GMP Regulatory Compliance
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.
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 GMP registration program to the NSF/ANSI 455 GMP certification program. 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.
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
NSF/ANSI 455-2: Dietary Supplements
NSF/ANSI 455-3: Cosmetics
NSF/ANSI 455-4: OTCs (Over-the-Counter Drugs)
Ready to Begin the Process?
Contact us with questions or to receive a quote.
News and Events
GMP Harmonization: NSF Is Approved for Amazon Supplement Sales Rules
May 7, 2021
NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training
May 19, 2020
To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.
NSF International’s Health Sciences Team Joins Fight to Save Lives With More Ventilators
April 23, 2020
NSF International’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.
NSF International to Perform Audits to New GRMA Standards
April 20, 2020