CUNSA, Solution 360 - Quality, testing and fulfillment
Quality, testing and GMP compliance
The quality of a dietary supplement is not something you can see—it must be demonstrated. Every product that leaves CUNSA is backed by a quality system that documents what it contains, how it was manufactured, and verifies that it meets its specifications batch after batch. We operate in compliance with FDA Current Good Manufacturing Practices (21 CFR Part 111), the standard that international buyers and health authorities expect to see supported by documented evidence.
What does it mean to manufacture under 21 CFR Part 111?
21 CFR Part 111 is the FDA regulation that establishes Current Good Manufacturing Practices (cGMPs) for dietary supplements. It requires batch-by-batch quality control, verification of raw material identity, documented process parameters, finished product testing and control, and complete traceability throughout the manufacturing process. It is not a certification or seal—it is a quality system that must be supported by records and documentation at every step. Manufacturing under this standard provides the foundation for the documentation required for product registration, regulatory compliance, and international export.
Tests: identity, power and safety
We verify what matters so the product is safe and delivers what it claims. Testing—performed with the support of qualified third-party analytical laboratories when appropriate—typically includes:
- Identity: Confirming that each ingredient is exactly what it is claimed to be.
- Potency / Assay: Verifying that the active ingredient is present at the declared level.
- Purity and Safety: Microbiological and contaminant testing according to established specifications.
- Finished Product Testing; Evaluation of physical characteristics and compliance with product specifications.
Each batch is accompanied by its Certificate of Analysis (CoA).
Stability studies
A supplement must maintain its quality throughout its shelf life. We conduct stability studies under internationally recognized guidelines (ICH type)—including accelerated conditions—to support the stated shelf life and storage conditions. This is the evidence that backs up the expiration date on your label.
Traceability and auditable documentation
If you need to reconstruct the history of a batch—for a customer, a retail chain, or a regulatory authority—the information is there. We maintain full traceability from raw materials to finished units, supported by auditable documentation that substantiates every quality-related decision. This documentation framework forms the foundation for product registration and importation in your target market, in coordination with our regulatory affairs and product registration services.
Frequently Asked Questions
Under the FDA’s Current Good Manufacturing Practices (cGMP) for dietary supplements, as set forth in 21 CFR Part 111.
Yes. Each batch is accompanied by its Certificate of Analysis (CoA), which documents its compliance with the established specifications.
Yes. We conduct studies in accordance with internationally recognized guidelines, including accelerated conditions, to support the product’s shelf life.
Yes. It is the documentary basis that supports the sanitary registration and importation into the destination market.
