QUALITY AND SAFETY
Time of issue:2020-03-11 00:00:00
- Time of issue:2020-03-11 00:00:00
Strictly in accordance with Chinese GMP（2010 version）, guidelines issued by FDA、EDQM, and ICH relevant regulations, we have established a sound quality assurance system, implementing regular supervision and management in overall process of drug production.
We set up professional Regulatory Affairs dept, which is responsible for editing DMF of our products in CTD format as ICH regulated and submit to relevant authorities. Special person is assigned to take charge of tracing domestic and overseas regulation trends to make our company conform with all kinds of regulations at any time.
We have set an independent quality management dept.–Quality Assurance dept., which directly reports to general manager, and is responsible for the whole quality management.
Our staffs have rich quality management experience. We can make accurate judgment and correct treatment to deal with quality problems in production process, perform supervision function, handle with all quality related affairs, evaluate and review all files system. Make sure that goods from raw materials to finished productions and even delivering to clients could be controllable and traceable. Our QA team positively responds to company concept of export-oriented development. Pushes forward advanced cGMP management, sets about getting domestic or foreign GMP authentication and prepares for various grades of customer’s site audit. We always pay close attention to and satisfy clients’ needs. Supply steady quality goods and superior service for our customers, and continuously improve comprehensive strength to lay a solid foundation for our sustainable development.
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