• Journal of Korea Society of Digital Industry and Information Management
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• v.17 no.4
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• pp.133-146
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• 2021

In the field of food and drug, the role of the Ministry of Food and Drug Safety is becoming more important for national and public safety as well as national development and improvement of public welfare. Food and drug statistics are being used to determine the priorities and directions of policy for the promotion of public health and the development of the health industry. This study focuses on statistics from the MFDS. Through the analysis of the MFDS's statistics, the current status of the MFDS's production statistics was identified, and the survey of utilization and satisfaction of the MFDS's statistics was conducted on food and drug experts who actually use the statistics of the MFDS. In order to identify problems of the MFDS statistics, environmental factors affecting the MFDS statistics were derived, and the priorities of improvement tasks for its statistics were identified using AHP and IPA. In addition, the current situation of the statistical system, which serve as the basic coordinate for the establishment and execution of domestic food and drug policies, was identified and implications were provided.

• YAKHAK HOEJI
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• v.57 no.3
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• pp.205-212
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• 2013

Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the "Manual for Guideline Application for Validation of Analytical Procedures" and "Guidelines on Specification of Dissolution test for Oral dosage form" of Korean Pharmacopoeia (KP), we validated and established each development method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.

• Korean Journal of Microbiology
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• v.54 no.2
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• pp.155-157
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• 2018

Salmonella enterica subsp. enterica serovar Thompson strain MFDS1004024 was isolated from crab-stick in Korean food-borne outbreak in 2014. Here, we present the complete genome sequence of strain MFDS1004024 with a size of 4,742,942 bp and a mean G + C content of 52%. The genome included 4,373 coding sequences, and 22 ribosomal RNA and 84 transfer RNA genes. Also, we found that strain MFDS1004024 has some genes for Salmonella infection and beta-lactam resistance in its genome based on the result of genome analysis.

• Korean Journal of Food Science and Technology
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• v.46 no.1
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• pp.7-12
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• 2014

A sensitive and simple analytical method to identify flutianil residues in agricultural commodities was developed and validated using gas chromatography-electron capture detection (GC-ECD) and mass spectrometry (GC-MS). The flutianil residues were extracted with acetonitrile, partitioned with dichloromethane, and then purified using a silica solid-phase extraction (SPE) cartridge. The method was validated using pepper, sweet pepper, mandarin, hulled rice, soybean, and potato spiked with 0.02 or 0.2 mg/kg flutianil. The average recovery of flutianil was 76.5-108.0% with a relative standard deviation of less than 10%. The limit of detection and limit of quantification were 0.004 and 0.02 mg/kg, respectively. The result of recoveries and relative standard deviation were in line with Codex Alimentarius Commission Guidelines (CAC/GL 40). These results show that the method developed in this study is appropriate for flutianil identification and can be used to maintain the safety of agricultural products containing flutianil residues.

• Journal of Food Hygiene and Safety
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• v.28 no.3
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• pp.222-226
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• 2013

A simple and sensitive analytical method was developed using gas chromatograph with electron capture detector (GC-ECD) and gas chromatograph-mass spectrometer (GC-MS) for determination and identification of chloropicrin. Because of small molecular weight and high volatile properties of chloropicrin, analytical method was developed utilizing headspace extraction and direct injection to the GC. The developed method was validated using hulled rice sample spiked with chloropicrin at different concentration levels, 0.1 and 0.5 mg/kg. Average recoveries of chloropicrin (using each concentration three replicates) ranged 77.7~79.3% with relative standard deviations less than 10% and calibration solutions concentration in the range $0.005{\sim}0.5{\mu}g/mL$, and limit of detection (LOD) and limit of quantification (LOQ) were 0.004 and 0.01 mg/kg, respectively. The result showed that developed analytical methods was successfully applied to detect a small amount of chloropicrin in hulled rice.

• The Journal of KAIRB
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• v.2 no.2
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• Journal of Food Hygiene and Safety
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• v.31 no.3
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• pp.194-200
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• 2016

Aflatoxins and ochratoxin A (AFTs and OTA) are secondary fungal metabolites produced by several moulds, mainly by Aspergillus flavus by Aspergillus ochraceus and Penicillium verrucosum, and these toxins can be transferred to animals and humans through the ingestion of contaminated feed and food. This study was to develop the analytical method for determination the levels of AFTs ($B_1$, $B_2$, $G_1$ and $G_2$) and OTA in pork. The AFTs and OTA were analyzed simultaneously by electrospray ionization in positive ion mode and mass reaction monitoring (MRM) after solid phase extract (SPE) columns clean-up. Performance characteristics, such as accuracy, precision, linear range, limit of detection (LOD) and quantification (LOQ), were also determined. Matrix-matched standard calibration was used for quantification, obtaining the recoveries in the range of 67.3~108.2% with the relative standard deviations of < 20%. Limits of detection and quantification were also estimated, obtaining the limits of quantification ranged in $0.7{\sim}1.3{\mu}g/kg$. The results of the inter-day study, which was performed with pork samples for 3 days, showed an accuracy of 92.0~109.9%. The precisions (expressed as relative standard deviation values) for the inter day variation were 2.6~17.8%. The method developed in this study was able to carry out the analysis with the satisfactory intensity and accuracy.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.212-218
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• 2019

The process of establishing domestic standards on hazardous substances in food safety regulations requires harmonization with standards from the Codex Alimentarius Commission (CAC). For this purpose, food classification by the CAC (Codex Classification of Foods and Animal Feeds) also needs to be clearly understood. Therefore, this paper aimed to introduce the Codex Classification on cereal grains, nuts/seeds and herbs/spices because revisions of the Codex were completed in 2017 for cereal grains and in 2018 for nuts/seeds and herbs/spices. The revised Codex Classification on those foods is briefly summarized as follows. Cereal grains in the domestic food classification by the Ministry of Food and Drug Safety, Korea (MFDS) corresponds to the Codex Group 020 cereal grains with six subgroups. The MFDS's nuts and seeds classification corresponds to three groups in the Codex, namely, Group 022 (tree nuts with no subgroups), Group 023 (oilseeds and oilfruits with 5 subgroups), and Group 024 (seeds for beverages and sweets with no subgroups). The food commodities of herbs and spices are included in two Codex groups, Group 027 (with 3 subgroups) and Group 028 (with 9 subgroups). The number of Codex commodity codes assigned to food commodities was 27 for Group 020, 32 for Group 022, 46 for Group 023, 4 for Group 024, 127 for Group 027 and 138 for Group 028. In between the Codex Classification and the MFDS's classification, some differences are shown. For example, the MFDS did not create a subgroup under groups of cereal grains and herbs. The MFDS classified peanuts into the nut group, though a separate group for oilseeds is present, while the Codex classified peanuts into the oilseed and oilfruit group. In addition, there is also a separate group of "plants, others" present in the MFDS's classification. Therefore, care is needed in using the Codex Classification.

• Korean Journal of Microbiology
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• v.54 no.2
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• pp.164-166
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• 2018

Salmonella enterica subsp. enterica is a foodborne pathogen that has been detected throughout the world. Here, we present the complete genome sequence of Salmonella Enteritidis isolated from a commercial kimbap that caused foodborne illness in the Republic of Korea in 2014. Complete genome sequence analysis of Salmonella Enteritidis MFDS1004839 revealed a 4,679,649 bp chromosome and a 96,994 bp plasmid, with G + C contents of 52.2% and 49.3%, respectively. The chromosome and plasmid genome included 4,482 predicted protein-coding sequences, 84 tRNAs and 22 rRNAs genes.

• Journal of Environmental Health Sciences
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• v.45 no.2
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• pp.134-141
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• 2019

Objectives: The study aimed to investigate the characteristics of health masks and to suggest the proper selection and use of protecting the respiratory system from particulate matters. Methods: The National Standard of masks promulgated by the Ministry of Food and Drug Safety (MFDS) and the Ministry of Employment and Labor (MOEL) were reviewed. The raw data of certified health masks were obtained from the MFDS database. Descriptive statistical analysis was performed. Results: Overall, 543 masks were certified by MFDS as of March 2019. Numbers of certified masks as KF80 (Korea Filter), KF94 and KF99 were 257 (47.3%), 281 (51.8%), and 5 (0.9%), respectively. Names of health masks, which were yellow sand, communicable diseases, health or its combination, were diverse that made customers be confused in selection. Health masks were also classified by particulate size, however, detailed information was not available. Conclusions: We investigated the status of health mask certification in Korea. Appropriate information on KF grade of health masks is required for customers to use them properly. MFDS should update the certification system of health masks periodically.