GMP Regulatory Compliance Testing Services

NSF International provides registration, certification and audit of Good Manufacturing Practices for dietary supplements, personal care products and OTC drugs.
Woman using digital tablet at a warehouse - GMP Regulatory Compliance Testing Services

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 health. NSF is committed to simplifying the auditing needs of every client, including retailers’ auditing needs through its GRMA certification program.

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. Manufacturers who achieve GRMA certification to NSF/ANSI 455 will automatically qualify for meeting these new GMP audit requirements for the NSF/ANSI 173 GMP registration.

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

NSF is one of the first organizations approved by the GRMA for its certification program using the NSF/ANSI 455 standards and has supported the GRMA mission for years.

Ready to Begin the Process?

Contact us with questions or to receive a quote.

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