ProThera® and Klaire Labs® brands of nutraceuticals are produced in licensed manufacturing facilities that strictly adhere to current Good Manufacturing Practices (cGMP's). 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 governmental agencies in the United Kingdom and the European Community (EC) to manufacture a drug product. Current GMP's and written standard operating procedures (SOP's) are strictly followed through all stages of production to produce products that meet or exceed United States Pharmacopeia (USP) standards.
Raw Material Specifications
Active ingredients used in ProThera® and Klaire Labs® brands of products are selected based on their purity, bioavailability, documented actions, and safety characteristics. USP materials (i.e. those 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 ProThera®, Inc. All incoming raw materials undergo quarantine, inspection, and evaluation.
Quality Control Laboratory
On-site laboratory personnel evaluate physical characteristics of each finished product including hardness, disintegration, moisture balance, friability, and pH. Identity testing using infrared spectroscopy (FTIR) is performed on all incoming raw materials. Purity and potency of each finished product is independently verified through outside commercial laboratories.
ProThera® and Klaire Labs® brands of products are free of artificial flavors, preservatives, and colorings. Naturally-derived, inert excipient 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. Tableted products are protected with an inert, water-soluble cellulose coating that dissolves readily upon ingestion, thus facilitating tablet disintegration time. Vegetarian capsules made of plant cellulose are used exclusively for two-piece encapsulated products. Common allergens such as wheat, corn, soy, yeast, and dairy are avoided unless otherwise specified on the label.