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KMID : 0369820070370060329
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 6 p.329 ~ p.338
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Development of Process Analytical Technology (PAT) for Total Quality Innovation on Pharmaceutical Processes
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Shin Sang-Mun
Park Kyung-Jin
Choi Yong-Sun
Lee Sang-Kil
Choi Guang-Jin
Kwon Byung-Soo
Cho Byung-Rae
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Abstract
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The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.
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KEYWORD
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Micro & Nano design of experiment(DOE), Process analytical technology(PAT), Pharmaceutical process, Quality innovation, Information technology, Good manufacturing practice(GMP)
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