Eggshell firm wins GMP certification

​

Dr. Kevin Ruff, the company’s director of scientific and regulatory affairs, told NutraIngredientsUSA.com: “Certification by NSF International demonstrates our continued assurance to maintaining exceptional quality standards, which has been made even more critical by the evolving regulatory environment in the US, the EU, and around the world​.

Doseage manufacturers​

“It allows finished doseage manufacturers who supply product to end consumers to have the confidence in the ingredients we supply​.”

Certification also proves ESM achieves independently audited standards which would be useful if regulatory authorities decide to inspect its facilities, added Ruff.

GMPs are regulatory requirements recognized worldwide for quality control and management of all aspects of manufacturing, from raw material control to finished product release. They also include employee training, validation of testing equipment, product traceability and facility maintenance.

Complying with the guidelines for processes, procedures, and documentation verifies that ESM Technologies-manufactured products have the identity, strength, composition, quality, and purity that they are claimed to possess.

It took the company about a year from application to receipt of the certification, said Ruff.

Ed Wyszumiala, general manager of NSF’s Dietary Supplement Certification Programs said: “By obtaining NSF GMP certification, ESM is demonstrating their commitment to producing quality, consistent ingredients for the dietary supplement industry. ​

“The value of ESM’s GMP certification is also transferred to their clients as they now have third-party verification that they are a qualified vendor that is meeting the highest GMP requirements.​”

Independent​

NSF International, an independent, not-for-profit organization, certifies products and produces standards for food, water and consumer goods.

According to the organization: “NSF’s GMP Certification Program enables manufacturers of dietary supplements, raw materials and ingredients to become independently certified by NSF International, demonstrating compliance with GMP requirements​.”

GMPs for the current NSF Dietary Supplements Program are included in NSF American National Standard 173-Dietary Supplements. This is the only American national standard for dietary supplements and is consistent with Food and Drug Administration (FDA) requirements, said NSF.