Botanical extract supplier revamped facilities to gain compliance in record time.

March 18, 2013

3 Min Read
Euromed scores GMP, ISO certs

Euromed is pleased to announce it has earned the stature of being a Good Manufacturing Practices (GMP) facility as registered by NSF International … and in record time. This assures all of Euromed’s customers, natural health supplement manufacturers and cosmetic companies that each and every botanical extract they get from Euromed is safe, efficacious and produced to the highest quality standards. Showing its commitment to excellence even further, Euromed was also awarded “Green” 14001 Certification from ISO, the International Standardization Organization. This award demonstrates Euromed’s dedication to establishing and maintaining sustainable and environmentally friendly manufacturing processes.

The powerful combination of these major Global Certifications make Euromed the go-to facility when looking for the highest quality botanical extracts. The NSF and ISO marks offer proof positive to any health supplement company that Euromed is reliable, dependable and offers assurance, safety and confidence. This is more important than ever before, not only from consumers who demand quality and safety, but also from the increasing scrutiny from the FDA.

Reliability and regulatory compliance: more important than ever
The FDA has been busy! And it appears the agency plans to continue its vigilance throughout 2013. It has been in full force to enforce the regulation 21 CFR 111, going after dietary supplement companies by conducting more than 370 inspections. A whopping 70 percent of these random inspections did not get good report cards, resulting in FDA Form 483 observations, and the escalations to warning letters, and then to some with even more severe measures. The FDA expressed concern that too many manufacturers are not following “the basic tenets of cGMPs, and … as regards manufacturing in general, those tenets are not being adhered to, or in many instances are completely absent.”

“We help companies in the natural health industry to keep the integrity of their company and their cutting-edge formulations out of the FDA “searchlight,” and, if desired, placed in the “spotlight” to be held up as a shining example of excellence and regulatory compliance,” stated Joe Veilleux, CEO of Euromed USA and a registered pharmacist.

Setting the highest standards
GMP registration verifies that Euromed has the proper methods, equipment, facilities, and controls ALL in place for producing dietary supplement products. The NSF GMPs were developed in accordance with the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 111 Regulation on dietary supplement manufacturing, packaging, and distribution. Utilizing GMP guidelines assists companies in developing and maintaining proper controls in their manufacturing process so that products are processed, manufactured and labeled in a consistent manner, and meet quality standards.

Think green: ISO 14001 certification means a better product, better environment, better bottom line
Euromed took five years to implement these key changes by re-engineering its facility to meet the ISO criteria. These initiatives included major recycling of biomass, most notably the company’s flagship extract, milk thistle, whereby the post-extraction residue is used for animal feed due to its high nutrient content. The company actually gives this away! Other measures taken include having all wood pallets become compost, cleaner air and water, recycling printer toners and much more.

“We’re excited about this certification because it verifies that we’re one of the world’s leaders in environmentally friendly production,” Veilleux says. “That’s very important to us—we rely on plants, the Earth’s natural, renewable resources, not only for our business but for our personal health.”

 

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