Quality
Syndion is manufactured under Good Manufacturing Practices (GMP) standards at an FDA inspected facility in the US, and is tested by an independent laboratory (not affiliated with Yasoo Health or the production facility) for quality and purity including heavy metal and GMO (genetically modified organisms) testing. All Syndion products are made from the highest quality raw materials.
What does “manufactured under GMP conditions” mean?
Good Manufacturing Practices (GMPs) are guidelines that outline the aspects of production and testing that can impact the quality of a product. The requirements include:
- Yasoo sends samples of all raw ingredients to an independent laboratory for analysis prior to use in manufacturing, to ensure identity, purity, strength, and composition of the ingredients.
- Following production, Yasoo then sends samples of the finished product to an independent laboratory for analysis before release of the product to determine whether the product met the established specifications.
- Yasoo Includes documentation in each batch production record, indicating that quality control personnel approved and released, or rejected, the batch for distribution.
- Any expiration date placed on a product label is supported by analysis and testing.
More specifically, our suppliers of raw ingredients are required to provide Certificates of Analysis (COAs) with each ingredient. We then send samples to an independent laboratory for testing prior to using the ingredients in a manufacturing run, to ensure their identity, purity, strength, and composition. YASOO Health rejects any component that does not meet specifications established for the production run.
The manufacturing is then done in an FDA inspected facility under Current Good Manufacturing Practices (CGMP) which strictly documents all aspects of the production run. GMPs are federal guidelines that outline the steps in production (manufacturing, packaging, labeling, and holding facilities) of a dietary supplement that can impact the quality of the product, and are established and enforced by the U.S. Food and Drug Administration (FDA).
Following the production run, samples of the finished product are then sent to an independent laboratory for analysis before release of the product for sale, to determine whether the product met the established specifications. YASOO includes documentation in each batch production record, indicating that quality control personnel reviewed, approved and released, or rejected, the batch for distribution. Any expiration date placed on a product label must be supported by analysis and testing. All Syndion products are also tested for heavy metals and genetically modified organisms (GMO).
All of these steps are cumbersome of time and resources, and significantly increase the cost of the product, but they are your assurance that the product you are purchasing is unadulterated and contains exactly what is listed on the label. Without appropriate documentation, you have no assurance of what is actually in a product. Companies may continue to operate outside of these standards (at least until they are inspected by the FDA), and their products may be less expensive for a while, but eventually they will need to either comply or cease operations. Make sure the dietary products you purchase are manufactured under CGMP and are tested for quality and purity. Would you want anything less for you or your child?
Our Quality Assurance personnel were certified by The Center for Professional Advancement (CfPA) in completion of the course GMP for Dietary Supplements.
To learn more about Dietary Supplement GMPs:
http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm110858.htm
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