Manufacturers Can Get a Head Start on Meeting FDA’s GMPs
Ann Arbor, MI – To help manufacturers prepare for the upcoming GMPs, NSF International today announced a new Good Manufacturing Practices (GMP) program called "One Step Ahead." The new program is in response to an Office of Management and Budget announcement that has given final clearance for GMP regulations for dietary supplements.
The One Step Ahead Program includes a special web-based service center (www.nsfgmps.org) that was developed to help manufacturers get ready for the new Food and Drug Administration (FDA) GMP guidelines, which are projected to be available soon.
Building on its long-standing history in writing national standards, NSF led the development of the only American National Standard for Dietary Supplements – NSF/ANSI Standard 173. In addition, NSF is the only independent, certification organization accredited by the American National Standards Institute and the Standards Council of Canada to test and certify dietary supplements.
“This experience combined with NSF’s technical expertise in providing GMP facility audits and registration services will keep manufacturers at the forefront of regulatory requirements, ensuring they are GMP compliant,” said David Abney, the new general manager of NSF’s Dietary Supplements and Functional Foods Certification Program.
Compliance with the cGMPs helps assure the product produced has the identity, strength, composition, quality and purity that it is represented to possess. Being audited to these requirements by NSF will help manufacturers continually improve their processes and ensure that consistent, high-quality products are produced.
NSF auditors, who are located worldwide, will evaluate the production facility for compliance with cGMPs. Any non-conformances will be noted, and the facility will have the opportunity to complete corrective actions. This proactive solution will help ensure compliance with the FDA requirements and prevent citations from an FDA auditor in the future.
NSF will also conduct two audits per year to ensure continued conformance.
“Although the final regulations are in development, we believe that now is the time for NSF to offer the industry a one-stop resource on GMP services so that they can stay one step ahead as these new regulations are promulgated,” said Abney. “Ultimately, we believe this means establishing a long-term relationship with manufacturers to help them improve the quality of dietary supplements from production to inspection to the market.”
Under the GMP One Step Ahead Program, NSF also offers manufacturers a GMP Source Book (http://www.nsf.org/cphe/educational_tools/gmp_sourcebook.asp), which contains Standard Operating Procedure (SOP) templates and a trial self-audit tool to help facilities become GMP compliant. The GMP Source Book also includes a CD-ROM with downloadable SOPs that can be customized for each facility. In addition, through NSF’s subsidiary, Global Lifescience Solutions (http://www.nsf.org/business/global_lifescience_solutions), manufacturers can access consultants who can help design a GMP compliant system, and also perform readiness audits to ensure a facility is ready for the upcoming GMPs.
These auditing and consulting services are complemented by NSF’s in-house ISO 17025 accredited chemistry and microbiology laboratories (http://www.nsf.org/business/laboratory_services), which can provide quality control testing and ingredient verification.
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.