Genexol Plant passed GMP inspections from European governments
In 2004, Samyang Genex Daejeon Plant received GMP inspections by two European governments. Daejeon Plant manufactures paclitaxel (Chemical name: paclitaxel, Brand name: Genexol), an anti-cancer active pharmaceutical ingredient.
Inspection from National Institute of Pharmacy of Hungary was in September of 2004. Dr. Detari, the inspector, inspected for two days (September 13~14). She was very satisfied with the manufacturing facility and the GMP system of Daejeon plant, and the inspection went very smoothly. There were no major deficiencies and only few minor items. In January of 2005, Daejeon plant received the certificate of GMP stating that Daejeon plant is operating according to the guidelines set out by ICH Q7A.
Inspectors from Ministry of Health and Science (Hamburg, Germany) came to inspect in November of 2004. The inspection was requested by Helm AG (German Pharmaceutical Trading Company) to obtain the import license to Hamburg, Germany. Dr. Hoose and Dr. Hosch inspected for three days (November 9~11). As the inspection progressed, both inspectors liked what they saw. The inspection did not find any major deficiencies and few minor items. During the final wrap-up of the inspection, Dr. Hosch expressed his satisfaction for Daejeon plant. He announced that Daejeon plant is operating according to GMP and ICH Q7A and that Daejeon plant will receive the import license. In June of 2005, Samyang Genex Daejeon Plant received the import license, confirming the high quality GMP system that Daejeon plant maintains.
The successful results from both inspections guarantee the basis for export to four Eastern European countries (Hungary, Poland, Czecho, Slovakia) as well as Germany and all other countries in EU through mutual recognition program.
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