Analysis Of Quality Risks And Supervising Countermeasures On Injection

The problem of drug safety is important to the people’s livelihood and public security, which is related to people’s health, social harmony and stability. With the progress of society, the improvement of people’s living standard, people pay more and more attention to the problem of drug safety. In this case, to ensure the manufactuing quality of drugs, to analysis the cause of the contaminated events and minimize the impact, to prevent it from happening once again are becoming the primary task of drug regulatory departments to guarantee drug safety level and safeguard the people’s health.As a high-risk product, the injection product needs high requirement of manufacturing operation, especially non-sterilization product including lyophilized powder. It requires non-sterilization environment, the operations of machines and facilities need follow strict discipline. To make sure the functions well is a huge challenge. The way how to made QRM effectively in both government agencies and manufactures is a real question worth attention.The study was divided into five parts, the first chapter described the background of using of QRM in supervision agency. It introduced foreign advanced supervise policy and domestic supervise policy, then elaborated why we need push risk management policy expeditiously.Chapter2took the lyophilized powder workshop with the research object, and used the risk method of FMEA, HACCP to find out the real problems occured during the risk analysis in manufacturing enterprise.In chapter3, it took the case of failures in product sterility assurance, and made a research to find out a way to control risk with the method of fishbone diagram and Fault Tree Analysis in supervision agncy. It made a discussion how to make an effective risk communication between supervision agency and manufacturer, as well as,how to define the risk rank of manufacturer.The forth chapter discussed the lack of risk control ability in regular inspection, and some problem in the supervision inspection management. According to the problems in the regular inspection, it propose a method of check list to manage potential inspection risk. We hope that this study can promote the risk control of supervison.In chapter5, development of quality risk mangment was discussed and related issues were thought deeply.