Risk Management Research, Pharmaceutical Production And Quality Management System

Risk management principles are effectively utilized in many areas. But the quality risk management is an emerging field in the quality system of Pharmaceutical industry. Based on the regulatory requirements of quality risk management, the pharmaceutical enterprise need to learn and utilize it in order to make risk mitigation, reduce the harm and hazard, further to ensure the quality of the medicine.The actual article defined the quality system and the quality risk management. Indicating the principles of the quality risk management and clarify the relation of them. Examples cited with the DAK suppository manufactured by X company to make the research of the procedures and stpes in utilizing the quality risk management. Many tools will be used in the process. There also performed a comprehensive review about the quality to validate the risk management effective.