CN

RESEARCH

QUALITY MANAGEMENT

Good Manufacturing Practice (GMP)
All manufacturers under Zhifei have established a comprehensive quality management system for pharmaceutical products in accordance with the Good Manufacturing Practice which covers the full life cycle from vaccine R&D, manufacturing, quality control, release to storage, shipment and after-sales service. And all organized and planned work are included to ensure that the product quality meets the intended purpose. Quality factors are managed through risk control to reduce or eliminate the influence of changes in the quality factors in the system on the product quality. The quality management system keeps continuous improvement through review, appraisal, self-inspection, deviation, change and CAPA to ensure that it satisfies GMP and other laws and regulations, thus providing high-quality products.

Good Supply Practice (GSP)
Zhifei is the first pharmaceutical enterprise that acquired 2013 GSP certification granted by the Chongqing Municipal Food and Drug Administration. Since its establishment, Zhifei has been adhering to the guideline “Quality First and Customer Oriented”, strictly abiding by national laws and regulations on drug administration and stringently implementing GSP provisions, so as to guarantee the robust functioning of its quality management system. With an integrated drugs distribution quality management system developed to consist of strict standardized management procedures covering procurement, transportation, warehousing, sales and after-sales services, Zhifei enables traceable recording of all operations. To secure the cold chain storage and transportation of vaccine products, Zhifei applies rigorous verification of all the refrigerated warehouses, refrigerated vehicles and cold roll boxes used. Other than that, all cold chain equipment is installed with a temperature monitoring system that keeps real-time records of temperature data, ensuring the stable, reliable quality of products during the storage and transportation process.