• 제목/요약/키워드: Good Manufacturing Practices

검색결과 21건 처리시간 0.022초

원외탕전실 평가인증기준과 KGMP 평가인증 기준과의 비교연구 (A Study on the Comparison of Korea Good Manufacturing Practice (KGMP) Evaluation Criteria with Certification Criteria of Extramural Herbal Dispensaries)

  • 김형기;황의형;이은경;임병묵;신영재;박선영;신병철
    • 대한본초학회지
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    • 제38권6호
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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.

Development of a Design System for Multi-Stage Gear Drives (2nd Report : Development of a Generalized New Design Algortitm

  • Chong, Tae-Hyong;Inho Bae
    • International Journal of Precision Engineering and Manufacturing
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    • 제2권2호
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    • pp.65-72
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    • 2001
  • The design of multi-stage gear drives is a time-consuming process, since on includes more complicated problems, which are not considered in the design of single-stage gear drives. The designer has th determine the number of reduction stages and the gear ratios of each reduction state. In addition, the design problems include not only the dimensional design but also the configuration design of gear drive elements. There is no definite rule and principle for these types of design problems. Thus the design practices largely depend on the sense and the experiences of the designer , and consequently result in undesirable design solution. We propose a new generalized design algorithm to support the designer at the preliminary design phase of multi-stage gear drives. The proposed design algorithm automates the design process by integrating the dimensional design and the configuration design process. The algorithm consists of four steps. In the first step, a designer determines the number of reduction stage. In the second step. gear ratios se chosen by using the random search method. In the third step, the values of basic design parameter are chosen by using the generate and test method. Then, the values of other dimension, such ad pitch diameter, outer diameter, and face width, are calculated for the configuration design in the final step. The strength and durability of a gear is guaranteed by the bending strength and the pitting resistance rating practices by using the AGMA rating formulas. In the final step, the configuration design is carried out b using the simulated annealing algorithm. The positions of gears and shafts are determined to minimize the geometrical volume(size) of a gearbox, while satisfying spatial constraints between them. These steps are carried out iteratively until a desirable solution is acquired. The propose design algorithm has been applied to the preliminary design of four-stage gear drives in order to validate the availability. The design solution have shown considerably good results in both aspects of the dimensional and the configuration design.

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주요 고농서를 통한 조선시대의 도작기술 전개 과정 연구 VIII. 수확 저장 요령 (A Study on Transition of Rice Culture Practices during Chosun Dynasty through Old References. VIII. Harvest and Storage)

  • 이숭겸;구자옥;이은웅;이홍석
    • 한국작물학회지
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    • 제37권3호
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    • pp.299-303
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    • 1992
  • 농업기술의 일반적인 농법들과 마찬가지로, 우리나라의 벼 수확법이나, 저장법 또는 조제법도 고대 중국의 기술과 방법을 받아 형성되어 온 것으로 보인다. 그러므로 벼 수확법의 최적시기는 손실을 막기 위해서 적절한 배수를 하므로써 정해진 수확과 조제를 위한 효율적인 농구가 사용되었으며 또한 벼 저장을 위한 특이하고 창조적인 기술이 교육됨으로서 쉽게 익혀졌다. 그것은, 풍우를 막고 좋은 통기조건을 갖게 했다. 15세기, 16세기에 저장보리의 곤충해를 막기위해 물여뀌 처리 그리고 벼낟알의 탈락을 막기위해 수확기 즉시에 벼베기를 하는 것이 장려되었다. 17세기는 창조적인 기술이 없었다. 18세기, 19세기에 포장에서 저장할 때의 쥐에 의한 해를 방제하기 위한 방법들이 제시되었다. 또한 여러 수도 품종들의 생태학과 장기간의 저장기술에 관한 연구들이 지역적으로 수확의 적시를 취하기 위하여, 또한 적시에 협동적으로 일하기 위하여 필순적으로 강조되었다.

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A Feasibility Study on the Lifelong Education Program of Holography Using Simple Hologram Making Tools

  • Park, Mi-Soo;Choi, Yoon-Hee;Ha, Sung-Jae;Gentet, Philippe;Lee, Jae-Hyun;Hwang, Lee-Hwan;Kwon, Soon-Chul;Lee, Seung-Hyun
    • International Journal of Internet, Broadcasting and Communication
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    • 제12권4호
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    • pp.128-136
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    • 2020
  • In this paper, we presented a simple hologram recording set for learners to broaden their program choices and experience holographic techniques with lifelong education programs. In order to obtain quality 3D images, the quality of light sources and recording mediums, which are the main elements of hologram recording, must be good. In addition, due to the characteristics of the hologram, the ambient vibrations shall be minimized for accurate interference pattern recording. The simple hologram recording set presented in this paper has not significantly restricted in space and location, and anyone can easily experience it at a reasonable price compared to the existing hologram production method. Also, it can make two different type of hologram (transmission and reflection) for providing easy access to recording and reconstruction of the hologram. Experiments have shown that holographic manufacturing practices are a very useful way to educate the public on optics and photonics technologies.

The Efficacy and Safety of Platelet-Rich Plasma and Adipose-Derived Stem Cells: An Update

  • Choi, Jaehoon;Minn, Kyung Won;Chang, Hak
    • Archives of Plastic Surgery
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    • 제39권6호
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    • pp.585-592
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    • 2012
  • During the past decade, many studies using platelet-rich plasma (PRP) or adipose-derived stem cells (ASCs) have been conducted in various medical fields, from cardiovascular research to applications for corneal diseases. Nonetheless, there are several limitations of practical applications of PRP and ASCs. Most reports of PRP are anecdotal and few include controls to determine the specific role of PRP. There is little consensus regarding PRP production and characterization. Some have reported the development of an antibody to bovine thrombin, which was the initiator of platelet activation. In the case of ASCs, good manufacturing practices are needed for the production of clinical-grade human stem cells, and in vitro expansion of ASCs requires approval of the Korea Food and Drug Administration, such that considerable expense and time are required. Additionally, some have reported that ASCs could have a potential risk of transformation to malignant cells. Therefore, the authors tried to investigate the latest research on the efficacy and safety of PRP and ASCs and report on the current state and regulation of these stem cell-based therapies.

Trends of Market and Approval Management System for in vitro Diagnostic Veterinary Medical Reagents in Korea

  • Kang, Kyoung-Mook;Kang, Min-Hee;Suh, Tae-Young;Kang, Hwan-Goo;Moon, Jin-San
    • 한국임상수의학회지
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    • 제35권4호
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    • pp.119-125
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    • 2018
  • In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

A study on digital transformation of SMEs from the perspective of information technology

  • PAN, Xiao-Yan
    • 4차산업연구
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    • 제2권1호
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    • pp.33-43
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    • 2022
  • Purpose - With the rapid development of information technology, the digital economy has become an important grip of the new development pattern, and the digital transformation of enterprises is a major trend. As SMEs are the mainstay of the economy and employment, it is important to study the digital transformation of SMEs to promote the development of the digital economy. Research design, data, and methodology - Based on a resource-based view, this report analyses the current situation and issues of digital transformation of SMEs from the perspective of digital orientation as well as the breadth and depth of technological capabilities of enterprises, using data from a survey of 200 manufacturing enterprises in China. Result - The results show that SMEs generally have a digital transformation mindset, but a weak digital foundation. In order to execute a digital strategy, companies need digital transformation capabilities. These behavioral capabilities are guided by the strategic direction of the business, and companies with strong capabilities are always trying to tap into the full digital potential. Conclusion - In order to effectively promote the digital transformation of SMEs, we suggest that SMEs pay attention to digital capability building, make good use of digital platforms and network resources, and lay a solid foundation for digital transformation; meanwhile, we suggest that government departments play a guiding and supporting role to build a cross-industry and cross-sector digital synergy system to help promote the development of SMEs' digital transformation. This paper presents some suggestions from both the internal and external environment of the enterprise, with the expectation of contributing to the digital transformation practices of SMEs.

WE CAN Cookies A Case Study in a Pioneering Social Enterprise in South Korea

  • Chang, Dae Ryun;Choi, Kyongon
    • Asia Marketing Journal
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    • 제14권4호
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    • pp.23-33
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    • 2013
  • This case focuses on WE CAN Cookies, a social enterprise in South Korea that was founded in 2001 with the support of the Korean Roman Catholic Church. WE CAN Cookies specializes in the making of high quality organic cookies. As a nonprofit organization that uses a labor force of mostly mentally disabled workers, the company faces many challenges that normal companies do not experience. The company had to initially overcome the social prejudice that the handicapped cannot make good cookies. Despite the religious background and social agenda of the company, it started making inroads as a cookie-making business only after its managers, including the nuns who run it began adopting modern management philosophies and practices. The WE CAN Cookies case illustrates three main marketing-related concepts: One, WE CAN Cookies is a good example of how social enterprises face a broader spectrum of challenges when compared to conventional profit-seeking enterprises. Two, WE CAN Cookies demonstrates that social enterprises need flexibility in formulating their business strategies. Even though WE CAN Cookies is subject to many constraints, as a social enterprise it can also take advantage of new opportunities for obtaining support from the government and from the private sector. Three, WE CAN Cookies shows that these types of operations need to create greater balance in their social and business competencies to ensure the long term viability. Social enterprises are certified by governments with the stated goal of improving the lives and the wellbeing of special interest group. As important as achieving these objectives are, social enterprises also must additionally be able to build their operational capabilities not only in manufacturing but also in functions such as marketing.

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국내 동물용 의료기기 관리실태 평가 및 개선방안 연구 (Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea)

  • 안효진;윤향진;김충현;위성환;문진산
    • 대한수의학회지
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    • 제55권2호
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    • pp.97-103
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    • 2015
  • In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

한방건강보험 약제 투약 실태 및 활성화 방안 연구 (A Study on the Current Status of Prescribed Drugs in Oriental Health Insurance and their Improvement)

  • 권용찬;유왕근;서부일
    • 대한본초학회지
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    • 제27권2호
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    • pp.1-16
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    • 2012
  • Objective : To investigate the current status of prescription drugs in Oriental medical institutes and to draw up a future plan for the revitalization of Oriental medical health insurance, this survey has been performed. Method : The survey has been made with 321 doctors working at Oriental medical institutes in Daegu and Kyungbuk areas for a period of 3 month from June 1, 2010 until September 1, 2010. Result : 1. When it comes to the current status of the use of herbal drugs in Oriental Health insurance, most of doctors surveyed prescribe insurance drugs, and they prescribe insurance drugs to patients, who are less than 20% of total patients visiting their clinics. 2. The awareness of Herbal Health Care Drugs is investigated. When it comes to the understanding of the difference between insurance drugs(powder type drugs) and granular type drugs, doctors admit that they differ only in one aspect, whether or not their being covered by health insurance. Based on the survey results on the understanding of insurance coverage of granular type drugs, doctors, even though they long for granular type drugs to be accepted as insurance drugs, are worrying whether the number of outpatients might dwindle due to increased insurance co-payments. They also point out that the biggest obstacles in the expansion of the granular type drugs as insurance drugs are the lack of understanding of the government and the objection of the Health Insurance Review and Assesment service (HIRA) for fear of increased insurance claims. 3. Upon investigation on Oriental medicine doctors' understandings of herbal pharmaceutical industry, it is found that doctors' responses on pharmaceutical industry are not all positive ones('new product development and neglect of R&D infrastructure' and 'smallness of industry'). When it is investigated what area needs the greatest improvement in herbal pharmaceutical industry, 'securing sufficient capital, good manufacturing, and strengthening quality control', is the highest. 4. When it is asked what are the most needed in order to improve herbal health insurance medicine, responses such as 'the increase in the accessibility to and the utilization of Oriental medical clinics through the diversification of the means of prescriptions', 'the improvement of insurance benefits(cap adjustments)', 'increase the proportion of high quality medicinal plants', 'the ceiling of co-payments(deductible) at 20,000 won or more', 'expansion of the choices of formulations', 'formulational expansions of tablets and pills', and finally 'admittance and expansion of granular type drug as insurance drug' are the highest. 5. Upon investigating the general characteristics of the current status of the usage of Oriental health care herbal drugs, the followings are observed. First, the frequency of use of health insurance drugs by the doctors who use health insurance with general characteristics shows similar differences in case of total monthly sales amount (p<0.001), average number of daily patients (p<0.05). Secondly, as to the willingness of the expanded usage of insurance drugs, similar differences are observed in case of total monthly sales amount (p<0.05). 6. Upon investigating the general characteristics of the perception of Herbal health care drugs, the followings are observed. First, inspecting general characteristics and insurance claims due to increased co-payments(deductible amount) reveals similar differences in case of working period (p<0.01) and in case of total monthly sales amount (p <0.01). Secondly, inspecting general characteristics and the obstacles that hinder granular type drugs from being accepted as health care insurance drugs shows similar differences in case of working period (p<0.05). 7. Upon investigating the general characteristics of the understanding of Oriental Herbal pharmaceutical companies, the followings are observed. First, opinions on the general characteristics of pharmaceutical companies, when examined with variance analysis, shows similar differences in case of total monthly sales amount (p<0.05). Secondly, when opinions are examined on general characteristics and the problems of herbal pharmaceutical companies, similar differences are found in case of working period (p<0.01) and in case of total monthly sales amount (p<0.001). Lastly, opinions on the general characteristics and reforms of pharmaceutical companies, similar differences are observed in case of working period (p<0.001). 8. Upon investigating the general characteristics of the improvement of insurance Herbal drugs, the followings are observed. First, regarding general characteristics and insurance benefits, similar differences are observed in case of working period (p<0.05), in case of total monthly sales amount (p<0.05), and in case of average number of daily patients (p<0.01). Secondly, opinions on the general characteristics and the needs for the improvement of Herbal insurance drugs are examined in 5 different aspects, which are the approval of granular type drugs as insurance drugs, the expanded practices of the number of prescription insurance drugs, the needs of a variety of formulations, the needs of TFT of which numbers of Oriental medical doctors are members for the revision of the existing system, and the needs of adjusting the current ceiling of the fixed amount and the fixed rate. When processed by the analysis of variance, the results show similar differences in case of average number of daily patients (p<0.01). Conclusion : From the results of this study the first measures to take are, to reform overall insurance benefit system, including insurance co-payment system(fixed rate cap adjustment), to expand the number of the herbal drugs to be prescribed matching with insurance benefit accordingly, and to revitalize herbal medicine insurance system through the change of various formulations. In addition, it is recommended to improve the effectiveness of herbal medicine by making plans to enhance the efficacy of herbal medicine and by enabling small pharmaceutical companies to outgrow themselves.