cGMP 21 CFR Part 111 for Food and Dietary Supplements

Issued in June 2007 by Food and Drug Administration (FDA) in the United States, cGMP 21 CFR Part 111 regulation mandates that individuals engaged in the manufacturing, packaging, labeling, or holding of a dietary supplement must establish and adhere to current good manufacturing practices. This is to guarantee the quality of the dietary supplement and to ensure that it is packaged and labeled in accordance with the specifications detailed in the master manufacturing record.

Eurofins’ audit services on cGMP 21 CFR Part 111 helps manufacturers, exporters / importers, packaging companies, and storage facilities to fulfill such compliance effectively.

Key Requirements of cGMP 21 CFR Part 111

Under this regulation, companies are required to:

• Establish and follow current Good Manufacturing Practices to ensure the safety and quality of the dietary supplement
• Ensure that the dietary supplement is packaged and labeled correctly.

Eurofins’ Audit Services for Compliance

Audit is our backbone. Facilities can count on us to run on-site audit to assess their compliance against 21 CFR Part 111. Conducted annually, the audit will usually take 1.5 days to complete and the audit report will be submitted to technical review for certification. Upon successful completion, customers will get the final audit reports and 21 CFR Part 111 Certificate in 15 working days.

Designed for all stakeholders in the dietary supplements supply chains, our audit can cover a wide range of dietary supplements, including:

• Product Forms: tablets, capsules, powders, energy bars, and liquids
• Product Categories: vitamins, minerals, amino acids, herbs, and botanicals

In addition, riding on our robust expertise in the dietary supplement industry, we can provide various value-adding services to best support customers in their compliant journeys:

• Pre-audit consultation
• Pre-audit training
• Label review

Why Choose Eurofins’s cGMP 21 CFR Part 111 Services?

With experts in the US, we have robust experience on food and dietary supplements regulatory requirements for FDA compliance, as well as high level of proficiency in on-site audit. Our well-trained auditors are located globally to support customers with geographic proximity.

Eurofins possesses strong food testing laboratories around the world so customers can leverage dietary supplements testing services easily while working with us on the audit and training parts.

Our certification activities are provided by independent companies and separate from consulting activities. Such services are also presented and sold to clients separately, not in bundle or packaged format. Impartiality is safeguarded by Eurofins Assurance’ relevant policies to avoid conflicts of interest.