Ensuring your gummy supplements are potent and safe is a big deal for any brand that cares about quality. At KorNutra, we build that trust through rigorous, multi-stage testing in our GMP-compliant, FDA-registered facility. We verify every batch matches its label and stays free of contaminants.
Our Testing Protocol: A Layered Approach
Testing happens at every step, from raw materials to the finished product leaving our doors.
1. Incoming Raw Material Inspection
Quality starts with ingredients. Every shipment of vitamins, minerals, botanicals, and gelling agents like pectin goes through:
- Identity Testing: Using HPLC and FTIR to confirm the material is exactly what it claims to be.
- Potency Assay: Checking the active ingredient concentration against our specs.
- Contaminant Screening: Testing for heavy metals, pesticides, and microbes to catch issues early.
2. In-Process Quality Checks
During production, our techs constantly monitor temperature, pH, and mixing times. This ensures consistency and keeps active ingredients stable throughout cooking and depositing.
3. Finished Product Testing
The finished gummy passes through several release tests:
- Potency/Assay Testing: We analyze the gummy to confirm that all active ingredient levels sit within the specification range around the label claim.
- Stability Testing: Batches go into chambers with controlled temperature and humidity. We test them at 0, 3, 6, 12, and 24 months to confirm potency and sensory qualities (texture, taste, color) hold up over the shelf life.
- Microbiological Testing: A check for harmful bacteria, yeast, and mold.
- Heavy Metal Testing: A final screen for lead, arsenic, cadmium, and mercury.
- Physical & Sensory Analysis: We evaluate texture, flavor, color consistency, and check for any defects.
What 21 CFR Part 111 Requires
Testing is not optional. Dietary supplement manufacturers operate under 21 CFR Part 111, the cGMP rule, and its finished-product testing requirements sit in section 111.75. The rule requires a manufacturer to verify that finished batches meet product specifications for identity, purity, strength, composition, and limits on contaminants that may adulterate the product. A maker can test every batch or verify a subset through a sound statistical sampling plan. Identity testing of incoming dietary ingredients is required before use; a supplier's CoA is not enough on its own.
When you evaluate a manufacturer, confirm that its protocol maps to these requirements. Ask which specification each test supports and whether the CoA reports methods and numeric results against limits, not just a pass line. A CoA documents one batch's results; it does not replace the underlying quality system or GMP compliance.
Documentation and Transparency
Every batch gets a Certificate of Analysis (CoA) that documents all test results. A complete CoA lists each test, the method, the numeric result, and the specification limit. Reputable manufacturers share this with their brand clients, and it shows the batch met its identity, purity, strength, and contaminant specifications. When you're choosing a manufacturing partner, ask about their testing protocols and request a sample CoA.
This layered approach means every gummy supplement we produce matches its label and leaves our doors free of the contaminants we screen for.