Genesis Nutriceuticals Quality Assurance

 

Quality Control

Genesis Multinutrient is produced in an FDA approved facility that is GMP Certified (Good Manufacturing Processes-When a supplement company is GMP certified, a government comes out to check the manufacturing plant and production processes to insure safety of the consumer.

All raw materials to be utilized by Genesis Nutriceuticals are required to have a Certificate of Analysis which meets our manufacturer’s raw materials specifications. Following receipt of a material, which meets their strict purchasing requirements, the material is tested by organoleptic means, (involving taste, color, odor and feel. Organoleptic testing involves inspection through visual examination, feeling and smelling of products), and Fourier Transformation Infrared Analysis (FT/IR). Raw materials are tested, as required, for microbiological contamination utilizing an automated Solaris microbiology analyzer, and heavy metal contamination with the assistance of Inductively Coupled Plasma Optical Emission Spectroscopy (ICP/OES).

The manufacturing process is conducted through a Batch Production Record,
and under the guidance of Standard Operating Protocols. A portable ATP (Adenosine TriPhosphate), testing device monitors all portions of in-process manufacturing for microbiological contamination. All manufacturing steps are monitored by Quality Assurance for appropriate weights, measures, conformity to process, and batch record guidance.

Every batch of finished goods leaving our facility is tested by FT/IR for conformity. Following, every batch is tested to insure it is free of microbiological contamination (Solaris) and every batch is tested by ICP/OES to insure it is free of heavy metal contamination. In the lab, TG/DTA (ThermoGravemetric / Differential Thermal Analysis), is used for stability. High Performance Liquid Chromatography (HPLC), Ultraviolet / Visible Spectroscopy (UV/Vis), Gas Chromatography (GC) and an Autopol II Automatic Polarimeter are used for measuring purity and contamination. Thin Layer Chromatography (TLC) is the chosen methodology for herbal identification.

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