The Ministry of Food and Drug Safety has published updated Good Manufacturing Practice (GMP) evaluation guidelines for pharmaceuticals, outlining assessment procedures, standards, and administrative processes.
Key Updates:
- Expanded Scope: Broader principles, methods, and review standards for compliance assessment.
- Evaluation Process: Includes document reviews, on-site investigations, and assessment periods.
- Submission Requirements: 11 types of required data, including manufacturing floor plans, facility management records, and environmental controls.
- Non-Face-to-Face Inspections: Conducted via video conferencing, lasting 4 to 8 hours per day, with 2–3 GMP inspectors.
- These guidelines ensure pharmaceutical manufacturing meets strict quality and safety standards.
Region: East Asia
Source: https://www.mfds.go.kr/brd/m_1059/view.do?seq=15140&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
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February 2025
