XYMOGEN RECEIVES GOLD STANDARD FOR SAFETY, QUALITY IN MANUFACTURING
ORLANDO, Fla. — March 7, 2013 — Orlando-based nutraceutical company XYMOGEN announced today that its manufacturing facility has earned the prestigious NSF International Good Manufacturing Practices (GMP) and GMP for Sport Athletic Banned Substances Program registrations.
The GMP registration verifies that XYMOGEN has the proper methods, equipment, facilities and controls in place to produce dietary supplements. Those manufacturing practices were developed in accordance with the U.S. Food and Drug Administration’s (FDA) regulations on dietary manufacturing, packaging and distribution.
The GMP for Sport registration ensures that the XYMOGEN facility does not process ingredients from banned substances.
“With the GMP registration, our customers can be assured that XYMOGEN has met NSF International’s stringent independent registration process guidelines, which include facilities and manufacturing process inspections,” said Brian Blackburn, XYMOGEN’s CEO and president. “Facilities registered GMP conform to the highest verification process, including ongoing monitoring via two annual facility inspections, to ensure continued compliance with program requirements.”
XYMOGEN produces probiotics, antioxidants and a host of health supplements that are sold directly to health care providers. The NSF GMP registration ensures that XYMOGEN’s facility processes, manufactures and labels in a consistent manner and meets quality standards.
NSF International’s GMP for Sport program was developed to meet the growing demand of athletes, coaches and those concerned about banned substances in sports. NSF inspects facilities for a range of substances identified by leading sports organizations, such as the World Anti-Doping Agency (WADA).
“The Sport registration provides the highest level of assurance to practitioners by verifying that XYMOGEN’s facility is in compliance with NSF’s rigorous index of 165-plus banned substances standards,” Blackburn said. “While the registration was designed for athletes, it represents our continued efforts to ensure patients with compromised function of their gastrointestinal, hepatic and endocrine systems are not subjected to banned substances.”
To achieve NSF registrations, facilities must undergo a three-day audit to verify effectiveness at meeting specified criteria for cleanliness, sanitation, safety and efficiency. All lab work, testing and manufacturing processes must fall within federally regulated industry standards.
Once a company has been registered, it must undergo subsequent audits every six months.
XYMOGEN opened its new 136,000-square-foot manufacturing facility and headquarters in Orlando last May. The company began preparing for the November NSF audit in August, following a four-day audit by the FDA in July, according to Andres Gomez, XYMOGEN’s quality control/quality assurance manager.
“We passed (the FDA audit) with flying colors,” Gomez said. “That established a precedent for what we had been doing for quite some time, which was ensuring we were complying and being a responsible player in the industry. It was proof that we were doing things well.”
XYMOGEN has always complied with industry standards and regulations, he said, but the registration “means now we can prove it.”
About NSF International
Based in Ann Arbor, Mich., USA, NSF International is a global independent public health organization that writes standards and tests and certifies products for the food, water, health sciences and consumer goods industries. Established in 1944, NSF is committed to protecting human health and safety worldwide and operates in more than 150 countries. NSF has been collaborating with the World Health Organization since 1997 in water quality and safety, food safety, and indoor environments.
The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D, and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product lifecycle. The division also supplies pharmaceutical secondary reference standards, traceable to USP and EP standards. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.
NSF International offers ISO 13485 registrations for medical devices and CE marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Global Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through NSF Training and Education.
XYMOGEN, a family-owned, health sciences company with headquarters in Orlando, Fla., has been providing high-quality dietary supplements to licensed health care practitioners for more than a quarter century.
The nutraceutical company has introduced numerous innovations to the functional medicine community; its Medical Board of Advisors consists of clinical practitioners who represent a broad range of specialties.
XYMOGEN’s strength as a company was reinforced in 2007, 2008, 2010, 2011 and 2012 when it was recognized by Inc. Magazine as one of the 5,000 fastest-growing private companies in America.
The company’s 136,000-square-foot manufacturing facility is GMP (good manufacturing practices) and GMP for Sport Athletic Banned Substances Program registered by NSF International.
More information is available at www.xymogen.com
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