• Title/Summary/Keyword: Risk Management Plan (RMP)

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A Study on Improving Korea's Regulatory System for Pharmaceutical Safety Management (의약품 안전성 관리를 위한 연구 - 의약품 안전관리 제도개선 방안을 중심으로 -)

  • Chae, Gyu Han;Cho, Gi Won;Nagata, Ryuji;Park, Ji Sun;Hong, Chong Hui;Kang, Jong Seong
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.173-186
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    • 2013
  • To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

A Study on the Simplified Estimating Method of Off-site Consequence Analysis by Concentration of Hydrochloric Acid (염산수용액의 농도별 간이 영향 평가 방법 연구)

  • Jung, Y.k.;Kim, B.;Heo, H.;Yoo, B.;Sin, C.;Yoon, Y.;Yoon, J.;Ma, B.
    • Journal of the Korean Society of Safety
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    • v.32 no.2
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    • pp.52-58
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    • 2017
  • One of the most important elements of the management of chemical accident is threat zone estimation of fires, explosions and toxic gas dispersion based on chemical releases. The threat zone estimation is going to be standard of emergency response for the first defender and base line data of off-site risk assesment (hereinafter referred to as "ORA") and risk management plan (hereinafter referred to as "RMP"). Generally, ALOHA form EPA(U.S.) and Kora(from KOREA MINISTRY OF ENVIRONMENT) has been used for the off-site consequence analysis in Korea. However it is hard to predict accurate consequences rapidly in case of emergency. Hydrochloric acid is a multipurpose raw material used in many industrial applications such as chemical, metal and food industries. It is usually treated in concentrations from 10 ~ 35 %, and release accident have occurred frequently. In this study, we have developed a simplified estimating method and equation to calculate threat zone easily in case of emergency due to release accident of hydrochloric acid.

A Study on Prevention Measure Establishment through Cause Analysis of Chemical-Accidents (화학사고 원인분석을 통한 예방대책 수립에 관한 연구)

  • Lee, Hyung-Sub;Yim, Ji-Pyo
    • Journal of the Korean Society of Safety
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    • v.32 no.3
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    • pp.21-27
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    • 2017
  • Even if several chemical accident prevention systems such as PSM(Process Safety Management), RMP(Risk Management Plan), etc. have been carried out, many chemical accidents have still occurred at industrial plants in Korea. We describe the status of chemical industry and the trend of occurrence of chemical accidents in Korea. And this paper analyzes the recent chemical accidents in eight ways. These ways include chemical accident forms, ignition sources, sources of chemical equipment, human vs equipment/material causes, worker's working situation, employee scale, hazardous substances, week & time, fatalities of manufacture & contractor's workers. Finally we proposes the four representative prevention measures brought to result of cause analysis by accident statistics.

A Study on the Simplified Estimating Method of Off-site Consequence Analysis for Aqueous Ammonia (암모니아수의 농도별 간이 영향평가 방법 연구)

  • Jung, Yu-kyung;Heo, Hwajin;Yoo, Byungtae;Yoon, Yi;Yoon, Junheon;Ma, Byungchol
    • Journal of the Korean Institute of Gas
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    • v.20 no.2
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    • pp.49-57
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    • 2016
  • Aqueous ammonia is widely used in household cleaners, fertilizers and denitrification process. It is usually treated in concentrations from 10 % to 30 %, and release accidents have occurred frequently. In this study, we developed a simplified estimating method and equation to calculate threat zone easily in case of emergency due to release accident of aqueous ammonia. We calculated the consequence distance for toxic endpoints of aqueous ammonia(concentration 10 % ~ 30 %) at different puddle areas($1m^2{\sim}500m^2$) using the ALOHA program. Based on the result, we analyzed the relationship between concentration and puddle area with the threat zone and created the equation.

Improvement on the System of Information to the Public for Chemical Accident Emergency Response (화학사고 응급정보에 대한 주민제공 체계 개선 방안)

  • Park, Hyesong;Song, Chi-sun;Shin, Chang-Hyun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.4
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    • pp.571-579
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    • 2019
  • To minimize the damage from chemical accidents, a risk management plan (RMP) has been implemented since 2015. According to this regulation, operators who handle more than the designated quantity of the accident preparedness chemicals should provide emergency response information to the public within the affected areas of accidents. The information, including chemicals, affected areas and evacuation instructions should be provided to the public in advance so that they can evacuate immediately in the event of a chemical accident. Currently, the information notification can be provided in various methods by being registered in the notification system, sent with written documents or delivered directly to the public. To examine the status of the operation method, this study analyzed similar cases overseas, investigated the degree of awareness of providing information through the number of the annual visitor of the Information Provision System, and obtained survey results from some residents. This current operation method are problems because the public, who do not have sufficient information about chemicals, do not understand the emergency information properly or it is difficult to recognize where the residents should find this information because of the convenient operation based on the information provider. In this study, measures were proposed to minimize the damage by making it easier for the public to understand the emergency information and the information communicated appropriately in advance by dividing them into an information providing method and post management.