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
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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.
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.
참고문헌 (18)
- 조성우, "위험 요인 평가를 위한 FMEA의 일반 RPN 모형과 활용에 관한 연구", 품질경영학회지, 50(1), pp.125~138 (2022), 한국품질경영학회[DOI]
- George L. Reid, "Analytical Quality by Design (AQbD) in Pharmaceutical Development", American Pharmaceutical Review (2013)
- Helen Yarovoi, "Quality by design for a vaccine release immunoassay : a case study", Bioanalysis, 5(20), pp.2531~2545 (2013)
- "ICH Guideline Q10. Pharmaceutical Quality System", ~
- "ICH Guideline Q11. Development and Manufacture of Drug Substances", ~
- "ICH Guideline Q8. Pharmaceutical Development", ~
- "ICH Guideline Q9. Quality Risk Management", ~
- Kim, K. H., "A Study on problem solving methodology suitable for field and innovation specialists -Focusing on L Company Six Sigma activities", Doctor, pp.2018
- 김강희, "의약품 설계 기반 품질 고도화(QbD)를 위한 QbD 6시그마 체계 구축에 관한 연구", 품질경영학회지, 50(3), pp.373~386 (2022), 한국품질경영학회[DOI]
- 김강희, "A Study on the Development of the Key Promoting Talent in the 4th Industrial Revolution - Utilizing Six Sigma MBB competency-", 품질경영학회지, 45(4), pp.677~696 (2017), 한국품질경영학회[DOI]
- 김강희, "현장에 적합한 샤이니-시그마 기법 제안", 품질경영학회지, 45(2), pp.227~246 (2017), 한국품질경영학회[DOI]
- Kim, K. H., "A Case Study on QbD-6 sigma Method to the Pharmaceutical Department of L Company", ICIC Express Letters, Part B: Applications, 11(5), pp.501~508 (2020)
- Lawrence, Y., "2018 Six Sigma Quality and Consortia", Pharmaceutical Engineering, 38(6), pp.8~10 (2018)
- 이예경, "동물 및 임상 시험의 시계열 프로파일 데이터 비교를 위한 유사성 지수 개발", 품질경영학회지, 49(2), pp.145~159 (2021), 한국품질경영학회[DOI]
- 서호진, "품질 4.0: 개념, 요소, 수준 평가와 전개 방향", 품질경영학회지, 49(4), pp.447~466 (2021), 한국품질경영학회[DOI]
- "USP1033 Biological Assay Validation", ~
- "USP1034 Analysis of Biological Assays", ~
- Yim, H. S., "Field of pharmaceutical bio industry" (2018), NeHa