The company's quality management system is directly led by general manager, including QC Dept. and QA Dept., exercise quality inspection and quality supervision and management functions respectively.

 

QC Dept. is responsible for quality test of raw materials, packing materials, intermediates, finished products, process water and environmental monitoring.

 

QA Dept. is responsible for establishing and strengthening quality management system, and setting full-time audit QA and on-site QA. Audit QA takes on-site audit for material supplier and collated the questionnaires, and on-site QA is responsible for on-site monitoring of manufacturing system, testing system and utility system. QA monitors the whole process from raw materials sourcing, warehousing inspection, manufacturing, testing, finished product release, sales and customer feedback, and also standardizes and improves quality management system. At the same time, the staff’s GMP understanding are improved through the daily inspection and periodic self-audit, and GMP trainings.

 

The company implemented GMP management in 2013, and passed national GMP certification in the same year. In the following years, Wuhan ZY pharmaceutical passed the domestic GMP certification for 2 times, and passed foreign customers audit for many times. Till now, all products (3 APIs) approved by CFDA have passed GMP inspection.

 

Quality Policy: Scientific management, continuous improvement; human-oriented, keep customer satisfied.

 

Quality Objective:

1.Keep and continuous improve GMP quality management system.

2.Qualified rate of product inspection is more than 99% at a time.

3.Personnel training rate reaches 100%.

4.Customer satisfaction is greater than 99%.

5.Staff’s quality objective is reflected in the job description.