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  • [Reporter's View] Enhanced GMP reg for sterile drug products
  • by Lee, Hye-Kyung | translator Hong, Ji Yeon | Apr 28, 2025 05:55am
to take effect soon. Are companies prepared for the revision?
Starting December 27, production¡¤good manufacturing practices (GMP) regulations for sterile medicinal products produced by aseptic processing will be strengthened. The Ministry of Food and Drug Safety (MFDS) amended the 'Regulations on Good Manufacturing Practices (GMP) for Medicinal Products' in 2023.

The revision had been conducted to modify the production¡¤good manufacturing practices (GMP) regulations for sterile medicinal products following the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) ahead of the reevaluation by the PIC/S. The guidelines state the establishment of contaminant management methods through GMP regulations and the latest sterile ma
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