Quality

Unigen’s Quality Assurance System

Unigen USA and Unigen Korea have a robust quality assurance system involving 9 QC/QA chemists and scientists, 6 high-powered liquid chromatography instruments, 2 high-powered thin layer liquid chromatograhy instruments, 2 gas chromatography-mass spectroscopy instruments, UV and Fourier transform infrared spec (FTIR) instruments, and a microbial lab. These are unique instruments that are utilized in addition to the common standard of basic analytical equipment.

Our goal is to ensure the identity, purity, strength and composition of every raw material used and every batch produced by Unigen, and to deliver the highest quality product possible.

At Unigen, quality assurance involves more than a single, periodical randomized test of the final product.  In this way, the ECONET companies' standard exceeds that of most mainstream pharmaceutical companies. At Unigen, quality assurance requires a systematic approach starting from the raw material, to every aspect of production, and carrying through to the final product release. Unigen has always implemented current good manufacturing practices (cGMP) in accordance with US standards for dietary supplements & pharmaceuticals in all operations.

For all raw ingredients, each ECONET company collaborates with qualified and certified vendors for raw material sourcing or  grows plants at its own farms through a vertically integrated system. ECONET conducts vendor audits on a regular basis. All farms practice Good Agricultural Practices (GAP). For every raw material provided, Unigen analyzes for potency and purity by using an elaborate "fingerprinting" technique. This technique involves  High Pressure Thin Layer Chromatography (HPTLC),  High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC) and/or other appropriate method. Unigen performs stringent tests to monitor for minor contaminates including microbes, heavy metals, organic solvent residues, and pesticides. The Quality department is involved throughout the production process, from monitoring procedures, to reviewing batch records and releasing the batches based on QC testing results and specifications. Standardization is used in production to ensure batch-to-batch consistency. When a product profile is discovered to be outside of specification, a lab investigation is conducted. We take quality-related complaints equally seriously. Corrective action and preventive action are enforced based upon the investigation outcomes. We are committed to the cGMP final rule and global regulations for the dietary supplement industry.

QC lab procedures include method development, method validation, stability studies, and support to pre-clinical and clinical studies. The testing method used is either an official method such as AOAC or USP, or is validated when developed in house. The reference standard used is qualified, the instruments used are calibrated, and the chemists are trained. We want to be sure that the results from our QC lab are reliable and reproducible.