The Design And Implementation Of Good Manufacturing Practice Management System For Pharmacy

Pharmaceutical industry, an important source of revenue, occupies a vital position in national economy in China. Under the circumstance of the economic globalization and the competition at home and abroad, especially after entering the WTO, the management of materials and quality is needed in pharmaceutical industry to improve its business. GMP is a special management system, attaching importance to the quality and safety of the product in the production process. It is a compulsory standard applied to pharmaceutical and food industry. Enterprises are required to formulate norms to help improve the sanitary environment and to find and solve problems in the production process according to the national rules and laws. In brief, GMP requires that enterprises should be equipped with excellent facilities with reasonable production process, and improve the quality management and strict detecting system to ensure the quality of final products. On the basis of the existing thought of GMP quality management, this paper devises a GMP quality management system targeting the pharmaceutical industry with the analysis of the actual demand and business process.Firstly, on the basis of the background of the GMP and the problems in its devising and developing, the paper analyzes the functional requirement and non-functional requirement of the system with flowcharts.Secondly, the design of the system is based on the analysis of demand. The target and principle are put forward according to the demand of the system, and then the technical and functional architecture are devised respectively. Stratified model architecture is adopted considering the expansibility, maintainability and performance of the technical architecture. In the design of the functional architecture, the function of each part of the system is under discussion.Then, the paper focuses on the GMP quality management system targeting pharmaceutical industry. The designing concept of each module is described. In this part, the information system is introduced in brief statements. Then the structure chart is put forward and the design of each module is under discussion according to the design concept.Next, the realization of each module is discussed briefly. More emphasis is put on core technology and performance analysis.Finally, the application of this system is introduced in brief. Suggestions for further improvement are brought forward.To sum up, the GMP quality management system is devised and realized based on the analysis of the business demand and management concept.