Study of HY Quality Risk Management System
|Keywords||HY pharmaceutical drug quality management risk management|
The quality control and management in pharmaceutical industry must comply with the GMP standards. As more and more averse events occur in the society, pharmaceutical industry has to pay more attention to the quality risk management. Minimization of risk is a new and prominent concept which becomes a positive supplement of the GMP management. The manufacture and the usage of drug bear certain level of risks and quality risk is just one of risks. It is important to understand that quality must be monitored throughout the drug lifecycle in order to keep the drug effect consistent with that in the clinic research.The background, international and domestic progress, content and method of this research are presented in the first chapter. Then the principles of quality risk management are discussed, such as the drug quality risk management principles. HY quality management situation is then analyzed and the importance of quality risk management is emphasized. Each phase in the drug manufacture is analyzed and an effective system which is unique to HY is established. Cases of the application of the risk management system are shared to prove the suitability of this system. The knowledge in this article can serve as helpful experience for other pharmaceutical companies.