Q&A: Dietary Supplements GMP Registration

  • Open What are GMPs?

    Good manufacturing practices (GMPs) are guidelines that provide a system of processes, procedures and documentation to ensure the manufactured product has the identity, strength, composition, quality and purity that appear on its label.

  • Open What is NSF GMP registration and how is it obtained?

    NSF GMP registration is awarded to facilities that are in compliance with the standard NSF/ANSI 173 - Section 8. To achieve initial registration, facilities are audited to NSF/ANSI 173 - Section 8, which was developed in accordance with the FDA regulation 21 CFR 111 on dietary supplement good manufacturing practices (GMPs). The audit includes all aspects of the manufacturing process, from raw material control to finished product release, as well as employee training, validation of testing equipment, traceability and facility maintenance. Generally, the initial audit takes about three days.

    Following the audit, the company is given a detailed audit report and a corrective action report that explains any non-conformances found during the audit. Once all audit non-conformances are rectified and corrective action responses (CARs) are submitted to and approved by NSF’s expert CAR reviewers, the facility is GMP registered and appears in NSF’s official GMP registration listings.

    After initial registration, biannual audits of the facility are required to maintain registration.  Continued auditing, as well as the focus on submitting CAR responses to audit non-conformances, ensures that NSF GMP-registered companies meet the highest standards of both quality and compliance.

  • Open What types of facilities can become NSF GMP registered?

    NSF GMP registration promotes compliance along the entire dietary supplement supply chain. Facilities that can be registered in the NSF GMP program include dietary supplement manufacturers, packagers, suppliers, distributors and warehouses. NSF GMP registration is a global program, with registered facilities and experienced auditors located worldwide.

  • Open How does NSF/ANSI 173 relate to FDA 21 CFR 111?

    As of June 2010, every company involved in the manufacturing, packaging, distributing or warehousing of dietary supplements in the United States had to be compliant with the FDA regulation 21 CFR 111 on dietary supplement good manufacturing practices. While not identical, NSF/ANSI Standard 173 - Section 8 was written in accordance with this FDA regulation and is the standard for NSF GMP registration audits.

    Both NSF/ANSI 173 and the FDA’s 21 CFR 111 stem from DSHEA (Dietary Supplement Health and Education Act), which was passed in 1994 and states that the manufacturer is responsible for ensuring that its products meet specifications for composition, purity, strength and identity.

  • Open After becoming NSF GMP registered, how often will my facility be audited?

    The facility is audited twice per year.  The facility receives a full annual audit lasting two or three days, plus a one-day monitoring audit six months later.  To maintain compliance, this cycle continues as long as the facility remains in the program.

  • Open What are the benefits of NSF GMP registration?

    You receive many benefits from obtaining NSF GMP registration including increased credibility and a competitive advantage in the marketplace. Once your facility is NSF GMP registered, you receive an NSF GMP certificate and your company is listed on the NSF website and in the NSF GMP biannual sourcing guide. This helpful resource allows all types of facilities in the dietary supplements industry to connect with other NSF GMP-registered facilities to increase supply chain quality and compliance.