Je Vaccine Pharmaceutical Projects, Quality Management, Applied Research

The first quality concern of a biopharmaceutical product is its safety and efficacy. Thus requires that the whole production procedures must comply with the requirements of Good Manufacturing Practice (GMP). To realize the quality product manufacturing, an enterprise has to invest huge resources on production engineering project. The quality of an engineering project is not only impacting the product realization and survival of a company, but also concerning the health and safety of people. Therefore, it is of significant practical meaning to reinforce the quality management of engineering projects.This article was focusing on systematic quality management of Japanese Encephalitis vaccine facility project, conducted primary study on methodology of improving the project quality management. The article explained the current situation of quality management for biopharmaceutical engineering project and the theories and methods of quality management, analyzed differences of quality and risk management between domestic and foreign projects, then introduced the advanced theories and methods of quality management. And combining the specific requirements of JEV project quality management, the quality management strategies and flows for this project has been set up. This article also introduced the implementation of quality validation system in different stages of JEV project, quality control and risk management on critical system of this project. All these managements have allowed the project to meet with the quality requirements. Samples from this project have been presented to show the quality management status of this project.Based on the practice of the above-mentioned methodology, this article provided a simple, efficient and controllable quality management methods to solve the following issues in quality management of biopharmaceutical engineering projects: (1) providing practical and implementable quality management methods; (2) setting up quality management procedures to standardize the quality management ; (3) decreasing the quality risk via critical system impact analysis; (4) the project is a typical biopharmaceutical project and achieved good results, which will provide guidance and model for the quality management of similar project in future.