The Quality Management In The New Drug R&D Projects Of HA Company

Since China’s reform and opening up, Chinese pharmaceutical industry has maintained fast growth, especially the biological pharmaceutical industry, as an emerging industry is in booming stage. The pharmaceutical industry is a special industry, involving national health, economic development and social stability, is closely related to People’s Daily lives. Because theory research and practice of quality management in medicine industry started late in our country, quality management of biopharmaceutical companies have a certain gap with the international first-line drug firms. Project quality management as a cross discipline of project management and quality management, is the soul of the project management. Pharmaceutical research and development (R&D) as an important support of medical product realization process, has a special role in the formation of drug quality. Pharmaceutical R&D in the project quality management has an important role, not only in the quality of the project itself but also in ensuring the quality of pharmaceutical products and the safety of the patients with medication, which has very important theoretical value and practical significance.This topic is about A project R&D of HA company’s, which is a biomedical R&D enterprise. Combining with the theory of total quality management (TQM), we focused project quality management risk control and application practice in R&D process, base on the five elements (man, machine, material, method, enviroment). Introducing the concept of total quality management, we analyzed the whole process of quality management, the total men of quality management and the whole methods of quality management in HA company. The problems and potential risks existing in the project quality management, especially how to improve the quality management of R&D project, shorten the development cycle and to ensure drug quality, were urgently needed to solve. For the two important quality events in A project of HA company, we found out the causes by using fishbone diagram and case analysis, and handled them by applying PDCA management cycle. Eventually, the two events about quality problem gained good effective solution, and some management experiences were accumulated. According to their own characteristics of biopharmaceutical project, we formulated a series of rules and standards for management, and continuously improved quality system using PDCA cycle. A set of simple quality management system suitable for the HA company was established.In a word, total quality management theory in the practice of HA company achieve good results, greatly shortening the development cycle and saving the cost of the product R&D. Safe, effective, stable, homogenous and qualified products are finally successfully completed in A project, which enhance the core competitiveness of enterprises.