Shanghai Zerun Biotechnology Co.,Ltd

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Manufacturing and QM System

Zerun has a pilot plant capable of producing clinical trial samples under cGMP condition, and a commercial manufacturing plant with an initial capacity of 15 million doses a year.

Zerun regards quality as the life and soul of the company and its products. Not only does Zerun strictly adhere to all relevant quality laws and regulations, but also does the company ingrain “quality culture” throughout product life cycle starting from research, development, manufacturing to product after launch. 

R&D Quality system
The system ensures that procedures are standardized, and to have clear process definitions and straightforward quality control plans that simplifies work and create new time for real innovation rather than procedures that stifle their creative ideas. This helps to reduce the development cycle time which helps in developing a new product faster than those of competitors.

Manufacturing quality system
The manufacturing quality system is based on the domestic and international guidelines including those from CFDA, ICH, WHO, MHRA and US FDA.