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.
Highlights
The process industries are those industries where the primary production processes are either continuous, or occur on a batch of materials that is indistinguishable
Near infrared (NIR) and mid infrared (MIR) spectroscopy have been recommended as the most popular spectroscopic tools for predicting quality of diesel/biodiesel blends, and the former has been used as an analyzer to determine the effect of key operating conditions on recovery, selectivity, and productivity for production [3]. It will take 2 hours to check aluminum-plastic packaging according to the methods in European pharmacopoeia, but only 2 min is needed by near infrared (NIR) analysis
Custom Sensors & Technology is a company that can supply a GMP compliant light-induced fluorescence (LIF) sensor to address a wide range of fluorescent process analytical problems - in particular tumble blending within the pharmaceutical industry
Summary
The process industries are those industries where the primary production processes are either continuous, or occur on a batch of materials that is indistinguishable. Near infrared (NIR) and mid infrared (MIR) spectroscopy have been recommended as the most popular spectroscopic tools for predicting quality of diesel/biodiesel blends (density, sulfur content, and distillation temperatures), and the former has been used as an analyzer to determine the effect of key operating conditions on recovery, selectivity, and productivity for production [3] It will take 2 hours to check aluminum-plastic packaging according to the methods in European pharmacopoeia, but only 2 min is needed by NIR analysis. The number of papers about PAT & PAC indexed in Web of knowledge during the last 20 years.(Keywords including "process analytical technology", "process analytical chemistry", "process analytical technique", "on-line analysis in pharmaceutical", "real-time monitoring in pharmaceutical" and "process control in pharmaceutical"). Table 1. worldwide PAT methods and their usage percent [4]
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