in the United States to establish standards for hygiene and sanitation in manufacturing, and NSF has since expanded their reach globally to become one of the world’s most-respected GMP certifiers.
Do You Need GMP Certification for Amazon?
GMP certification is necessary for selling dietary supplements through Amazon. According to the official page at Amazon Seller Central, dietary supplements must be “manufactured in a facility compliant with the FDA's Current Good Manufacturing Practice regulations” to be sold on Amazon, and they must also comply with the online commerce platform’s policies “via third-party testing on an annual basis.”
However, not all categories of products generally considered supplements are strictly defined as “dietary supplements” under Amazon’s official guidelines. If you are unsure whether the products you want to sell on Amazon fall under their definition of dietary supplements, contact Amazon Seller Central support.
Even if Amazon does not strictly require GMP certification for your particular category of products, it’s still a good idea to proactively attain GMP status. Amazon may never ask you to prove your products are GMP-compliant, but becoming certified anyway covers your bases, and customers are more likely to trust GMP products.
TRUSTWORKS: Work with a GMP Certified Supplement Manufacturer
Following GMP guidelines may not be easy, but it’s the core of our promise at TrustWorks. Quality assurance is critically important to us, and the best way to prove our products are reliably high-quality is to show we’re following GMP regulations to the letter.
Even major pharmaceutical manufacturers often struggle to make it through a GMP audit. For us, though, GMP compliance has been at the forefront of our minds since we first started establishing our manufacturing process, making it easy to meet or even exceed the most rigorous GMP requirements.
Our GMP-compliant facilities always pass audits. GMP inspections never turn up irregularities. We’ve made sure of this by tailoring our entire business model around quality, reliability, and — most importantly — trust. Rely on TrustWorks for products that exceed regulatory standards and amaze your customers. Rely on TrustWorks for trust.
