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Quality Control

GMP LogoManufacturing Overview

WellSource Nutraceuticals® are produced in licensed manufacturing facilities that strictly adhere to current Good Manufacturing Practices (cGMPs). Products provided in tablet, capsule, and powder form are made in a manufacturing facility licensed by the State of California as a drug manufacturer and food processor and registered with the Food and Drug Administration as a drug manufacturing establishment. The facility is also approved by government agencies in the United Kingdom and the European Community (EC) to manufacture a drug product. Current GMPs and written standard operating procedures (SOPs) are strictly followed through all stages of production to produce products that meet or exceed United States Pharmacopeia (USP) standards.

NSF LogoWellSource Nutraceuticals’® manufacturing facility is NSF® GMP registered. NSF® is an independent, third-party inspection, testing, and certification company committed to public health and safety. The facility integrates this GMP registration with ISO 9001 to ensure GMP 9000 compliance.

Raw Material Specification

Active ingredients in WellSource Nutraceuticals’® products are selected based on purity, bioavailability, documented actions, and safety characteristics. Materials meeting USP standards are used for those nutrients where this standard exists. Raw materials are purchased exclusively from reputable vendors who provide detailed Certificates of Analysis for every lot of material. These certificates certify that active components, toxic elements, and microbial content are within specified acceptable parameters. Purity and potency of all raw materials are verified through independent testing laboratories by raw material vendors and WellSource Nutraceuticals®. All incoming raw materials undergo quarantine, inspection, evaluation, and identity testing by infrared spectroscopy. Purity and potency of all raw materials are verified through independent testing laboratories. Raw material vendors and third-party labs are routinely inspected by on-site audits for quality compliance by WellSource Nutraceuticals® quality assurance personnel.

medical staff working in a laboratoryQuality Control Laboratory Testing

On-site laboratory personnel evaluate physical characteristics of each finished product including hardness, disintegration, moisture balance, friability, and pH. Purity and potency of finished product is independently verified through outside commercial laboratories using randomized ingredient and batch testing program.

Excipients

WellSource Nutraceuticals® products are free of artificial flavors, preservatives, and colorings. Naturally derived, inert materials, including cellulose-based excipients, vegetable-derived magnesium stearate, L-leucine, and silicon dioxide are used in very small amounts as tableting and encapsulation aids. Tablets are protected with an inert, water-soluble cellulose coating that dissolves readily upon ingestion, thus facilitating disintegration time. Vegetarian capsules made of plant cellulose are used exclusively for two-piece encapsulated products. The following common allergens are avoided unless otherwise specified in ingredient listings: dairy, eggs, tree nuts, peanuts, wheat, yeast, and soy.

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.