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@article{ART001824934},
author={김정연 and Kwon, Kyenghee},
title={A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea},
journal={Crisisonomy},
issn={2466-1198},
year={2013},
volume={9},
number={11},
pages={239-272}

TY - JOUR
AU - 김정연
AU - Kwon, Kyenghee
TI - A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea
JO - Crisisonomy
PY - 2013
VL - 9
IS - 11
PB - Crisis and Emergency Management: Theory and Praxis
SP - 239
EP - 272
SN - 2466-1198
AB - Despite progresses since the Korea GMP in 1994, there still appears deficiencies such as the recent recall issue of children’s antipyretic oral suspension. To overcome this limitation, those countries like US have introduces Quality by Design and Quality Risk Management, which Korea needs to adopt yet. This study compared the GMP and the relevant regulations of Korea with those of US, EU and ICH. The result suggests as follows; first, strategy for establishing infrastructure for QbD and QRM, Second, draft GMP revision to adopt risk management. Third, draft approval regulation for QbD/QRM products, Fourth, the need for introducing risk-based approach, fifth, industry’s early adoption of QbD/QRM.
KW - quality by design;quality risk management;GMP
DO -
UR -
ER -

김정연 and Kwon, Kyenghee. (2013). A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea. Crisisonomy, 9(11), 239-272.

김정연 and Kwon, Kyenghee. 2013, "A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea", Crisisonomy, vol.9, no.11 pp.239-272.

김정연, Kwon, Kyenghee "A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea" Crisisonomy 9.11 pp.239-272 (2013) : 239.

김정연, Kwon, Kyenghee. A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea. 2013; 9(11), 239-272.

김정연 and Kwon, Kyenghee. "A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea" Crisisonomy 9, no.11 (2013) : 239-272.

김정연; Kwon, Kyenghee. A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea. Crisisonomy, 9(11), 239-272.

김정연; Kwon, Kyenghee. A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea. Crisisonomy. 2013; 9(11) 239-272.

김정연, Kwon, Kyenghee. A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea. 2013; 9(11), 239-272.

김정연 and Kwon, Kyenghee. "A Study on the Status of Pharmaceutical Quality Management System in the Persepctive of Recall Issue of Children’s Antipyretic Oral Suspension and Introducing Advanced Management Model in Korea" Crisisonomy 9, no.11 (2013) : 239-272.