The Development of PAT (Process Analytical Technology) for Drug Production and the Requirements for Domestic Pharmaceutical Engineering Education

Abstract

After decades of practice and development, the GMP of drug production has entered the cGMP (Current Good Manufacturing Practice) era. In 21st century, PAT has become one of the new trends in the reform of the United States cGMP. In order to learn from foreign pharmaceutical quality control and production management experience, in this paper, the concept of PAT was introduced, the background of drug production PAT and its significance, the development trends of domestic pharmaceutical production PAT were reviewed. The domestic pharmaceutical engineering education under the new situation of PAT was discussed with emphasis. It was pointed out that to meet the requirements of the development of PAT, China's pharmaceutical engineering education needs constant adjustment and reform.