• 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 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.

• Journal of the Korean Society of Radiology
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• v.7 no.6
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• pp.397-402
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• 2013

This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.

• Journal of Korean Society for Quality Management
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• v.50 no.4
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• pp.717-734
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• 2022

Purpose: The purpose of this study is to effectively detect violations that occur simultaneously against Good Manufacturing Practice, which were concealed by drug manufacturers. Methods: In this study, we present an analysis framework for analyzing regulatory violation patterns using Association Rule Mining (ARM), Text Mining, and t-distributed Stochastic Neighbor Embedding (t-SNE) to increase the effectiveness of on-site inspection. Results: A number of simultaneous violation patterns was discovered by applying Association Rule Mining to FDA's inspection data collected from October 2008 to February 2022. Among them there were 'concurrent violation patterns' derived from similar regulatory ranges of two or more regulations. These patterns do not help to predict violations that simultaneously appear but belong to different regulations. Those unnecessary patterns were excluded by applying t-SNE based on text-mining. Conclusion: Our proposed approach enables the recognition of simultaneous violation patterns during the on-site inspection. It is expected to decrease the detection time by increasing the likelihood of finding intentionally concealed violations.

• International Journal of Quality Innovation
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• v.7 no.1
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• pp.35-47
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• 2006

Client-supplier collaboration has been an imperative approach to new product development (NPD), in which a good product specification management system and practice is crucial to the assurance of product quality. This study investigates product specification management in client-supplier collaborative NPD. Based on the interviews and survey study, 12 problems and 13 good practices of product specification management are identified. It also compares the importance and degree of the implementation of the product specification practices in Hong Kong electronics industry. The results suggest that more intensive practices should be implemented for better product specification management.

• 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.

• The Journal of Asian Finance, Economics and Business
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• v.7 no.11
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• pp.1041-1047
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• 2020

The intention of this paper is to give a better understanding about the implementation of sustainable manufacturing practice in the textile companies in Indonesia as one of the promising sectors in the manufacturing industry. The data was collected by taking a case study approach in one of the leading textile companies in Indonesia. Questionnaire and interview techniques were used to gather in-depth information about the implementation of a sustainable concept in the company. The result reveals that the extent of the implementation of Sustainable Manufacturing Practices (SMP) in the companies are at a level of moderate to high. From the three dimensions measured which are environment, economy, and social dimensions, the evaluation result shows good performance in terms of the implementation of sustainable concepts, like low level of gas emission, high percentage of renewable energy usage, cost reduction rate, high quality of life, etc. From this result, the authors then develop a sustainable manufacturing model in the wider coverage to be implemented not only in the textile industry but is expected to be implemented in manufacturing sectors as well. This model consists of at least seven basic archetypes which are divided into three dominant areas: technological innovation, economical, and social areas which aim to bring better performance in the manufacturing industry of Indonesia.

• 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.

• 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).

• IE interfaces
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• v.22 no.1
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• pp.85-94
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• 2009

Nowadays, most of the major manufacturing companies prepare their manufacturing schedule using package based solutions. Even though the accuracy of the detail scheduling result is high at implementation, however, it is low during maintenance period. The main cause of low accuracy during maintenance period is due to difficulties in maintaining the accurate level of master data. In this paper, we propose to easily maintain setup time, which is one of the most important factors required in master data to achieve good scheduling result, after changing job. This paper is mainly focused on how to deduce the factors that influence the setup time in a roll-based manufacturing field with print operations. For this purpose, we employed rule based algorithm and applied for deciding setup time for the existing product items. Likewise, it can be applied to new items without any complex setup procedures, and, finally, it displays the result of the real setup-time and calculated setup-time.