Quality Supervision Of Drug Production Processes

With the enhancement of social development and people's health concept,and drug safety issues are paid more and more attention,the quality of the drug will have a direct relationship with people's life safety.In recent years,the medical accident caused by the drugs production quality caused serious damage to the whole society.How to effectively protect drug safety and avoid the quality accidents of pharmaceutical production to occur again,has become a major issue faced by the whole society.With the 2008 State Council institutions adjustment,food and drug supervision and Management Bureau of the Ministry of health of China's return to management,the changes about the medicine management system in ten years reflects the difficulties of constructing is the drug supervision and management system in China,the pharmaceutical producing enterprises as the first responsible for drug safety quality responsible persons,the blame on production quality accidents frequent drugs,at the same time as the drug approval to enter the market of public regulators have an unshirkable responsibility.Have been sacked and drug supervision of senior staff in recent years,pharmaceutical production quality management through the"counterfeit drug enterprises"(GMP)certification,all exposed the existence of our drug regulatory system,mechanism of vulnerability.This paper is based on the drug safety production supervision in the process of Chinese as the core chapters,using normative analysis,comparative analysis and other methods,based on the quality of the drug tube,system management,information management and risk management to fully research on the related theories,draw lessons from the developed countries such as EU,USA drug safety production regulation experience the risk regulation,to introduce the concept of China pharmaceutical production work,and has carried on the systematic analysis.Based on the analysis of the chain through the establishment to explain why drug production safety accidents,so as to reduce drug production safety accidents,improve the drug production supervision system provides an optional ideas.Through systematic research we draw the following conclusion:first,the information communication mode in our country is not flexible enough,the public on the risk perception and communication and participation remains to beimproved;second,our country lacks the drug quality risk regulation guide system;third,to avoid drug production safety accident should improve the drug quality risk management awareness of pharmaceutical enterprises;fourth,regulators should strengthen the punishment for the producers and salers of illegal counterfeit drug.