Journal of Korean Society for Quality Management (품질경영학회지)

Korean Society for Quality Management (한국품질경영학회)
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A Study on the Efficacy and Equivalence of D-antigen Quantitative Analysis through QbD6sigma Process

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

  • 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)
  • 김강희 (LG화학 생명과학본부 6Sigma Master Black Belt) ;
  • 김현정 (전주대학교 경영대학 IT금융학과)
  • Received : 2022.10.06
  • Accepted : 2022.11.18
  • Published : 2022.12.31
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Abstract

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.

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