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  • [Reporter's View] Strengthening GMP for sterile drugs
  • by Kim, Jin-Gu | translator Alice Kang | May 19, 2025 05:56am
Gov¡¯t needs to consider the companies¡¯ position while strengthening GMP standards for sterile drug products to ensure a stable supply
The government has reaffirmed its existing position on strengthening GMP standards for sterile finished drug products in December. The Ministry of Food and Drug Safety recently met with sterile drug factory managers and stated that there will be no postponement of the enforcement of the ¡°Regulations on Drug Manufacturing and Quality Control¡± in December.

Under these regulations, facilities producing sterile drug products must implement the following measures: ¡ãEstablish and implement a systematic contamination control strategy for the manufacture of sterile drug products; ¡ãDevelop individual good manufacturing practices (GMP) for advanced biopharmaceuticals; ¡ãClarify the details of the specific dosage forms,
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