• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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• pp.28-28
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• 2003

After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)

• International Journal of Stem Cells
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• 제17권2호
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• pp.113-119
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• 2024

This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss-threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.

• 품질경영학회지
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• 제20권2호
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• pp.94-108
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• 1992

This study involves an experiment for the cognitive experiment design and the human reliability in software engineering. Its overall objectives are to analyze common-cause human domain error and reliability in human-software interaction. A laboratory study was performed to analyze software engineers' task behavior in software production and to identify software design factors contributing to the effects in common cause failure redundancy. Common-cause model and its function were developed, then the main experiment using programming experts was conducted in order to define a new cognitive paradigm, in the aspects of identification, pattern recognition, and behavior domain for human reliability and quality control in software development. The results and analytical procedures developed in this research can be applied to reliability improvement and cost reduction in software development for many applications. Results are also expected to provide guidelines for software engineering quality control and for more effective design of human-software interface system.

• International Journal of Stem Cells
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• 제17권2호
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• pp.130-140
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• 2024

Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

• 한국식품조리과학회지
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• 제19권5호
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• pp.631-639
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• 2003

In order to control the quality and safety of cooked foods, production and holding methods of foods should be carefully studied and applied to the foodservice industry. Therefore studies on microbiological, nutritional, physicochemical and sensory quality are essential in this area. The purpose of this study was to evaluate the chemical and microbial qualities of cooked foods during preparation and holding From the results, the following guidelines should be adhered to give effective quality control when holding foods after cooking in foodservice institutions, as well as to provide quality foods when selling cooked foods at commercial establishments. Sauteed and simmered foods such as sauteed chicken meat & vegetables and simmered pork in soy sauce satisfy the standard for microorganisms till 1-3 hours of room temp. holding, 6-18 hours at 60$^{\circ}C$ steam table, and 12-18 hours at 80$^{\circ}C$ heating table.

• 한국물환경학회지
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• 제35권6호
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• pp.470-480
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• 2019

The Doam lake watershed was designated as a non-point pollution management area in 2007 to improve water quality based on watershed management implementation. There have been studies of non-point source reduction with respect to the watershed management impacting the pollutant transport of the reservoir. However, a little attention has been focused on the impact of water quality improvement by the management of the dam operation or the guidelines on the dam operation. In this study, the impact of in-lake management practices combined with watershed management is analyzed, and the appropriate guidelines on the operation of the dam are suggested. The integrated modeling system by coupling with the watershed model (HSPF) and reservoir water quality model (CE-QUAL-W2) was applied for analyzing the impact of water quality management practices. A scenario implemented with sedimentation basin and suspended matter barrier showed decrease in SS concentration up to 4.6%. The SS concentration increased in the scenarios adjusting withdrawal location from EL.673 m to the upper direction(EL.683 m and EL.688 m). The water quality was comparably high when the scenario implemented all in-lake practices with water intake at EL.673 m. However, there was improvement in water quality when the height of the water intake was moved to EL.688 m during the summer by preventing sediments inflow after the rainfall. Therefore, to manage water quality of the Doam lake, it is essential to control the water quality by modulating the height of water intake through consistent turbidity monitoring during rainfall.

• 의료ㆍ복지 건축 : 한국의료복지건축학회 논문집
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• 제22권3호
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• pp.7-15
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• 2016

Purpose: As medicare services have gotten spreaded, clinical laboratory has been dominant position. So, it has been acted for quality control and clinical pathology accreditation. But there has been quite deficient information to evaluate working space and technical standards of medical laboratory for accreditation. This study goals to figure out accreditation standard and design guideline for clinical laboratory, and to give safe and efficient design information. Methods: This study has been searched by literature for accreditation standards and design guidelines of clinical pathology in USA, UK, and Germany. Results: Three countries have accredited based on working lab space, staff space, storage space, patient space and health and safety equipment. Design guidelines of three countries commonly have focused on worktable layout, worktable distance and module, and specific laboratory biosafety level. And USA guidelines stress on the architectural design such as design process and passage distance for escape, UK stress on the efficiency as functional work flow and construction cost, lastly Germany design guidelines stress on the operator's safety distance and workstation. Three countries have not only accreditation standards but also design guidelines for more specific quality management, separating from accrediting institute. Implications: In korea, it has been needed to make clinical laboratory design guideline for the safe and efficient environment and reliable and competitive medical service.

• 한국의학물리학회지:의학물리
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• 제29권4호
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• pp.123-136
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• 2018

The complex dose distribution and dose transfer characteristics of intensity-modulated radiotherapy increase the importance of precise beam data measurement and review in the acceptance inspection and preparation stages. In this study, we propose a process map for the introduction and installation of high-precision radiotherapy devices and present items and guidelines for risk management at the acceptance test procedure (ATP) and commissioning stages. Based on the ATP of the Varian and Elekta linear accelerators, the ATP items were checked step by step and compared with the quality assurance (QA) test items of the AAPM TG-142 described for the medical accelerator QA. Based on the commissioning procedure, dose quality control protocol, and mechanical quality control protocol presented at international conferences, step-by-step check items and commissioning guidelines were derived. The risk management items at each stage were (1) 21 ionization chamber performance test items and 9 electrometer, cable, and connector inspection items related to the dosimetry system; (2) 34 mechanical and dose-checking items during ATP, 22 multileaf collimator (MLC) items, and 36 imaging system items; and (3) 28 items in the measurement preparation stage and 32 items in the measurement stage after commissioning. Because the items presented in these guidelines are limited in terms of special treatment, items and practitioners can be modified to reflect the clinical needs of the institution. During the system installation, it is recommended that at least two clinically qualified medical physicists (CQMP) perform a double check in compliance with the two-person rule. We expect that this result will be useful as a radiation safety management tool that can prevent radiation accidents at each stage during the introduction of radiotherapy and the system installation process.

• 한국식생활문화학회지
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• 제11권2호
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• pp.235-242
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• 1996

Sanitary management practices from 8 packaged meals (Dosirak) manufacturing establishments were surveyd during production and distribution and their microbiological quality of dosirak items marketed in CVS were analyzed. Correlation coefficients were calculated to deternine significant relationships between sanitary management practices and microbiological quality of packaged meals. The results of self evaluation on sanitary management practices indicated 'doing practice well' in personnel and equipment sanitation management but time-temperature control management were practiced satisfactorily only about 55% as compared with the managerial standard guidelines. Significant relationships between the status of actual sanitary management practices and microbiological quality of Dosirak items were not found, but general status of microbiological quality of Dosirak items revealed positive relationship with the size of operational structure and the status of time-temperature control management practices.

• 정보교육학회논문지
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• 제11권4호
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• pp.483-495
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• 2007

교육용 콘텐츠의 질 관리 방안을 정립하기 위해 본 논문은 교육용 콘텐츠의 질 관리 대상이 되는 콘텐츠 범위를 수립하고 소프트웨어의 생명주기와 기존의 콘텐츠 생명주기를 분석한 후, 현재 상황에 적합한 생명주기를 정의하고 단계 별 질 관리 절차를 제시하여 콘텐츠의 개발과 활용을 지원하도록 하였다. 교육용 콘텐츠가 생성되고 소멸하기까지의 모든 과정을 생명주기로 정의하였으며 개발과정은 기획, 설계, 제작단계로 구분하고, 활용과정은 평가, 유통, 관리단계로 구분하여 질 관리 지침을 수립하고 제공하여 콘텐츠를 개발하는 개발자와 개발의 진행을 지원하는 관리자 모두에게 적용할 수 있는 모델을 개발 하였다.