Study The High-risk Drug Quality Control Mode In The Manufactory Of China

As special products, how to effectively ensure drug’s quality since R & D to being used is the critical effect for safety and healthy of human beings. And the most important of all is the quality control of pharmaceutical production processes. It is very useful to assurance the quality and safety of medicines in production processes in order to prevent the occurrence of adverse drug reactions or damage events. However, a small part of pharmaceutical manufacturers produce substandard medicine, cause a number of serious adverse reactions and injury events in recent years. How to establish effective quality management system of drug production in pharmaceutical manufactories, has been an important problem to government in our country.The study attempts to refer the international biological products batch release regulations, select the batch release model of human serum albumin injection which belongs to blood products, for example. Analysis the model of batch release, meanwhile combined with the regulations of GMP, HACCP and Risk assessment. To propose a technical management mode for high-risk drug quality control in pharmaceutical manufactories, and also for the administration. Here management means two aspects:supervision over enterprises by administration, production process quality control of pharmaceutical companies.The study use the methods includes:①Literature research,②Regulation research,③Site investigation,④Logical analysis, comparative analysis,⑤Conventional mathematical statistics and risk assessment software. The results show that the management of high-risk drugs production in our country exist many problems in scientific, systematic and continues aspects. Comparing with the high-risk drug management system of United States and European Union, there is still a certain gap. In our country, Manufacturing enterprises still lack of quality awareness and risk awareness. Government departments lack of regulatory professionals, and the technical requirements or detailed technical basis to checking pharmaceutical manufacturing process. So that quality control of pharmaceutical production process becomes a mere formality sometimes.In this paper, specific case studies of different types of pharmaceutical production process quality control conditions, compared to the typical process control mode of human serum albumin. Found that some blind area in quality control of production process exists. And lack of technical methods to control and supervision. The final result of the study is that establishes an initial production process quality management model. The enterprises take main responsibility and manage the whole process of production quality effectively. Meanwhile, the government department could supervise and inspect according to the record and procedures from the quality control system of pharmaceutical manufactories.