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

To meet a growing concern over the quality of OTC drugs, NSF facilitated the NSF/ANSI 455-4 GMP audit standard with industry representatives, public health officials, regulators and consumer interest groups to promote safer OTC drug products for consumers worldwide.

The standard is designed to strengthen safety, quality and trust throughout the supply chain and encompass requirements from 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) Quality Guidelines, 1, 7 and 10, as well as additional retailer requirements. Certification to the standard serves as a communication tool between manufacturers, regulators, retailers, and consumers.

Once certified, brands will receive an NSF certificate with the globally accepted ANSI logo, use the NSF/ANSI 455 GMP certification mark according to policy and appear on the NSF Product and Services Listings for OTC Drugs GMPs. Certified clients will also have access to a dedicated 455 GMP certification co-marketing portal that contains certification marks and assets to help promote their certification.

The benefits of NSF/ANSI 455-4 GMP certification include:

• Increases protection of your brand and minimizes risks
• Prepares your facility for regulatory inspections
• Helps your facility to build a strong quality and GMP program
• Reduces the number of GMP audits and the financial costs associated with audits
• Helps in fostering a culture of product safety and quality within your organization
• Demonstrates your commitment to product safety and quality to your customers

Facilities involved in the manufacturing, packaging, and/or warehouse & distribution of OTC drug products are in scope for NSF/ANSI 455-4 and may apply for certification.

NSF has developed these tools to walk you through the certification process.

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

Information Guide: Provides additional background information about the NSF/ANSI 455 certification program.

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

NSF webinar: An essential guide to NSF/ANSI 455 GMPs

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