Why does certification matter?
In a market that moves as quickly as the dietary supplement industry, consumers have legitimate concerns that products may not contain the ingredients listed on the label or may contain something that is not listed. Ensuring product safety and quality is of the utmost importance and that process begins with Good Manufacturing Practices (GMP).
The National Sanitation Foundation (NSF) is an independent organization that creates standards for many industries, including dietary supplements. One such standard is the NSF/ANSI 455-2 which provides for the Good Manufacturing Practices (GMP) of dietary supplements. This GMP standard aligns with 21 CFR Parts 111 and 117 meaning that expectations from the FDA are also included within the framework.
NSF/ANSI 455-2 is also the first step towards additional certifications, including product certifications such as NSF/ANSI 173 Contents Certified and NSF Certified for Sport®.
Who needs NSF/ANSI 455-2?
The certification applies to operations that manufacture, package finished products, store raw materials and/or finished goods in their warehouse and distribute supplements to retailers, e-commerce platforms or other facilities.
How does certification happen?
Important elements of the NSF/ANSI 455-2 standard include manufacturing controls and facility and equipment maintenance. The standard ensures that companies have robust systems in place to control vital aspects of manufacturing including formulation, blending and packaging. It also requires manufacturers to maintain their facilities and equipment to keep them clean and prevent cross-contamination.
The process to become certified involves the following:
- Quality management – looking at the facility’s standard operating procedures (SOPs), record keeping and other documentation
- Facility and equipment – an in-person inspection to verify that the facility is sanitary and well-maintained. Auditors review documentation, observe manufacturing processes and interview key members of staff
- Traceability – an audit verifying that there is a clear and stringent process for tracking of raw materials through to the finished product
Most importantly NSF/ANSI 455-2 is an ongoing commitment to quality standards. The certification is not a one-time event; to maintain certification companies undergo regular audits to ensure ongoing compliance.
What does the mark represent?
- Credibility – The certification is among the industry’s most recognized and indicates that a company has met the stringent requirements outlined in the NSF/ANSI 455-2 standards. The mark is an indication that the company is committed to engaging with gold standard practices when it comes to the manufacturing of dietary supplements.
- Trust – Knowing that the facility has undergone thorough auditing and has met the quality standards is crucial in an environment where there have been examples of contaminated products. Consumers recognize the NSF/ANSI 455-2 certification mark, giving them confidence in the product.
- Market access – NSF/ANSI 455-2 certification can be a requirement to enter specific markets or work with individual retailers. This is a standard recognized by Amazon for dietary supplement compliance.
Mineralife Nutraceuticals’ NSF/ANSI 455-2 certification is an indication to our current and future customers that we have facilities, equipment, standard operating procedures, and quality controls in place to ensure that high-quality dietary supplements are being manufactured here in Colorado Springs, CO. To work with us, get in touch here.