The quality control system of Healthgen Biotech includes documents record management, quality management system running records, and records from suppliers.
To ensure our products meet high quality, Healthgen Biotech has well-experienced QA and QC teams.
QC is responsible for raw materials, packaging materials, intermediate products, finished product quality inspection and issue inspection report, and responsible for process water detection and issued report; and also in charge of the management of standard, reference and strains.
QA is responsible for monitoring of materials procurement, warehouse management, equipment management; monitoring of the production process; inspection of production record; supervision and monitoring of the inspection results; review; ensurance accurate implementation of the GMP document.
There are 14 employees in the quality department, 9 of them are in QA and 5 are in QA. All of them have experienced in pharmaceutical industry or biology industry for 4-15 years. Every year there are more than 50 training courses, which cover GMP, SOP, specification, hygiene, QA, QC issues, etc. Analytic instruments in QC are listed as below,
Equipment |
Origin |
Microplate reader |
Bio-Tek |
Osmotic pressure detector |
Tianjin SMC30C-1 |
Liquid Chromatograph |
Agilent |
Gas Chromatograph |
PE |
Kjeldahl apparatus |
Jinan K9840 |
RT-PCR |
ABI |
Karl fischer moisture meter |
Mettler Toledo |
Atomic absorption instrument |
PE |