Lipogen follows the highest quality standards in manufacturing its products. In fact, the company undergoes quality control audits equivalent to pharmaceutical companies, covering all manufacturing stages, end to end. This strict process begins with the sourcing and production of raw materials and continues through to the finished product, including testing in an independent external laboratory. Before any product leaves our facility, it has been approved to meet our standards of excellence.
Here are the primary systems we use and the standards we follow across the quality assurance spectrum.
Meeting international standards for air filtration, Lipogen processes air that circulates in its production areas through a bank of HEPA (high efficiency particulate air) filters that remove airborne particles. Air quality is routinely tested in Lipogen's in-house laboratory.
Lipogen does not use dangerous solvents in its product manufacturing. This natural approach and Lipogen's use of clean water minimize contamination and make for healthier products. Water samples are routinely verified for purity in Lipogen's testing laboratory.
Lipogen uses food-grade cleaning-in-place (CIP) cleaners to sanitize equipment between batches, as required by FDA, EMEA, GAMP, cGMP and HACCP (Hazard Analysis and Critical Control Points) standards. Cleaners used are environmentally friendly and many cleaning components are recycled to preserve the environment.
Lipogen formulas and ingredients are produced in a facility certified by ISO (International Standards Organization), conforming to international standards that promote the manufacture of products that are safe, reliable and of good quality, while minimizing errors and waste.
Complying with international Good Manufacturing Practices (GMP), Lipogen production facilities adhere to comprehensive standards for quality in manufacturing, control, human resources, administrative support, etc.
Lipogen products are Generally Recognized As Safe (GRAS) according to U.S. FDA standards. To obtain this approval, Lipogen submitted a comprehensive product safety portfolio, and the FDA reviewed Lipogen's scientific information, clinical trial results and toxicology reports demonstrating safety.
Lipogen products are certified as kosher. Lipogen follows the strictest laws of kosher observance.
Lipogen has earned the distinguished Novel Food authorization for safety from the European Commission. Comprehensive reviews cover product composition, characteristics, production, risk factors, stability, exposure, toxicology and use.
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