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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
  • Abbr : KRCEM
  • 2013, 9(11), pp.239-272
  • Publisher : Crisis and Emergency Management: Theory and Praxis
  • Research Area : Social Science > Public Policy > Public Policy in general

김정연 1 Kwon, Kyenghee 1

1동국대학교

Accredited

ABSTRACT

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.

Citation status

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