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  • Measures to reduce industry burden for stronger GMP
  • by Lee, Hye-Kyung | translator Alice Kang | Jun 12, 2025 06:04am
Government and industry prepare measures to reduce the burden brought by stronger GMP enforced on aseptic drugs
KPBMA researches standards for large-volume IV solutions with HK Inno.N, JW Pharmaceutical, Dai Han Pharm
MFDS plans to establish guidelines for contamination control strategies, PUPSIT, etc.
With the Ministry of Food and Drug Safety set to enforce the revised GMP standards for aseptic drugs reflecting the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards from December, measures are being prepared by the industry to reduce its burden.

Ahead of its rejoin into PIC/S in 2023, the MFDS announced the ¡°Regulations on Drug Manufacturing and Quality Control (MFDS Notice)¡± which outlines a risk-based, systematic contamination control strategy to enhance the quality assurance of aseptic pharmaceuticals.

At the time, in consideration of the need for sufficient preparation time for all pharmaceutical companies to establish contamination management strategies, the government decided to
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