Dietary Supplements GMP Registration
- Benefits of Registration
- Why Work With NSF?
- GMP Registration Process
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 FDA’s 21 CFR part 111.
NSF International’s GMP Registration Program enables manufacturers to become independently registered by NSF to meet 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.
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 are 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.
- 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
- We email a confidential audit report and corrective action report (CAR) showing non-conformances to the customer.
- The customer submits CAR responses through the private NSF Online site, and NSF reviews the responses.
- Once NSF approves all CARs, we send the NSF GMP registration certificate to the customer.
- The company is then listed on the NSF GMP listings page and in the NSF GMP Source Guide.
- NSF’s marketing team can work directly with the company to promote its facility registration to the public.
- The entire audit and CAR response/submission/approval process is completed twice annually to continue the registration.
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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.
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.
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.
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.
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.
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.