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Pharmaceuticals
FDA · EMA · MFDS · PMDA · NMPA
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US FDA
EU EMA
Korea MFDS (식약처)
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식품의약품안전처 KGMP & 글로벌 진단
Target Regulatory Standard
🇰🇷 Korea MFDS (식품의약품안전처)
🇺🇸 US FDA (미국 21 CFR)
🇪🇺 EU EMA (유럽 EudraLex Annex 15)
🇨🇳 China NMPA (중국 CSAR)
🇯🇵 Japan PMDA (일본)
Commercial Product Name
Commercial Batch Size
HBEL / PDE Toxicological Report
❌ 세척 밸리데이션 독성평가보고서(HBEL/PDE) 미비
✅ Complete HBEL/PDE Report Present
Process Validation (PV) Age
⚠️ 4년 경과 (공정 PV 3년 재검증 주기 초과!)
✅ 1년 경과 (유효)
⚡ Run Regulatory Gap Diagnosis
GMP Compliance Health Score
CRITICAL_RISK
65
CRITICAL
1
Deficiencies
MAJOR
0
Deficiencies
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