Why Testing Methods Matter

In supplement manufacturing, FDA 21 CFR Part 111 (Current Good Manufacturing Practice for Dietary Supplements) and 117 (Preventative Controls for Human Food) set the foundation for quality products.

One key requirement is using scientifically valid test methods. If your finished product cannot be tested using a UV-Vis method because of co-ingredient interference, then your raw materials should not be tested by this broad method either.

For example, an “80% silymarins by UV” raw material might only show 40 to 50 percent when tested by HPLC, which measures specific markers against reference standards. If your finished product will need potency claims for silymarins, then you need to align with the testing that is possible and scientifically valid for the blend.

Best Practice: Testing and Qualification

The best practice is simple. Align your raw material specifications with your finished product specifications. Testing should start at purchasing, continue through research and development, and stay consistent during production. It should never wait until the end when the product is ready to ship.

A strong qualification program helps you align as well. Include identity checks such as HPTLC, potency testing, and screening for contaminants like heavy metals and microorganisms. If a supplier cannot meet these expectations, it is usually a sign to look for one that can. Quality products start with quality materials, and good science makes that possible.

Deliver Products You Can Stand by with Ara Testing Labs

At Ara Testing Labs, we understand the challenges manufacturers face with testing and compliance. Our team is ready to help you meet these requirements and deliver products you can stand behind. Contact us today to discuss your testing needs and let us be your trusted partner in quality.