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Quality registration

Quality Management

 

The company implements cGMP management, and has set quality assurance department (QA) and quality control department (QC)  under quality management department, which exercise the function of quality supervision, management and quality inspection respectively. The total number of employees in quality management department is more than 120, accounting for about 15% of the total number of employees in the company.

 

Quality assurance department (QA) is responsible for the company's GMP management, and their main job is file management, validation and confirmation, GMP training, supplier audit, handling of complaints and adverse reactions, change control, deviation control, the annual  review and analysis of product quality, nonconforming product control, label management, product release, GMP self-inspection, corrective and preventive actions, etc.

 

Quality control department (QC) is responsible for material sampling, inspection, sample keeping, intermediates release, raw and auxiliary materials, investigation of the stability, method validation/confirmation, etc.

 

The company attaches great importance to product quality, and has passed the GMP certification and registration of CFDA in China ,FDA in USA ,  MHRA in UK, COS in EU,  PMDA in Japan, KFDA in South Korea, and Slovenia etc.