| As of August 18,2015,the Opinions of the State Council on the Reform of the Review and Approval System of the Drug Medical Device will improve the quality of the generic drugs and speed up the evaluation of the quality of the generic drugs as one of the five objectives of the reform and approval system of the drug review,and the consistency evaluation of the generic drugs has entered the public field of view.Quality management is an important activity to guarantee the quality of drug production,and plays an important role in the evaluation of generic drug consistency.The quality management idea is run through the whole evaluation process,so that the whole process of the generic medicine is ensured to be in accordance with the quality standard and has the curative effect consistency.This paper adopts the methods of enterprise investigation,interview and literature analysis.Through the study of the theories and methods of total quality management,risk management,quality originated from design and so on,combined with the method of PDCA cycle,This paper interprets the quality management requirements of generic drug consistency evaluation at home and abroad,analyzes the development of generic drug consistency evaluation project in Tianan Pharmaceutical Industry and the current situation of quality management,and summarizes the existing problems and the causes.For Tianan Pharmaceutical Industry to improve the level of quality management to provide a strategic choice.Through the research and analysis,the consistency evaluation of the generic drug is an industry reshuffle,and the evaluation of the consistency of the generic drug is a great impact on the domestic pharmaceutical industry,which is the process of the fittest of the pharmaceutical enterprise.The consistent evaluation of the generic drug in Tianan Pharmaceutical Industry is to seize the first machine in the process of remolding the industry,and based on the diabetes drug market,this is the opportunity of Tianan Pharmaceutical Industry,and it is also a great challenge.Secondly,the quality management of Tianan Pharmaceutical Industry is not perfect,the product trial production cost is high,the deviation of the quality system is on the rise,and the risk identification evaluation is not in time.In order to improve the quality management level of Tianan Pharmaceutical Industry,this paper considers that combined with total quality management,quality originated from design and other quality theories,the strategic analysis and selection of the improvement of quality management level have been carried out.It is suggested that the PDCA cycle should be combined with the quality management work,so as to make the quality design of the product R&D through the combination of the quality originating from the design and the conformity evaluation project of the generic drugs,so as to achieve the normal quality management and the information-based data management.Technology transfer and process execution are guaranteed by quality system.Finally,through the guarantee of human resources,enterprise strategy and hardware facilities,the organizational structure of quality management is optimized and the quality performance is established.Management measures to form the quality culture of the enterprise and build the hardware facilities necessary for the development of the enterprise.This paper takes the present situation of quality management in Tianan Pharmaceutical Industry as the research object,through analyzing the existing problems,puts forward the strategy of improving the quality management,in order to improve the quality management level and ensure the smooth development of the evaluation of the consistency of generic drugs.Tianan Pharmaceutical Industry as a small and medium-sized pharmaceutical enterprises,this paper has important significance for its development.At the same time,it can be used for reference to enterprises of the same size in the same industry. |
PDF Full Text Request