cGMP 21 CFR Part 111 for food and dietary supplements
United States Food and Drug Administration (FDA) 21 CFR Part 111 regulations mandate that individuals engaged in the manufacturing, packaging, labeling, or holding of a dietary supplement must establish and adhere to current good manufacturing practices (cGMPs). By law, all such products sold in the United States must comply with this regulation. Manufacturers of these products are subject to US FDA regulatory inspection, and proof of 21 CFR 111 GMP compliance is often required along the supply chain by importers, retailers, and customers.
Eurofins’ audit services on cGMP 21 CFR Part 111 helps manufacturers, exporters/ importers, packaging companies and storage facilities to demonstrate compliance effectively.
Key requirements of cGMP 21 CFR Part 111
Under this regulation, companies are required to
- Manage personnel capacity, hygienic practices, roles and responsibilities, and competency.
- Manage and maintain, utensils, equipment and the physical plant and grounds.
- Establish production and process controls, including specifications, and clear MMRs and BPRs.
- Establish an effective and independent quality control system.
- Demonstrate control over warehouse and distribution operations.
- Set clear processes for product complaints and returned products, including any option for reprocessing.
- Maintain a compliant document control system.
Eurofins' audit services for compliance
Audit delivery is our backbone. Facilities can count on us to deliver a high quality, efficient on-site audit, conducted by a competent expert nearly anywhere in the world. Conducted annually, the audit duration is typically 1.5 – 3 days, depending on site size and complexity of operations. Any findings will be reviewed as part of the closing meeting and the audit report will undergo technical review for review and certification. Upon successful completion of programme requirements, customers will get the final audit reports and 21 CFR Part 111 Certificate within 15 working days.
Designed for all stakeholders in the dietary supplements supply chain, our audit can cover a wide range of dietary supplement manufacturing, packaging and warehouse/distribution operations.
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 auditing. Our experienced, well-trained auditors are located globally to support customers with geographic proximity.
Eurofins possesses a wide portfolio of dietary supplement services, with strong food testing laboratories around the world, as well as training and GMP auditing and certification. Customers can efficiently address all compliance maintenance and verification needs globally.
For dietary supplements, Eurofins Assurance also offers:
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.
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