• Title/Summary/Keyword: 의약품 안전 관리

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수입식품의 신고 및 검사 절차

  • 임기섭
    • Food Industry
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    • s.142
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    • pp.7-33
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    • 1997
  • 식품 등의 수입이 본격화되면서 수입식품에 관한 관리 및 통상관련업무를 전담할 조직(식품유통과, 현재 식품진흥과)이 보건복지부에 설치되고, 각 검역소에서 수입검사업무가 본격화된 것이 7년여에 이른다. 얼마되지 않는 기간이지만 그동안 국제적으로는 무역에 관한 환경의 변화, 국내적으로는 수입검사제도의 변화 등 이 분야에 많은 변화가 거듭되어 왔다. WTO체제의 출범이후 세계의 시장은 하나가 되어가고 이에 따라 각종 관련제도도 점차 조화를 이루어 가고 있으며, 지금도 각 나라는 양자간 또는 다자간 협상을 통하여 서로의 입장차를 좁혀 나가기 위한 노력이 계속되고 있는 것이 현실이다. 이러한 시점에서 각 나라는 보다 안전한 식품을 자국민에게 공급하기 위한 노력이 계속되고 있고, 우리나라도 작년 4월 식품의약품안전본부(KFDA)와 6개의 지방청이 발족되면서, 식품$\cdot$의약품 등의 안전관리를 전담하여 왔으며, 앞으로 독립외청으로 개편될 전망에 있다. 특히 내년부터는 수입식품관리업무가 완전한 전산화체제로 가동될 전망에 있어, 수입식품이 더욱더 효율적이고도 완벽한 관리가 될 것으로 기대된다. 이제 수입식품 등을 관리하는 업무가 무엇보다도 중요한 국가사무중의 하나가 되었고, 국민들의 관심과 기대 또한 높아지고 있다. 수입자가 식품 등을 수입하기 위하여 관련기관에 신고하기에서부터 검사기관에서는 이를 검사하고 수입신고필증을 발급하기 까지의 제반의 절차가 사실 식품위생법, 고시, 훈령 등에 의존하고 있는데, 이들이 여기저기 분산되어 있어 필요할 때마다 따로 따로 찾아보아야 하는 번거로움과 이해하는데에 어려움이 있어 온것이 사실이며, 오늘도 많은 담당공무원들이 민원인들의 방문 및 문의전화에 시달려야 한다. 사실 처음수입을 해본 사람이면 알 수 있을터이지만 알아야 할 사항이 한두가지가 아닌 것을 느낄 수 있을 것이다. 이러한 취지에서 수입업무를 담당하는 관련기관이나 업체에서 식품수입업무를 행하는데 있어서 조금이나마 보탬이 되었으면 하는 마음으로 집필하였다.

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Development and Validation of an Analytical Method for Quinoxyfen in Agricultural Products using QuEChERS and LC-MS/MS (QuEChERS법 및 LC-MS/MS를 이용한 농산물 중 살균제 Quinoxyfen의 잔류시험법 개발 및 검증)

  • Cho, Sung Min;Do, Jung-Ah;Lee, Han Sol;Park, Ji-Su;Shin, Hye-Sun;Jang, Dong Eun;Choi, Young-Nae;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.2
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    • pp.140-147
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    • 2019
  • An analytical method was developed for the determination of quinoxyfen in agricultural products using the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The samples were extracted with 1% acetic acid in acetonitrile and water was removed by liquid-liquid partitioning with $MgSO_4$ (anhydrous magnesium sulfate) and sodium acetate. Dispersive solid-phase extraction (d-SPE) cleanup was carried out using $MgSO_4$, PSA (primary secondary amine), $C_{18}$ (octadecyl) and GCB (graphitized carbon black). The analytes were quantified and confirmed by using LC-MS/MS in positive mode with MRM (multiple reaction monitoring). The matrix-matched calibration curves were constructed using six levels ($0.001-0.25{\mu}g/mL$) and the coefficient of determination ($R^2$) was above 0.99. Recovery results at three concentrations (LOQ, 10 LOQ, and 50 LOQ, n=5) were in the range of 73.5-86.7% with RSDs (relative standard deviations) of less than 8.9%. For inter-laboratory validation, the average recovery was 77.2-95.4% and the CV (coefficient of variation) was below 14.5%. All results were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and Food Safety Evaluation Department guidelines (2016). The proposed analytical method was accurate, effective and sensitive for quinoxyfen determination in agricultural commodities. This study could be useful for the safe management of quinoxyfen residues in agricultural products.

Development and Validation of an Analytical Method for Fenpropimorph in Agricultural Products Using QuEChERS and LC-MS/MS (QuEChERS법과 LC-MS/MS를 이용한 농산물 중 Fenpropimorph 시험법 개발 및 검증)

  • Lee, Han Sol;Do, Jung-Ah;Park, Ji-Su;Cho, Sung Min;Shin, Hye-Sun;Jang, Dong Eun;Choi, Young-Nae;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.2
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    • pp.115-123
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    • 2019
  • An analytical method was developed for the determination of fenpropimorph, a morpholine fungicide, in hulled rice, potato, soybean, mandarin and green pepper using QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) sample preparation and LC-MS/MS (liquid chromatography-tandem mass spectrometry). The QuEChERS extraction was performed with acetonitrile followed by addition of anhydrous magnesium sulfate and sodium chloride. After centrifugation, d-SPE (dispersive solid phase extraction) cleanup was conducted using anhydrous magnesium sulfate, primary secondary amine sorbents and graphitized carbon black. The matrix-matched calibration curves were constructed using seven concentration levels, from 0.0025 to 0.25 mg/kg, and their correlation coefficient ($R^2$) of five agricultural products were higher than 0.9899. The limits of detection (LOD) and quantification (LOQ) were 0.001 and 0.0025 mg/kg, respectively, and the limits of quantification for the analytical method were 0.01 mg/kg. Average recoveries spiked at three levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n=5) and were in the range of 90.9~110.5% with associated relative standard deviation values less than 5.7%. As a result of the inter-laboratory validation, the average recoveries between the two laboratories were 88.6~101.4% and the coefficient of variation was also below 15%. All optimized results were satisfied the criteria ranges requested in the Codex guidelines and Food Safety Evaluation Department guidelines. This study could serve as a reference for safety management relative to fenpropimorph residues in imported and domestic agricultural products.

Safety Leader - 대한적십자사 혈장분획센터 신창우 원장

  • Yeon, Seul-Gi
    • The Safety technology
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    • no.203
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    • pp.16-17
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    • 2014
  • 대한적십자사 혈장분획센터는 국민들의 헌혈을 통해 수집된 혈장으로 부터 단백질을 분획해 알부민, 면역글로불린 등의 원료가 되는 혈장분획제제를 생산 공급하는 전담 기관이다. 이들 의약품이 혈우병, 간경변증, 무감마그로불린혈증, 가와사키병 등 각종 질병의 치료에 쓰인다는 점을 감안하면, 사실상 이곳은 국민생명보호의 최일선 현장이라고 할 수 있다. 때문에 이곳은 그동안 '국민건강의 핵심시설' 또는 '국가보건인프라의 중추' 등으로 불려왔다. 이처럼 의료 및 보건분야의 중요시설로 알려진 이곳이 최근 특이하게도 '전국 최고의 안전사업장'으로 유명세를 치르고 있다. 깐깐하기로 유명한 위험성평가 우수사업장 인정 심사를 만점에 가까운 접수로 통과한 것이 그 배경이다. 이곳이 이처럼 안전명가의 반열에 올라설 수 있었던 비결은 무엇일까. 이에 대한 해답은 현재 센터를 이끌고 있는 신창우 원장에게서 찾을 수 있다. 그는 안전보건과 관련된 일이라면 무엇이든 앞장서고, 실무자들에 대해 전폭적인 지원을 아끼지 않고 있다. 국민의 소중하고 고귀한 혈액을 기반으로 의약품을 만드는 곳이기에, 단 한 방울의 혈액도 낭비되는 일이 없도록 철저한 안전관리를 펼쳐야 한다고 말하는 그를 만났다.

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Changes in the Behavior of Healthcare Organizations Following the Introduction of Drug Utilization Review Evaluation Indicators in the Healthcare Quality Evaluation Grant Initiative (의료질평가지원금 제도의 의약품안전사용서비스 평가지표 도입에 따른 의료기관의 행태 변화)

  • Hyeon-Jeong Kim;Ki-Bong Yoo;Young-Joo Won;Han-Sol Jang;Kwang-Soo Lee
    • Health Policy and Management
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    • v.34 no.2
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    • pp.178-184
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    • 2024
  • Background: This study aimed to determine the effectiveness of drug utilization review (DUR) evaluation indicators on safe drug use by comparing the changes in DUR inspection rates and drug duplication prescription prevention rates between the pre- and post-implementation of the DUR evaluation indicators of the Healthcare Quality Evaluation Grant Initiative. Methods: This study used DUR data from the Health Insurance Review and Assessment Service in 2018 (pre-implementation) and the evaluation results of the Healthcare Quality Evaluation Grant Initiative in 2023 (post-implementation). The dependent variables were the DUR evaluation indicators, including DUR inspection rate and drug duplicate prescription prevention rate. The independent variable was the implementation of the DUR evaluation indicators, and the control variables included medical institution characteristics such as type, establishment classification, location, DUR billing software company, and number of beds. Results: The results of the analysis of the difference in the prevention rate of drug duplicate prescriptions between the pre- and post-implementation of the DUR evaluation indicators of the Healthcare Quality Evaluation Grant Initiative showed that the prevention rate of drug duplicate prescriptions increased statistically significantly after the implementation of the DUR evaluation indicators. Conclusion: The policy implications of this study are as follows: First, ongoing evaluation of DUR systems is needed. Second, it is necessary to establish a collaborative partnership between healthcare organizations that utilize DUR system information and the organizations that manage it.

Development of a Simultaneous Analytical Method for Determination of Herbicide Fenquinotrione and KIH-3653-M-2 Residues in Agricultural Crops using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 제초제 fenquinotrione 및 대사산물 KIH-3653-M-2 동시시험법 개발)

  • Park, Ji-Su;Do, Jung-Ah;Lee, Han Sol;Cho, Sung Min;Shin, Hye-Sun;Jang, Dong Eun;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.3
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    • pp.242-250
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    • 2019
  • An analytical method was developed for the determination of fenquinotrione, a triketone herbicide, in agricultural products. Fenquinotrione was metabolized to KIH-3653-M-2 in plants. Analyte extraction was conducted using 2% formic acid in acetonitrile and cleaned up using a hydrophillic-lipophillic balance (HLB) cartridge. The limits of detection (LOD) and quantification (LOQ) were 0.004 and 0.01 mg/kg, respectively. Matrix-matched calibration curves were linear over the calibration ranges ($0.001{\sim}0.1{\mu}g/mL$) into a blank extract with $r^2>0.99$. The recovery results for fenquinotrione and KIH-3653-M-2 ranged between 81.1 to 116.2% and 78.0 to 110.0% at different concentration levels (LOQ, $10{\times}LOQ$, $50{\times}LOQ$) with relative standard deviation (RSD) less than 4.6%. All values were corresponded with the criteria ranges requested in both the Codex (CAC/GL 40-1993, 2003) and MFDS guidelines (2016). Therefore, the proposed method can be used as an official analytical method for determination of fenquinotrione in the Republic of Korea.

Analysis of Korean Dietary Patterns using Food Intake Data - Focusing on Kimchi and Alcoholic Beverages (식품섭취량을 활용한 우리나라 식이 패턴 분석 - 김치류 및 주류 중심으로)

  • Kim, Soo-Hwaun;Choi, Jang-Duck;Kim, Sheen-Hee;Lee, Joon-Goo;Kwon, Yu-Jihn;Shin, Choonshik;Shin, Min-Su;Chun, So-Young;Kang, Gil-Jin
    • Journal of Food Hygiene and Safety
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    • v.34 no.3
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    • pp.251-262
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    • 2019
  • In this study, we analyzed Korean dietary habits with food intake data from the Korea National Health and Nutrition Examination Survey (KNHANES) and the Korea Centers for Disease Control and Prevention and we proposed a set of management guidelines for future Korean dietary habits. A total of 839 food items (1,419 foods) were analyzed according to the food catagories in "Food Code", which is the representative food classification system in Korea. The average total daily food intake was 1,585.77 g/day, with raw and processed foods accounting for 858.96 g/day and 726.81 g/day, respectively. Cereal grains contributed to the highest proportion of the food intake. Over 90% of subjects consumed cereal grains (99.09%) and root and tuber vegetables (95.80%) among the top 15 consumed food groups. According to the analysis by item, rice, Korean cabbage kimchi, apple, radish, egg, chili pepper, onion, wheat, soybean curds, potato, cucumber and pork were major (at least 1% of the average daily intake, 158.6 g/day) and frequently (eaten by more than 25% of subjects, 5,168 persons) consumed food items, and Korean spices were at the top of this list. In the case of kimchi, the proportion of intake of Korean cabbage kimchi (64.89 g/day) was the highest. In the case of alcoholic beverages, intake was highest by order of beer (63.53 g/day), soju (39.11 g/day) and makgeolli (19.70 g/day), and intake frequency was high in order of soju (11.3%), beer (7.2%), and sake (6.6%). Analysis results by seasonal intake trends showed that cereal grains have steadily decreased and beverages have slightly risen. In the case of alcoholic beverage consumption frequency, some kinds of makgeolli, wine, sake, and black raspberry wine have decreased gradually year by year. The consumption trend for kimchi has been gradually decreasing as well.

The Meaning and the Legislative Suggestion about Data Manipulation of Pharmaceutical Companies in the Aspect of the Medicine Approval System (의약품 품목허가 제도에서 제약기업 자료조작의 의미와 입법 개선 방안-대법원 2008. 11. 13. 선고 2008두8628 판결을 중심으로-)

  • Park, Sungmin;Shin, Youngkee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.59-88
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    • 2021
  • The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.

Study on Mobile Container Management for Smart Cold Chain (Smart Cold Chain을 위한 이동 컨테이너 관리 기법 연구)

  • Park, Jin-Hee;Kim, Young-Chan
    • Proceedings of the Korean Information Science Society Conference
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    • 2010.06d
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    • pp.393-396
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    • 2010
  • 웰빙문화의 확산으로 안전한 식자재에 대한 소비자의 욕구가 대두되면서 온도와 습도 등의 환경 인자에 민감한 식자재, 의약품, 혈액 등의 물류 유통 상의 신선하고 안전한 환경을 제공할 수 있도록 냉동/냉장 이동 컨테이너 안의 온도와 습도 등의 환경 상태 등을 관리하기 위한 센서 네트워크를 적용한 냉동/냉장 컨테이너의 관리 기법을 연구한다.

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Exposure Assessment of Heavy Metals Migrated from Glassware on the Korean Market (국내 유통 식품용 유리제의 중금속 노출 평가)

  • Kim, Eunbee;Hwang, Joung Boon;Lee, Jung Eun;Choi, Jae Chun;Park, Se-Jong;Lee, Jong Kwon
    • KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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    • v.28 no.1
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    • pp.15-21
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    • 2022
  • The purpose of our study was to investigate the migration level of lead (Pb), cadmium (Cd), and barium (Ba) from glassware into a food simulant and to evaluate the exposure of each element. The test articles were glassware, including tableware, pots, and other containers. Pb, Cd, and Ba were analysed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). The analytical performance of the method was validated in terms of its linearity, limit of detection (LOD), limit of quantification (LOQ), recovery, precision, and uncertainty. The monitoring was performed for 110 samples such as glass cups, containers, pots, and bottles. a food simulant. Migration test was conducted at 25? for 24 hours in a dark place using 4% acetic acid as a food simulant. Based on the data; exposure assessment was carried out to compare the estimated daily intake (EDI) to the human safety criteria. The risk levels of Pb and Ba determined in this study were approximately 1.9% and 0.3% of the provisional tolerable weekly intake (PTWI) and tolerable daily intake (TDI) value, respectively, thereby indicating a low exposure to the population.