The Ministry of Food and Drug Safety (MFDS) is set to host the first annual seminar on Good Manufacturing Practices (GMP) in collaboration with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The MFDS believes this seminar will enhance the understanding and implementation capabilities of GMP policies among manufacturing companies.
On May 19, the MFDS announced that the seminar will take place at the ST Center in Gangnam, Seoul, targeting representatives from pharmaceutical manufacturing companies. The event will cover trends in GMP policy implementation and share technical insights on aseptic drug GMP compliance.
Topics to be discussed include: the current status of GMP policy implementation, updates on the operation of a global GMP compliance support committee, and trends in GMP inspections by the U.S. Food and Drug Administration (FDA), along with strategies for responding to unannounced inspections. Notably, the policy updates will be broadcast live on the MFDS YouTube channel.
Additionally, the seminar will address industry interests regarding the revision of aseptic drug regulations, including strategies for the operation of the Pre-Use Post-Sterilization Integrity Testing (PUPSIT) and case studies of its application, as well as the latest technological trends in freeze-drying processes and global regulatory developments.
The MFDS stated, "We plan to regularly hold policy briefings and annual seminars to strengthen the GMP compliance capabilities of the pharmaceutical industry and support the harmonization of global regulations."
* This article has been translated by AI.
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