Good Manufacturing Practices (GMPs) are guidelines that provide a system of processes, procedures and documentation to assure a product has the identity, strength, composition, quality and purity that appear on its label. These GMP requirements are listed in Section 8 of NSF/ANSI 173 which is the only accredited American National Standard in the dietary supplement industry developed in accordance with the U.S. FDA’s 21 CFR part 111.
NSF International independently registers manufacturers as meeting GMP requirements. The program is open not just to manufacturers of dietary supplements but also to manufacturers of ingredients and raw materials, as well as distribution, warehousing and packaging companies, who want to demonstrate their commitment to public safety.
For more information about NSF's dietary supplements GMP registration, email firstname.lastname@example.org or call +86 21 52377700.
Benefits of Registration
Receiving independent GMP registration for your company:
- Increases your company’s credibility and integrity
- Offers a competitive advantage in the marketplace
- Increases confidence in the preparedness of your facility for FDA inspection
- Decreases the time and cost of NSF testing and product certification if your company is using an NSF GMP-registered contract manufacturer
- Creates instant eligibility to enter products into NSF’s product certification program
Why Work With NSF?
Beyond our commitment to thorough GMP registration and the extensive knowledge of our experienced auditors, our expert dietary supplements team offers an extensive range of additional services including co-marketing to support newly registered facilities. Services include:
- Communications expertise to assist in the development of press releases and educational materials
- Guidance on the use of the NSF GMP mark on your advertising and other promotional and marketing collateral
- Trade show tools that help you communicate your GMP registration to a wider audience
- A featured presence for your company in our biannual GMP Source Guide that showcases all GMP registered facilities worldwide
Our highly trained global network of auditors and technical staff is committed to helping your facility reach its GMP ambitions. Your NSF representative provides you with in-depth audit reports, thorough follow-up with any corrective action responses that may be needed and rapid responses to your questions.
GMP Registration Process
The GMP registration process consists of these stages.
1. Our expert auditors visit the facilities and assess:
- Physical plant and grounds
- Equipment and utensils
- Production and process control systems
- Holding and distribution
- Return of product
- Product complaints
- Records and recordkeeping
- Recall procedures
2. We email a confidential audit report and corrective action report (CAR) showing non-conformances to the customer.
3. The customer submits CAR responses through the private NSF Online site, and NSF reviews the responses.
4. Once NSF approves all CARs, we send the NSF GMP registration certificate to the customer.
5. The company is then listed on the NSF GMP listings page and in the NSF GMP Source Guide.
6. NSF’s marketing team can work directly with the company to promote its facility registration to the public.
7. The entire audit and CAR response/submission/approval process is completed twice annually to continue the registration.