Daejeon Genexol Plant passed Korean DMF inspection
Samyang Genex Daejeon Plant (Plant Manager: Bong-Kyu Song) received the DMF inspection from KFDA on August 4th. The inspection covered the entire plant from manufacturing facilities to GMP system. The inspection was successful, and pronounced CGMP Operation upon Daejeon Plant at the end of the inspection.
The result was officially posted on the news page at KFDA webpage on August 10th. Most interestingly, the results from recent inspections show that only Samyang Genex and Abbott Korea passed the inspection among anti-biotic & anti-cancer drug companies, and among paclitaxel API manufacturers, Samyang Genex is the only company that passed the inspection at this time (Foreign manufacturers will be inspected in later dates).
Considering that most companies have received the orders to amend their DMF or to upgrade and update the manufacturing & GMP system, the GMP status at Daejeon Plant is at the top among the pharmaceutical manufacturers in Korea. Meanwhile, upon request from KFDA, Daejeon plant will train new KFDA inspectors on GMP system and GMP manufacturing facility during September.
* DMF: Drug Master File * KFDA: Korea Food & Drug Administration * CGMP: Current Good Manufacturing Practice * API: Active Pharmaceutical Ingredient
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