• Journal of Radiopharmaceuticals and Molecular Probes
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• v.1 no.2
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• pp.98-103
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• 2015

Good manufacturing Practice (GMP) regulation for diagnostic and therapeutic radiopharmaceuticals was prepared at 2014. The mandatory GMP regulation becomes effective on $1^{st}$, July 2015,with two years of grace periods. Korean radiopharmaceuticals GMP regulation was consisted of quality management, personnel, premise and facility, documentation, production, quality control and self-audit and they have a very similar structure to European Union and PIC/S GMP regulation. Here, we describe detailed description of GMP regulation each part and application to radiopharmaceuticals production. And we also compare Korea, Japan and USA radiopharmaceuticals GMP regulation. GMP is a method to maintain quality of radiopharmaceuticals in daily production and it must be embedded on the manufacturing operation and management.

• YAKHAK HOEJI
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• v.59 no.1
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• pp.40-46
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• 2015

The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

• Journal of Evidence-Based Herbal Medicine
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• v.3 no.1
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• pp.19-23
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• 2010

Gyeongsangbukdo is nation's leading producer of medicinal crop. Based on this, Gyeongbuk-specific measures for the development of oriental medicine industry is proposed. The aim is the development of oriental medicine industry and regional economic in Gyeongbuk. Production, research and development, manufacturing, distribution are constructed in industrial cluster. And each step need a quality control strictly. In production field, make the seed valley of medicinal crop and Good Agricultural Practice park. In research and development field, study on efficacy of oriental medicine with Good Laboratory Practice. In manufacturing field, make industrial park for foods, dietary supplements and drugs with Good Manufacturing Practice. In distribution field, supports advanced distribution program with Good Supply Practice.

• Journal of Korean Society for Quality Management
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• v.46 no.2
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• Journal of The Korea Institute of Healthcare Architecture
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• v.13 no.1
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• pp.7-15
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• 2007

The medicine is used for diagnosis, treatment or prevention of disease and consequently has an important influence upon human life and health. Its effectiveness and safety must be guaranteed. In order to achieve the facility that meets GMP, KFDA has provided standards for quality assurance of the manufacture, examination and tests of medical supplies. The result of this study were as follows : the GMP facilities are divided into work, lab/test and storage spaces, and the systematic corridor. The clean rooms are mainly installed in work and lab/test spaces, and maintain class 10,000 in average. The individual space for the procedures that requires class 100 is not provided as a separate division. Instead, they are performed in the clean bench of the laboratory.

• Toxicological Research
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• v.25 no.1
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• pp.1-8
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• 2009

Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

• The Korea Journal of Herbology
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• v.38 no.6
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• pp.61-71
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• 2023

Objectives : This study aimed to find out the future direction of accreditation system of Extramural herbal dispensaries (EHD) by comparing the current criteria of EHD and the existing Korea good manufacturing practice (GMP) regulations. Methods : Among the accreditation criteria of EHD, criteria of general herbal medicine was compared with the pharmaceutical GMP of Korea. The regulations of the accreditation of EHD and the regulations of KGMP were compared and organized with similar things based on the index of KGMP. All criteria from both were extracted for each element, classified into key-words and evaluated by dividing them into the same, similar one and no-matching. Results : Among the 189 criteria of KGMP, 77 criteria were consistent with the accreditation of EHD, and 15 criteria were similar. Based on the accreditation of EHD, 70.4% of the criteria were consistent or similar to KGMP. There were a total of 27 key-words only in the GMP criteria and not in the EHD one. Hence, a total of 25 key-words only in the EHD criteria and not in the GMP one. There were 12 similar key-words, and among them, there were 4 key-words in which accreditation of EHD was more specific than the KGMP. Conclusions : The criteria of general herbal medicine in EHD showed a similar or equivalent level of accreditation criteria compared to that of pharmaceutical GMP in Korea, and it ts believed that it should be considered at the current level to reflect the characteristics of herbal medicine.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.503-515
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• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• Proceedings of the Korean Institute Of Construction Engineering and Management
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• autumn
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• pp.494-497
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• 2002

The purpose of this study is to establish a prototype system for effective construction safety management. The research method involves comparison and adaptation into construction of quality and environment management systems in foreign and domestic manufacturing fields. The results of this study we as follows: The suggested model for construction safety management can be used effectively for the parties such as employer, employees, stakeholders, and the public especially through the application of performance measuring and reporting system.

• Journal of Pharmacopuncture
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• v.24 no.2
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• pp.59-67
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• 2021

Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.