의약품 설계 기반 품질 고도화(QbD)를 위한 QbD 6시그마 체계 구축에 관한 연구

• Published in: 品質經營學會誌 Vol. 50; no. 3; pp. 373 - 386
• Main Authors: 김강희, Kim Kang Hee, 김현정, Kim Hyun-jung
• Format: Journal Article
• Language: Korean
• Published: 한국품질경영학회 30.09.2022
• Subjects: Drug Design; Pharmaceutical Companies; Quality by Design(QbD); Six Sigma(6σ); 학제간연구; Six Sigma( $6{\sigma}$); Quality by Design(QbD); Drug Design; Pharmaceutical Companies
• ISSN: 1229-1889; 2287-9005
• DOI: 10.7469/JKSQM.2022.50.3.373

Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.