GMP Regulatory Compliance

Good Manufacturing Practices (GMPs) and NSF/ANSI 455 provide a system of processes, procedures and documentation for the dietary supplement, personal care and OTC industries.
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GMP Registration

NSF International independently registers manufacturers that meet GMP requirements. Registration services are available for manufacturers of dietary supplements, ingredients and raw materials, as well as distribution, warehousing and packaging companies that want to demonstrate a commitment to public safety.

Increase your company’s credibility and integrity and boost confidence in the preparedness of your facility for FDA inspection. Companies registered for GMP receive instant eligibility for entering products into NSF's product certification program. These benefits extend to contract manufacturers registered for GMP through NSF, too. When your contract manufacturer is GMP compliant, you decrease the time and cost of NSF testing and product certification.

Our global network of auditors and technical staff is committed to helping your facility achieve GMP registration. Receive in-depth audit reports, thorough corrective action guidance and rapid responses to your questions.

Transition from GMP Registration to NSF/ANSI 455 GMP Certification

By 2022, NSF will phase out our GMP registration service in favor of NSF/ANSI 455 certification.

Not quite ready to transition? We can still support you with an NSF GMP registration audit.

Receive a third-party audit certificate confirming your compliance to regulatory requirements and industry best practices in dietary supplement and functional food manufacturing. Advertise with the NSF GMP logo, so consumers and other industry leaders know instantly that your processes have been independently evaluated by a leader in testing, inspection and certification.

If you then decide to transition to NSF/ANSI 455, your team's hard work to attain GMP registration will support the similar requirements for the new standard.

NSF/ANSI 455 GMP Certification

With input from industry representatives, public health officials, regulators and consumer interest groups, NSF International facilitated the development of the NSF/ANSI 455 GMP audit standards over the past five years. We are currently transitioning clients from our current GMP registration (NSF/ANSI 173 Section 8) to NSF/ANSI 455 GMP certification. This transition allows NSF to certify facilities to a consensus-based national standard and helps manufacturers reduce their annual audit burden.

We are currently accepting applications for audits for dietary supplements (NSF/ANSI 455-2), cosmetics and personal care products (455-3) and over-the-counter (OTC) drugs (455-4). The current dietary supplement GMP registration will be phased out entirely by 2022, and the GMP registration for cosmetics will be phased out by 2021.

Updates to the NSF/ANSI 173 GMP registration for dietary supplements audits in 2019 were the first step toward this new standard and incorporated many of the audit requirements of NSF/ANSI 455-2.

Both registration and certification provide leading GMP audits for dietary supplements, cosmetics and OTC drugs based on current Good Manufacturing Practices and federal regulations for each scope. For manufacturers, the key features NSF/ANSI 455 GMP certification provides in addition to GMP registration are:

  • A defined audit process that determines audit duration, timeline for corrective action request (CAR) reviews and ongoing monitoring requirements
  • A grading system based on the number and severity of non-conformances
  • Best industry practices based on retailer requirements
  • Certification audits accredited by ANSI starting in 2020
  • Certification recognized by the Global Retailer and Manufacturer Alliance (GRMA), which is made up of leading retailers, manufacturers and other stakeholders

Ready to Begin the Process?

Contact us with questions or to receive a quote.

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