Study On The Medicine Safety And Quality Improvement For Traditional Chinese Medicine In X Enterprise

In China,the Traditional Chinese Medicine(TCM)has a long history and makes good progresses on the prevention and cure of illness.However,at present,there are frequent problems with TCM quality.Therefore,it has great significance to study how to guarantee the TCM quality,in order to be uniform,stable,safe and effective.Firstly,based on the analysis of the existing literature and the quality management of TCM manufacturers,this thesis explores the industry circumstance of TCM and its developing tend in the future.Secondly,Enterprise X and its one product called NDZ(A certain product code)injection are taken as research objects in order to improve the final medicine quality’s efficiency and safety.Through systematic analysis by using risk management tools,we find out the major common factors for the drug efficacy and safety in the processes of TCM modern industrialization and large-scale production.Furthermore,focusing on the quality management of TCM,the Whole Life-Cycle Quality Management System for TCM is built.Meanwhile,the key steps of quality control are recognized and corresponding quality control methods are put forward.At last,a practical case study is given to evaluate and verify the effectiveness of the proposed quality improvement methods.The results show,with the construction and implementation of the Whole Life-Cycle Quality Management System for the NDZ Injection in company X,the process quality is controlled and the products quality become uniform and stable.In addition,the application of the quality management system improves the risk management ability and brings high economic benefits.Meanwhile,the results are recognized and accepted by doctors,patients and the Chinese Government.Through the construction and practice of the Whole Life-Cycle Quality Management System for modern TCM products,this thesis provides a quality management system and related method to break the bottlenecks that hinders the TCM quality’s uniform,stable and safe.That has positive significance in promoting the enterprise management progress,the efficiency improvement and the development of Chinese medicine industry.