T Pharmaceutical Company Internal Quality Management Improvement Studies

Since the GMP98version implemented, Chinese pharmaceutical industry has mademuch progress in quality management generally. However, most domestic drugmanufacturing enterprises are small, and the implementation of GMP started later thanoverseas, which leads to the lag of Europe and US. On March1,2011, GMP new version(Good Manufacturing Practice of2010version) published and implemented, standards andrequirements have increased greatly than GMP98version, the quality management ofpharmaceutical company would be pushed to a new level. The whole industry especiallysmall and medium-sized manufacturing enterprises will face to the pressure and drivingforce of the development of the integration.T pharmaceutical company is a private small and medium-sized production enterprise,mainly produces solid dosage forms, in accordance with GMP98version’s qualitymanagement, and passed GMP98version certification. In the face of the new higherrequirements of GMP, combined with its own quality management problems that exist inthe implementation process, T pharmaceutical company must think its qualityimprovement strategies, prevent the production quality problems, and make products morecompetitive, to promote the enterprise development quickly.On the basis of the analysis of existing problems, according to the theory of totalquality management, PDCA cycle model, etc., combining with the actual situation andregulatory requirements, it is concluded that T pharmaceutical company must build aquality system based on GMP new version concepts. Then, according to the analysis of thecause of the problem, puts forward the detailed work plan and specific measures. Theresearch of this article has realistic meaning and value to ensure the quality ofpharmaceutical production and people’s safety, and also has a certain reference significanceto other domestic private small and medium-sized pharmaceutical enterprises qualitymanagement and quality improvement.