GMP Certification

Demonstrate your commitment to product safety through NSF GMP registration for dietary ingredients or nutritional supplements (China) and NSF/ANSI 455 certification for dietary supplements, cosmetics and over-the-counter (OTC) drugs.

GMP certification and registration provides consumers and retailers with assurance that your product is manufactured utilizing industry best practices.

Benefits of GMP certification or registration 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 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

With input from industry representatives, public health officials, regulators and consumer-interest groups, NSF facilitated the development of the NSF/ANSI 455 GMP audit standards for dietary supplement, cosmetics, and OTC drug manufacturers and packagers, as well as for warehousing and distribution companies. These standards encompass regulatory requirements, retailer quality requirements and industry best practices and are designed to strengthen safety, quality and trust throughout the supply chain.

The portfolio of GMP standards includes:

• NSF/ANSI 455-2 Good Manufacturing Practices for Dietary Supplements
• NSF/ANSI 455-3 Good Manufacturing Practices for Cosmetics
• NSF/ANSI 455-4 Good Manufacturing Practices for OTC Drugs

GMP certification or registration provides consumers and retailers with assurance that your product is manufactured utilizing industry best practices.

The benefits of GMP certification or registration 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

NSF is accredited by the ANSI National Accreditation Board (ANAB) to provide certification to NSF/ANSI 455 standards. In addition, NSF and GRMA have signed an agreement for NSF to provide NSF/ANSI 455 audits to member suppliers through its GRMA certification program.

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

Companies with GMP certification or registration receive instant eligibility to enter their products into NSF’s product certification program (NSF/ANSI 173, NSF 229 and NSF Certified for Sport^®). These benefits extend to contract manufacturers. When your contract manufacturer is GMP compliant, you reduce the time and cost of NSF testing and product certification.

China Dietary Supplement GMP Certification

NSF’s China Dietary Supplement GMP Certification is developed based on China’s National Food Safety Standard, local GMP best practices, retailer requirements, and U.S. FDA federal regulations 21 CFR 111 and 21 CFR 117. It aims to provide Chinese consumers with higher-quality and safer dietary supplement options. This certification program is filed with the Certification and Accreditation Administration of China (CNCA) and issues official certificates.

GMPC

• GMPC（US）: The United States was the first country to advocate GMP. For cosmetics exported to the U.S., manufacturers must operate under the GMPC system issued by the U.S. FDA to ensure quality control during production and meet FDA regulatory requirements.
• GMPC（EU）: Issued by the European Council in 1995, the EU GMPC is part of the EU Cosmetics Directive 76/768/EC. This guideline significantly enhances product quality control during cosmetic production and is highly favored by EU buyers.
• GMPC (ASEAN): Cosmetics exported to ASEAN countries must comply with the ASEAN Cosmetics Directive, which includes GMPC guidelines issued by the ASEAN Committee. Without ASEAN GMPC certification, companies cannot prove their products are manufactured under GMP conditions when registering or filing with regulatory authorities in ASEAN countries.

 ISO 22716:2007

 ISO 22716:2007 is the international guideline for Good Manufacturing Practices (GMP) for cosmetics, issued by the International Organization for Standardization (ISO). It is incorporated into the EU Cosmetics Regulation EC1223/2009 and is one of the essential requirements for exporting cosmetics to the EU.

NSF offers GMP registration services for manufacturers and packagers of dietary ingredients and nutritional supplements sold in the Chinese market, as well as for distribution and warehousing companies. The audit is a robust evaluation of a facility’s prerequisite programs, good manufacturing practices (GMPs) and quality management systems (QMS) based on the requirements of regulations and industry best practices.

Companies with GMP certification or registration receive instant eligibility for entering their products into NSF's product certification program (NSF/ANSI 173, NSF 229, NSF 527, and NSF Certified for Sport). These benefits extend to contract manufacturers. When your contract manufacturer is GMP compliant, you decrease the time and cost of NSF testing and product certification.