The Korean pharmaceutical industry has invested over USD 2.6billion to build a production infrastructure that conforms to U.S. CGMPs through the GMP advancement project initiated in the mid-2000s. The joining of PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) by the Ministry of Food and Drug Safety in 2014 is also expected to further increase the global standing of the Korean pharmaceutical industry and bolster its exports.
An International organization formed in 1995 by advanced countries in pharmaceuticals for the purpose of harmonizing pharmaceutical manufacturing with quality control standards (GMP) and improving the quality of inspection. Various benefits are granted to member countries, including exemption from physical inspection before export, through mutual recognition agreements between countries concerning GMP inspection.
QbD is a concept that merges the current dual systems of manufacturing process and quality control into one system, in order to build a quality control system by using cutting-edge technology to predict and cope with the threats that might occur in the process of manufacturing pharmaceutical products. It is an international standard that was established at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is led by the USA, Europe, and Japan. The Ministry of Food and Drug Safety is in the process of building the infrastructure to introduce the system through developing models with QbD applied by dosage form and basic technology.