Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Development of Process Analytical Technology (PAT) for Total Quality Innovation on Pharmaceutical Processes

의약품 제조공정에서의 전사적 품질혁신을 위한 공정분석기술 개발

  • Shin, Sang-Mun (Department of Systems Management & Engineering, Inje University) ;
  • Park, Kyung-Jin (Department of Systems Management & Engineering, Inje University) ;
  • Choi, Yong-Sun (Department of Systems Management & Engineering, Inje University) ;
  • Lee, Sang-Kil (Department of Pharmaceutical Engineering, Inje University) ;
  • Choi, Guang-Jin (Department of Pharmaceutical Engineering, Inje University) ;
  • Kwon, Byung-Soo (Department of Pharmaceutical Engineering, Inje University) ;
  • Cho, Byung-Rae (Department of Industrial Engineering, Clemson University)
  • 신상문 (인제대학교 시스템경영공학과) ;
  • 박경진 (인제대학교 시스템경영공학과) ;
  • 최용선 (인제대학교 시스템경영공학과) ;
  • 이상길 (인제대학교 제약공학과) ;
  • 최광진 (인제대학교 제약공학과) ;
  • 권병수 (인제대학교 제약공학과) ;
  • Published : 2007.12.21
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Abstract

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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References

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