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http://dx.doi.org/10.7469/JKSQM.2022.50.3.373

A Study on the Build of a QbD Six Sigma System to Promote Quality Improvement(QbD) Based on Drug Design  

Kim, Kang Hee (LG Chem Life Science Division 6sigma Master Black Belt)
Kim, Hyun-jung (Department of IT Finance, College of Business Administration, Jeonju University)
Publication Information
Journal of Korean Society for Quality Management / v.50, no.3, 2022 , pp. 373-386 More about this Journal
Abstract
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.
Keywords
Quality by Design(QbD); Six Sigma($6{\sigma}$); Drug Design; Pharmaceutical Companies;
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Times Cited By KSCI : 5  (Citation Analysis)
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1 Amit S. Patil. and Anil M. Pethe. 2013. Quality by Design(QbD): A new concept for development of quality pharmaceuticals. International Journal of Pharmaceutical Quality Assurance 4(2):13-19.
2 Anurag S. Rathore. 2009. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends in Biotechnology 27(9):546-553.   DOI
3 Cho, S. W., Lee, H. S. 2022. A Study on the Common RPN Model of Failure Mode Evaluation Analysis(FMEA) and its Application for Risk Factor Evaluation. Journal of Korean Society for Quality Management 50(1):125-138.   DOI
4 Choi, S. B. 2021. The Compensation Gap between Top Management Team(TMT) and Employee, and Firm Performance : Moderating Role of Promotion Probability and Opportunity, and Satisfaction with TMT. Journal of Korean Society for Quality Management 49(3):313-326.   DOI
5 Gulin Amasya. 2019. QbD guided early pharmaceutical development study: Production of lipid nanoparticles by high pressure homogenization for skin cancer treatment. International Journal of Pharmaceutics 563:110-121.   DOI
6 Kim, K. H. and Ree, S. B. 2017. A Study on the Development of the Key Promoting Talent in the 4th Industrial Revolution - Utilizing Six Sigma MBB competency. Journal of the Korean Society for Quality Management 45(4):677-695.   DOI
7 Kim, K. H. and Ree, S. B. 2017. Suggested Shiny-Sigma method suitable for the shop floor. Journal of the Korean Society for Quality Management 45(2):227-246.   DOI
8 Kim, K. H. and Ree, S. B. 2020. A Case Study on QbD-6 sigma Method to the Pharmaceutical Department of L Company. ICIC Express Letters, Part B: Applications 11(5):501-508.
9 Lawrence, Y. 2018. Six Sigma Quality and Consortia. Pharmaceutical Engineering 38(6):8-10.
10 Lee, Y. G., Lee, H. J. 2021. Development of a New Similarity Index to Compare Time-series Profile Data for Animal and Human Experiments. Journal of Korean Society for Quality Management 49(2):145-159.   DOI
11 Sara Cunha., 2020. Using the quality by design (QbD) approach to optimize formulations of lipid nanoparticles and nanoemulsions: A review. Nanomedicine: Nanotechnology, Biology and Medicine, Volume 28, 102206.   DOI
12 Yim, H. S. 2018. Field of pharmaceutical bio industry. NeHa.
13 ICH Guideline Q8. Pharmaceutical Development.
14 ICH Guideline Q9. Quality Risk Management.
15 ICH Guideline Q10. Pharmaceutical Quality System.
16 ICH Guideline Q11. Development and Manufacture of Drug Substances.
17 ICH Guideline Q12. Lifecycle Management.
18 ICH Guideline Q13. Continuous Manufacturing of Drug Substances and Drug Products.
19 ICH Guideline Q14. Analytical Procedure Development.