• 품질경영학회지
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• 제50권3호
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• pp.373-386
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• 2022

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.

• 품질경영학회지
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• 제50권4호
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• pp.831-842
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• 2022

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.

• 한국정보처리학회:학술대회논문집
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• 한국정보처리학회 2018년도 추계학술발표대회
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• pp.89-92
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• 2018

QbD(Quality by Design)는 제약분야에서 혁신적 신기술로 제조공정과 품질관리를 일원화하는 방법이다. QbD는 의약품의 품질을 높은 수준으로 향상시켜 제조공정 과정을 개선하여 효율성을 증대시키고 불량률 뿐만 아니라 공정 중 불필요한 장치의 가동을 최소화하여 비용을 절감시킬 수 있다. 본 논문은 제약분야에서 QbD 적용의 필요성에 따라 에지 컴퓨팅 기반 QbD 플렛폼 설계를 제안한다. 특히, 이 QbD 플렛폼을 통해 대조약과 시험약 간의 생물학적 동등성 의약품 제조에 필요한 실험설계방법을 획기적으로 개선하고자 한다. 이를 위해 본 논문은 먼저 QbD의 단계 중 실험설계법을 제형연구의 예를 들어 설명하고 본 논문이 계획한 QbD 플랫폼의 구조를 제안한다.

• 품질경영학회지
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• 제47권3호
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• pp.523-535
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• 2019

Purpose: We research on the efficient response surface methodology(RSM) design to develop a design space in Quality by Design(QbD). We propose practical designs for the successful construction of the design space in QbD by allowing different number of replicates at the box points, star points, and the center point in the rotatable central composite design(CCD). Methods: The fraction of design space(FDS) plot is used to compare designs efficiency. The FDS plot shows the fraction of the design space over which the relative standard error of predicted mean response lies below a given value. We search for practical designs whose minimal half-width of the tolerance interval per a standard deviation is less than 4.5 at 0.8 fraction of the design space. Results: The practical designs for the number of factors between two and five are listed. One of the designs in the list could be chosen depending on the experimental budget restriction. Conclusion: The designs with box points replications are more efficient than those with the star points replication. The sequential method to establish a design space is illustrated with the simulated data based on the two examples in RSM.

• 품질경영학회지
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• 제48권2호
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• pp.269-282
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• 2020

Purpose: The practical design for experiments with mixtures of q components is consisted in the four types of design points, vertex, center of edge, axial, and center points in a (q-1)-dimensional simplex space. We propose a sequential method for the successful construction of the design space in Quality by Design (QbD) by allowing the different number of replicates at the four types of design points in the practical design when the quadratic canonical polynomial model is assumed. Methods: To compare the mixture designs efficiency, fraction of design space (FDS) plot is used. We search for the practical mixture designs whose the minimal half-width of the tolerance interval per a standard deviation, which is denoted as d₂, is less than 4.5 at 0.8 fraction of the design space. They are found by adding the different number of replicates at the four types of the design points in the practical design. Results: The practical efficient mixture designs for the number of components between three and five are listed. The sequential method to establish a design space is illustrated with the two examples based on the simulated data. Conclusion: The designs with the center of edge points replications are more efficient than those with the vertex points replication. We propose the sample size of at least 23 for three components, 28 for four components, and 33 for the five components based on the list of efficient mixture designs.