GMP Consulting
GENERAL PRINCIPLES
PIC/S 및 KVGMP 관련 규정을 기반으로 Audit Checklist 개발하고 이에 따라 서류 및 현장 점검을 진행한 후, 도출된 보완 사항에 대해 심각도 분류 및 보고서를 제출하며, 결과에 따른 시정 및 보완 사항을 제시하여 전체적인 제조소의 제조 및 품질 관리 시스템을 개선합니다.
AUDIT PLANING
- QUALITY DOCUMENT
- DRAWING
- MANUFACTURING PROCESS
- BUSINESS
- AUDIT AGENDA & CHECK LIST
AUDIT
- KICK OFF MEETING
- SITE INSPECTION
- PROCESS INSPECTION
- DOCUMENT INSPECTION
- WRAP UP MEETING
- AUDIT REPORT
CAPA
- CORRECTIVE ACTION
- PREVENTIVE ACTION
FLOW PLAN
Kick-Off Meeting
introduce, inspection goal setting
System Review
site, facility, equipment, manufacturing process, quality system, document system, laboratory system, etc.,
Agenda, Check List Develop
agenda, inspection check list preparation
Trainning
education for inspection
Inspection
site inspection, document inspection, personal inspection
Report
classification inspection result, inspection report preparation
CAPA
education for corrective action and preventive action, review plan
Final Report
final report preparation with CAPA result
GENERAL PRINCIPLES
PIC/S 및 GMP 관련 규정 및 ICH Q9 Quality risk management, Q10 Pharmaceutical quality system을 참고하여 업체의 운영 전략에 적합한 문서 시스템 개선 및 구축해드립니다.
GAP ANALYSIS
- SITE
- PROCESS
- DOCUMENT
- SYSTEM
- PERSONAL
- BUSINESS
SUPPLEMENTATION
- GMP DOCUMENT
- BATCH RECORD
- RAW DATA MANAGEMENT
FLOW PLAN
Kick-Off Meeting
introduce, supplementation goal setting
Gap Analysis
manufacturing process, document, personal, business
Report
gap analysis report with supplementation plan
Preparation
SOP, GMP document preparation and review
Trainning
document system, management strategy
Final Review
final review and management system