Conceptual Design
Product Scope: 원료의약품 (CBD Isolate)
Period: 2025 ~ 2026
Certification Goal: KGMP
Consulting Scope: Conceptual Design Development for KGMP compliance
Product Scope: 완제의약품
Period: 2025 ~ 2026
Certification Goal: KGMP
Consulting Scope: Conceptual Design Development for KGMP compliance
GMP Consulting
Product Scope: 의료기기 (4등급)
Period: 2025
Certification Goal: ISO 13485 / GMP
Consulting Scope: ISO 13485 문서 구축, 의료기기 GMP 제조소 문서 구축
Product Scope: 방사성의약품
Period: 2025
Certification Goal: GMP
Consulting Scope: 오염관리전략(CCS) 컨설팅
Product Scope: 기능성원료
Period: 2025
Certification Goal: GMP
Consulting Scope: 기준서 및 SOP 시스템 구축, Mock Audit 및 CAPA 자문
Product Scope: 원료의약품
Period: 2025 ~ 2026
Certification Goal: GMP
Consulting Scope: 기준서 및 SOP 시스템 보완, DI 시스템 기반 강화, GMP 운영체계 개선
Product Scope: 첨단바이오의약품
Period: 2025 ~ 2026
Certification Goal: GMP
Consulting Scope: PQS 개선 컨설팅
Validation & Qualification
□ HVAC System Qualification
□ Air/Gas System Qualification
□ Water System Qualification
□ 보관소 Qualification
□ HVAC System Qualification
□ Pass Box/Clean Bench Qualification
□ Gas System Qualification
□ 보관소 Qualification
□ 제조설비 Qualification
□ HVAC System Qualification
□ Pass Box Qualification
□ 보관소 Qualification
□ VMP / IA / RA
□ HVAC System Qualification
□ Pass Box/Through Qualification
□ Water System Qualification
□ Pure Steam Qualification
□ Air/Gas System Qualification
□ 보관소 Qualification
□ 제조설비 Qualification
□ 제조설비 CSV
□ HVAC System Re-Qualification
□ Air/Gas System Re-Qualification
□ HVAC System Qualification
□ Pass Box/Through Qualification
□ Air/Gas System Qualification
□ 보관소 Qualification
□ 제조설비 Qualification
□ 생산/품질 장비 CSV
□ HVAC System Qualification
□ 제조설비 Qualification
□ HVAC System Qualification
□ Pass Box/Booth Qualification
□ 보관소 Qualification
□ 제조설비 Qualification
□ Air System Qualification
□ HVAC System Qualification
□ HVAC System Re-Qualification
□ 멸균기, 클린부스 Re-Qualification
□ 보관소 Qualification
□ HVAC System Qualification
□ Pass Box Qualification
□ HVAC System Qualification
□ Pass Box/Booth Qualification
□ HVAC System Qualification
□ Pass Box Qualification
□ HVAC System Qualification
□ Pass Box Qualification
□ HVAC System Qualification
□ Pass Box Qualification
□ BSC 외 5종 Qualification
□ HVAC System Qualification
□ HVAC System Qualification
□ HVAC System Qualification
□ HVAC System Qualification
□ Cleanroom Classification
□ HVAC System Qualification
□ 샘플링포인트 선정 RA
□ Dry Oven 외 5종 Qualification
□ Mapping Test
□ Air System Qualification
□ 살균기 Qualification
□ 전자저울, 라벨카운터 Qualification
□ EMS/CMS CSV
□ Air System Monitoring
□ BSC 외 5종 Qualification
□ BSC 외 5종 Qualification
□ 항온항습기 Qualification
□ 항온항습기 Qualification
□ 보관소 Qualification
□ 멸균기 Qualification
□ PCR Qualification
□ Gas System Qualification
□ 진공건조기 Qualification
□ 배양기 외 3종 Qualification
□ 제조설비 Qualification
□ 품질장비 Qualification
□ 분석장비 CSV
□ 제조설비 Qualification
□ 제조설비 CSV
□ 냉장/냉동고 Qualification
□ Pass Box Qualification
□ Clean Booth Qualification
□ BSC 외 7종 장비 Qualification
□ Mapping Test
□ 건열멸균기 Qualification
□ Air System Qualification
□ BSC Qualification
□ 냉동고 외 2종 Qualification
□ 제조설비 Qualification
□ VHP Pass Box Qualification
□ Air/Gas System Qualification
□ 증기멸균기 Qualification
□ BSC Qualification
□ BSC 외 6종 Qualification
□ CRF 외 7종 Qualification
□ Dry Oven Qualification
□ 분쇄기 Qualification
□ 보관소 Qualification
□ BSC 외 5종 Re-Qualification
□ Clean Bench Qualification
□ 멸균기 Qualification
□ 청정실 환경모니터링 수행
□ 고압분산기 Qualification
□ 충전기 Qualification
□ 바이알 씰링기 Qualification
환경모니터링
□ 청정실 환경모니터링 수행
□ 청정실 환경모니터링 수행
□ 압축공기 모니터링
□ Mapping Test
□ 청정실 환경모니터링 수행
□ 멸균기 Qualification
□ 청정실 환경모니터링 수행
□ 청정실 환경모니터링 수행
□ 청정실 환경모니터링 수행
