GMP certification required by KFDA

21 Sep

GMP certification required by KFDA

Samyoung Unitech produces radiopharmaceuticals and is the first Korean company to manufacture cyclotrons. Samyoung Unitech built a GMP plant in Daejeon and which has been operating to keep pace with the global changes in the market. The Korean Food and Drug Administration reported earlier this year, radiopharmaceuticals was added to the list that requires GMP certification starting from July, 2015. The products of Samyoung including DATrace-123, Tc99m, and Iodidne-131 now became mandatory to acquire GMP certification. Samyoung’s GMP Plant in Daejeon fully equips a facility that produces radioisotopes including Cyclotron and Hotcell and operates manufacturing twice a week. GMP stands for Good Manufacturing Practice and is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks
involved in any pharmaceutical production that cannot be eliminated through testing the final product. Many pharmaceutical companies already have GMP certification and it allows a company to be more global and has more competitiveness in market. To find out more about the new regulations from Korean Food and Drug Administration, please follow the link below.

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