• 혜화의학회지
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• 제22권1호
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• pp.129-143
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• 2013

This study was conducted to investigate the residue amount of pesticide on the 41 medicinal herbs in Daejeon area. This study was carried out to monitor the current status of pesticide residues in commercial medicinal herbs for sale of food use in 2012. It was performed using GC/ECD, GC/NPD, HPLC to analyze pesticides residues. Residues of 283 pesticides were analyzed by a simultaneous multiresidue method in 41 medicinal herbs being on sale in Daejeon. The medicinal herbs detected pesticides in 10 of 41 cases, showed a detection rate of 24.39%. The medicinal herbs which exceed the maximum residue limit were five cases as Cnidii Rhizoma, Osterici Radix, Artemisiae Capillaris Herba, Zizyphi Fructus and Alismatis Rhizoma. And pesticide residue of Cnidii Rhizoma and Alismatis Rhizoma exceeds the limit standard presented in only medicine use of KFDA. The residual pesticides which had the high detection rate were Chlopyrifos, Tebuconazole and Endosulfan in the detection of medicinal herbs. For further research, standards of Pesticide Residues in medicinal herbs should be added and more research of pesticide residues in medicinal herbs required. And standards of pesticide residues in medicinal herbs should be applied equally as medicines and food.

• 의료ㆍ복지 건축 : 한국의료복지건축학회 논문집
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• 제13권1호
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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.

• 한국식품위생안전성학회지
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• 제23권1호
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• pp.19-25
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• 2008

본 연구는 검역원의 선행요건 항목을 식약청 및 미국 FSIS의 선행요건과 비교 검토함으로써, 보완되어야 할 검역원 선행요건의 내용과 범위를 제시하고자 하였다. 검역원과 식약청 모두 HACCP 고시에서 선행요건 평가항목을 제시하고 있으나 서로 상이한 부분이 많이 발견되므로 관리항목 범위와 내용을 조정할 필요성이 지적되었다. 또한 HACCP 적용업소가 지속적으로 확대되면 업종별 작업환경조건이 다양해지므로 HACCP 고시에서는 선행요건 관리항목의 기본 틀만 제시하고 세부지침 및 일치 불일치 조건은 별도로 명시하여 관리하는 것이 선행요건의 현장적용 활용성을 높이고 평가업무의 표준화를 이루는데 필수적인 것으로 파악되었다.

• Journal of Acupuncture Research
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• 제24권6호
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• pp.195-206
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• 2007

Objectives : The aim of this study is to investigate the safety of Acupuncture needles made from duplex stainless steel. Methods : In order to check the safety concern of the DSS Acupuncture needle, we employed biochemical measures, DSS and SS304 Acupuncture needles were tested for pH level, heavy metals and UV absorbance spectrum along with cytotoxicity and hemolysis. As a guideline, we have referred to the 'standards for acupuncture needles', 'standards for disposable needles' and 'standards and experimental procedures for stents' for the Korean Food & Drug Administration(KFDA). Results & Conclusions : The DSS Acupuncture needle extract satisfied these requirements. There was no significant difference between the DSS and SS304 Acupuncture needle extract. In conclusion, the DSS Acupuncture needle displayed biochemical safety.

• 대한수혈학회지
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• 제23권2호
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• pp.152-161
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• 2012

배경: 2012년 1월부터 국내에 신규로 도입되는 고위험군 바이러스 검사시약은 국내 검체를 이용한 성능 시험분석을 실시하여 식품의약품안전청 허가를 득하도록 일부 규정이 개정되었다. 이러한 바이러스 진단시약의 성능시험과 품질관리 규정을 이행하기 위해서는 국내 검체에서 유래된 국가표준물질이 필요하다. 이에 본 연구에서는 바이러스 핵산증폭검사시약의 성능평가와 품질관리를 위하여 다양한 농도로 구성된 HBV, HCV와 HIV의 핵산증폭검사용 혈장유래 표준물질(plasma working standards)을 제조하고자 하였다. 방법: 수혈 부적격의 HCV RNA 양성혈장 43단위, HCV RNA 양성혈장 25단위, 그리고 HIV RNA 양성혈장 26단위에 대해 핵산 정량검사와 유전자형 검사를 실시하였다. 이를 바탕으로 국내에서 유행하는 바이러스의 유전자형을 가진 고농도의 원료혈장을 선정하였다. 또 표준물질의 다양한 농도는 국내외 검사시약의 검출범위에 근거하여 적정한 농도범위를 선택한 후, 다양한 농도로 원료물질을 희석하고, 분병 처리 한 후 정량적으로 분석하였다. 결과: HBV, HCV와 HIV의 체외진단분석기용 핵산증폭검사의 성능평가용 plasma working standards는 총 13종의 다양한 농도물질로 제조되었다. 결론: 국내에서 혈액관련 고위험군 HBV, HCV와 HIV의 체외진단용 핵산증폭검사 시약의 성능 평가에 필요한 바이러스 핵산 검사용 국가표준물질을 처음 제조하여 그 기술을 수립하였다.

• 재활복지공학회논문지
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• 제3권1호
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• pp.41-47
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• 2009

본 논문에서는 중추신경계나 대뇌피질의 운동 및 감각기능을 검사하는 근전도계 및 유발성응답기의 안전 요구사항 및 시헙방법을 기술한다. 국제 기준에 부합화하는 안전 요구사항을 설정하고, 국제 표준에 따른 시험방법 및 표준 시험절차서를 제시하였다. 그러나 장비의 개별 성능 요구사항은 특정하지 않고, 제조사에서 제시하는 성능이나 출력이 가능하도록 규정하였다. 시중에 유통되고 있는 근전도계 장비를 이용하여 제시된 시험방법에 대한 유효성을 확인하였다. 이 연구의 결과는 식품의약품안전청에서 의료기기 인허가시 적용되는 기준규격으로서 사용될 수 있을 것이다.

• Bulletin of the Korean Chemical Society
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• 제28권3호
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• pp.369-372
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• 2007

A fast and simple high-performance liquid chromatography (HPLC) method for the simultaneous determination of four pesticides having fungicide properties has been proposed for Panax ginseng, C. A. Meyer grown for 4, 5, or 6 years. Analytical separation was performed on C18 columns using ultraviolet detector under gradient conditions. Spiked blank samples were used as standards to counteract the matrix effect observed in the chromatographic determination. The HPLC response for all pesticides was linear, with determination coefficients > 0.9986. The average rate of recovery for pesticides spiked with 2 fortification levels was > 72% with relative standard deviations < 9%. The limits of quantification (LOQ) ranged from 0.03 to 0.16 ppm. These LOQs were lower than the respective maximum residue limits (MRL) established by the Korean Food and Drug Administration (KFDA), except for cyazofamid. The proposed method was used to determine pesticide residue levels in samples of ginseng obtained from Jeonnam Province (Republic of Korea). None of the pesticides were found in ginseng samples grown for 4, 5, or 6 years.

• 수산해양교육연구
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• 제28권3호
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• pp.713-726
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• 2016

This study were attempted to apply the HACCP system adopted in the dried anchovy workplace to ensure the hygiene safety of dried anchovy workplace. In this study, HACCP system procedures, including HACCP team organization, determination of critical control point(CCP), establishment of critical limits, mornitering and verification etc., were established using KFDA 12 procedures. To determine whether hazards were critical elements, we evaluated the likelihood and seriousness of each hazard element. The likelihood of residual microorganism and metal piece exceeding the acceptable limit in dried anchovy products were demonstrated to be a critical hazard element. Management of the boiling(CCP-1B) and metal detection(CCP-2P) were determined to be a critical control point. The standards for acceptable residual microorganism and metal piece were set based on relevant laws and regulations, and then the limits were adapted and established for the CCP. An HACCP plan applicable to dried anchovy workplace was established.

• 대한안전경영과학회지
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• 제12권3호
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• 약학회지
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• 제44권4호
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• pp.308-314
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• 2000

Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).