품질경영학회지 (Journal of Korean Society for Quality Management)

  • 제50권4호
  • /
  • Pages.831-842
  • /
  • 2022
  • /
  • 1229-1889(pISSN)
  • /
  • 2287-9005(eISSN)
한국품질경영학회 (Korean Society for Quality Management)
권호 표지
DOI QR코드

DOI QR Code

QbD6시그마 프로세스를 통한 D-항원 정량 시험법의 유효성과 동등성에 관한 연구

A Study on the Efficacy and Equivalence of D-antigen Quantitative Analysis through QbD6sigma Process

  • 김강희 (LG화학 생명과학본부 6Sigma Master Black Belt) ;
  • 김현정 (전주대학교 경영대학 IT금융학과)
  • Kim, Kang Hee (LG Chem Life Science Division 6Sigma Master Black Belt) ;
  • Hyun-jung, Kim (Department of IT Finance, College of Business Administration, Jeonju University)
  • 투고 : 2022.10.06
  • 심사 : 2022.11.18
  • 발행 : 2022.12.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Purpose: This study carried out the Quality by Design (QbD)6σ process to verify the effectiveness and equivalence of the finished D-antigen quantitative test method, and compared the OFAT-based method validation and test result acceptance criteria with the Analytical Quality by Design (AQbD)-based method validation and test method. This is a study on how to reduce the risk of delay in permit change by increasing the reliability of permit data in the existing method by statistically analyzing the results. Methods: With the QbD6σ process, the effectiveness and equivalence of the D-antigen quantitative test method were verified with the data of the existing test method and the new test method. Results: Method validation tests are performed based on AQbD. Critical Method Parameters are identified through risk assessment, and single/combined actions are verified by designing and performing tests for Critical Method Parameters (analysis of variance, full factorial design method). Method validation can be effectively accomplished with the QbD6σ process. Conclusion: The use of QbD6σ can be used to achieve satisfactory results for both pharmaceutical companies and regulators by using appropriate statistical analytical methods for method validation as required by regulatory agencies.

키워드

참고문헌

  1. 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. https://doi.org/10.7469/JKSQM.2022.50.1.125
  2. George L. Reid,. James Morgado. 2013. Analytical Quality by Design (AQbD) in Pharmaceutical Development. American Pharmaceutical Review. August 27.
  3. Helen Yarovoi., Tina Frey. 2013. Quality by design for a vaccine release immunoassay : a case study. Bioanalysis 5(20):2531-2545. https://doi.org/10.4155/bio.13.198
  4. ICH Guideline Q10. Pharmaceutical Quality System.
  5. ICH Guideline Q11. Development and Manufacture of Drug Substances.
  6. ICH Guideline Q8. Pharmaceutical Development.
  7. ICH Guideline Q9. Quality Risk Management.
  8. Kim, K. H. 2018. A Study on problem solving methodology suitable for field and innovation specialists -Focusing on L Company Six Sigma activities, Doctoral dissertation in business administration.
  9. Kim, K. H., and Kim, H. J., 2022. A study on the build of a QbD six sigma system to promote quality improvement(QbD) based on drug design. Journal of the Korean Society for Quality Management 50(3):373-386.
  10. 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. https://doi.org/10.7469/JKSQM.2017.45.4.677
  11. 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. https://doi.org/10.7469/JKSQM.2017.45.2.227
  12. 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.
  13. Lawrence, Y., 2018 Six Sigma Quality and Consortia. Pharmaceutical Engineering 38(6):8-10.
  14. 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. https://doi.org/10.7469/JKSQM.2021.49.2.145
  15. Seo, H. J,. Byun, J. H., 2021. Quality 4.0: Concept, Elements, Level Evaluation and Deployment Direction. Journal of Korean Society for Quality Management 49(4):447-466. https://doi.org/10.7469/JKSQM.2021.49.4.447
  16. USP1033 Biological Assay Validation.
  17. USP1034 Analysis of Biological Assays.
  18. Yim, H. S., 2018. Field of pharmaceutical bio industry. NeHa.