Independent registration demonstrates compliance with new GMPs
Ann Arbor, MI – Now that the new Good Manufacturing Practices (GMPs) have been announced by the U.S. Food and Drug Administration (FDA), the demand for GMP registration is greater than ever. Five new companies were recently registered by NSF International, bringing the total number of NSF GMP registrations awarded to seventy-one.
Under NSF's GMP Registration Program, companies are audited twice a year to ensure ongoing compliance with current GMP regulations. This process provides their customers reassurance that an independent, third-party audit is not a one-time event and that continuous improvement is a top priority.
Requirements of NSF’s GMP program include personnel training, quality assurance procedures, equipment design and maintenance, plant and ground maintenance and sanitation, production and process controls and testing and stability records. These requirements are included in NSF American National Standard 173-Dietary Supplements and are consistent with FDA’s GMPs.
“With the announcement of the final GMPs, GMP registration is more important than ever,” said David Abney, general manager, NSF Dietary Supplements and Functional Foods Certification Programs. “The following companies have demonstrated their commitment to complying with the GMPs and that quality is of the utmost importance.”
Enzymedica, Inc.- Port Charlotte, FL
CytoSport, Inc.- Benicia, CA
Main Street Ingredients- La Crosse, WI
AMT Labs, Inc.- North Salt Lake, UT
GMP for Sport™ Registration
Soft Gel Technologies, Inc.- Los Angeles, CA
Manufacturers that receive NSF GMP for Sport™ registration, such as Soft Gel Technologies, have also met additional requirements for laboratory operations, sourcing and traceability. Meeting these requirements verifies that athletic banned substances are not present, stored or manufactured at their facility.
All NSF GMP registered companies may use the NSF GMP mark in advertising and collateral materials to demonstrate that they have met all requirements of the NSF GMP Registration Program. They are also listed on the NSF website at http://www.nsf.org/Certified/GMP/Listings.asp.
Additional GMP services offered by NSF include:
- GMP One Step Ahead: http://www.nsf.org/media/enews/gmpsales.html
- GMP 9000 (ISO 9001 Registration) program: http://www.nsf.org/business/gmp_9000/index.asp?program=GMP9000
- GMP for Sport™
- GMP training
- GMP Source Book: http://www.nsf.org/cphe/educational_tools/gmp_sourcebook.asp
- GMP readiness audits
About NSF International: NSF International, an independent, not-for-profit organization, helps protect you by certifying products and writing standards for food, water and consumer goods (www.nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional services include safety audits for the food and water industries, management systems registrations delivered through NSF International Strategic Registrations, organic certification provided by Quality Assurance International and education through the NSF Center for Public Health Education.