NSF/ANSI 455 Standard Transition for Supplements, Cosmetics and OTCs

Overview:

NSF International has worked with industry representatives, public health officials, regulators and consumer interest groups to develop the NSF/ANSI 455 GMP audit standards over the past five years. NSF International is transitioning clients from its current GMP registration (NSF/ANSI 173 Section 8) to NSF/ANSI 455 GMP certification to be able to certify facilities to a consensus-based national standard, and to allow manufacturers to reduce their annual audit burden.

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

The updates to the NSF/ANSI 173 GMP registration for dietary supplements audits implemented in 2019 were the first step toward this new standard, and incorporated many of the audit requirements of NSF/ANSI 455-2. For manufacturers, the key differences between GMP registration and the NSF/ANSI 455 GMP certification are:

  • The leading GMP audits for dietary supplements, cosmetics and OTC drugs based on current Good Manufacturing Practices and current federal regulations for each scope
  • A defined audit process that determines audit duration, timeline for 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) made up of leading retailers, manufacturers and other stakeholders

On-Demand Webinar: Introduction to the standards to make the move more straightforward while providing background information. This session is no cost to you.

 

NSF/ANSI 455-2 Dietary Supplements

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Transition smoothly from NSF/ANSI 173 GMP registration to NSF/ANSI 455-2.

To help you understand this new international standard for Good Manufacturing Practices (GMPs), NSF has developed resources to simplify your migration process.

If you are a current NSF client, please check the Announcements section of your NSF Connect portal for additional tools.

FAQ: Our team of experts have answered a list of frequently asked questions (FAQs) for your convenience.

NSF/ANSI 455 Process Overview: Offers a clear overview of the process in becoming NSF/ANSI 455-2 certified.

Transition Guide: Contains a full overview of NSF/ANSI 455-2 GMP certification, a comparison chart of the new standard vs. GMP registration, a transition timeline and a detailed comparison table of audit templates.

Information Guide: Contains facts about NSF/ANSI 455-2, key changes from NSF/ANSI173 GMP registration and information about how to prepare for the new standard.

GMP Summit Videos: Review the breakdown of the upgraded standard as the technical team goes through each of the sections of the standard. Make the move to NSF/ANSI 455-2 more straightforward while gaining background information about the standard. The sessions are no cost to you.

On-Demand Webinar: Make the move to NSF/ANSI 455-2 more straightforward and learn background information about the standard. This session is no cost to you.

NSF/ANSI 455-3 Cosmetic and Personal Care Products
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To help you understand this new international Good Manufacturing Practice (GMP) standard, NSF has developed resources to simplify your certification process.

If you are a current NSF client, please check the Announcements section of your NSF Connect portal for additional tools.

NSF/ANSI 455 Process Overview: Offers a clear overview of the process in becoming 455-3 certified.

Information Guide: Contains facts about 455-3, key items from the new standard and information on preparing for upcoming audits.

GMP Summit Videos: Review the breakdown of the upgraded standard as the technical team goes through each of the sections of the standard. Make the move to NSF/ANSI 455-3 more straightforward while gaining background information about the standard. The sessions are no cost to you.

On-Demand Webinar: Make the move to NSF/ANSI 455-3 more straightforward and learn background information about the standard. This session is no cost to you.

NSF/ANSI 455-4 Over-the-Counter Drugs (OTCs)

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To help you understand this new international Good Manufacturing Practice (GMP) standard, NSF has developed resources to simplify your certification process.

If you are a current NSF client, please check the Announcements section of your NSF Connect portal for additional tools.

NSF/ANSI 455 Process Overview: Offers a clear overview of the process in becoming 455-4 certified.

Information Guide: CContains facts about 455-4, key items from the new standard and information on preparing for upcoming audits.

GMP Summit Videos: Review the breakdown of the upgraded standard as the technical team goes through each of the sections of the standard. Make the move to NSF/ANSI 455 more straightforward while gaining background information about the standard. The sessions are no cost to you.

On-Demand Webinar: Make the move to NSF/ANSI 455-4 more straightforward and learn background information about the standard. This session is no cost to you.