Superior Qualities and GMPs

Creating a superior supplement begins with quality ingredients. The raw materials used in Isotonix products undergo a comprehensive evaluation by our manufacturers to ensure that they meet stringent purity and potency requirements.

Verification and approval by a Certificate of Analysis (COA) is required for each raw material. Approved raw materials are subject to laboratory confirmation of physical characteristics and material potency, as well as analysis for microbiological contamination and heavy metals.

Each product is then carefully prepared following a written master manufacturing record, and every batch is reviewed and approved by quality control personnel. Products are inspected upon receipt for damage, label accuracy, appearance, taste and identity prior to release.

Each of our production facilities are required to meet GMP (Good Manufacturing Practice) standards. This means they are periodically inspected and approved by either the Food and Drug Administration or the United States Department of Agriculture for their strict adherence to Standard Operating Procedures, employee training, product specifications and supplier/vendor qualification procedures.

All manufacturing equipment that comes in contact with our products must be cleaned according to mandated procedures between production runs and verified to ensure sanitation has been performed prior to use. Product samples are also collected at various stages of production for chemical and microbiological analysis to ensure consistency and purity. Lot code confirmation, weight checks, label and material checks are performed according to exact written procedures.