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History of KGMP
1977 introduction of GMP in korea
1994 implementation of GMP (mandatory)
2008 adoption of pre-approval inspection for all drugs
2014 joined PIC/S as a participating authority
Main policies
1. International hamonization of standards
2. GMP inspection for domestic pharmaceutial (including biologicals)
3. Overseeing GMP FACILITIES OF IMPORTED drugs by overseas inspections
4. Promotion and support new GMP Technologies such as QbD, PAT etc. to the industry
5. Enhance GMP inspectors' expertise and skill by various training programs (including overseas training)
6. Extend international cooperation in GMP area
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