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What Is a cGMP Facility?

What Is a cGMP Facility?

It’s always important to know where the items we use in everyday life come from and how they’re made. Whether the products we buy are created mindfully and sustainably can make the difference for a user’s experience. 

Some manufacturers are more diligent about their production process than others, and it’s crucial to be informed about such details as a conscious consumer. Particularly when it comes to the supplements we take, knowing this background can offer huge peace of mind.

 

What does cGMP stand for?

Companies that are committed to ethical and accurate product development generally conduct their production work in cGMP facilities. ‘cGMP’ stands for ‘Current Good Manufacturing Practice’ regulations. 

The U.S Food and Drug Administration (FDA) created these regulations to ensure that products including food and beverages, dietary supplements, and pharmaceuticals are manufactured ethically and accurately. CGMPs entail the utilization of systems that establish and enforce appropriate design, monitoring, and control of manufacturing processes and facilities. 

 

What are the requirements?

Adherence to cGMP regulations for dietary supplements assures the identity, strength, quality, and purity by requiring manufacturers to adequately control and document manufacturing operations. Acceptable observance of said regulations encompasses:

  • Establishing strong management systems

  • Obtaining quality raw materials

  • Maintaining robust operating procedures

  • Detecting product quality deviations

  • Conducting reliable testing in laboratories

If practiced appropriately, this system helps assure consistency, and prevent contamination and errors throughout the production process. 

 

How does ChromaDex test?

ChromaDex, the manufacturers of Tru Niagen®, ensures the accuracy of their products by testing for over 240 potential contaminants, including heavy metals, residual solvents, microbes, and other impurities. Their products go through a battery of 36 tests before it reaches consumer shelves. 

The efficacy and strength of ChromaDex’s products are verified as accurate per label requirements. 

Raw ingredients are tested in addition to the manufactured product, and product formulation goes back to the drawing board if any mistake is detected. 

Though ChromaDex’s expert scientists can narrow the margin of manufacturing error down to an extremely low percentage, standards established by ChromaDex require development procedures to be recalibrated and improved anytime an abnormality arises, no matter how small. 

Even the process of ensuring each bottle has the correct number of capsules is carried out fastidiously, with multiple evaluations conducted by multiple parties on every lot. 

 

ChromaDex has additional safety certifications. 

ChromaDex takes their safety certification process a step further than other supplement companies by having a legitimate third party annually assess their manufacturing practices. 

Government inspections can occur as rarely as every five to seven years if a manufacturing facility is generally considered well-run. Other organizations often fill in the inspection gaps.

With quality being a strong business pillar, ChromaDex decided to partner with NSF International as its GMP auditor.

The NSF enforces standards across scientific industries to verify product. They dictate the ideal systems and procedures with sound science at the heart of their mission.

A track record of successful NSF audits serves as added credibility for companies who want to guarantee customers that their product is high quality and genuine.

 

ChromaDex serves quality as the standard.

When products are manufactured in a cGMP facility, consumers can feel confident that they meet premium standards. 

ChromaDex continues to seek additional certifications to further bolster the confidence of their consumers. Among these are certifications issued by the International Organization for Standardization (ISO), plus Kosher and Halal organizations.