GMP Mock Inspection Service(GMP 모의실사 서비스)

바이오써포트는 2003 년에 GMP진단(Mock Inspection) 컨설팅을 최초로 시작하여 내용고형제, 내용액제, 주사제, 연고제, 항암제, 원료의약품, 생물의약품, 세포치료제 등의 고객사 GMP의 개선, 혁신 그리고 고객사의 부가가치 창조를 위하여 GMP진단을 실행하고 있습니다. 또한, KGMP 및 해외 CGMP, EU GMP, 일본 GMP실사 대응 및 준비를 위하여 GMP진단을 실행하고 있습니다.
GMP진단은 크게 GMP Hardware측면과 GMP Software측면으로 접근하여 목표 GMP요구사항 및 DI(Data Integrity) 요구사항과의 Gap을 분석하고 개선필요사항을 확인하며, 이에 대한 CAPA에 대하여 컨설팅을 실행합니다.

GMP Layout Review: Cross Contamination Prevention, Personnel/Material/Product/Waste Flow Production Area / Quality Control Area / Storage Area / Ancillary Area Computerized System(BMS, LIMS, ERP, MES….) Equipment and Utilities Use and Maintenance Monitoring and Control HVAC System and Clean Room Pharmaceutical Water & Steam System Pharmaceutical Gas System GMP Organization Pharmaceutical Quality System Management Quality Management System Quality Assurance System Quality Control System - Laboratory Control Production Control System Product Contamination Control System Facilities & Equipment Control System Material Control System Validation Management System Documentations Policy, SOP & Form, Specification Batch Instruction & Records Qualification and Validation Process Control Hygiene Control & Cross Contamination Prevention + CCS Data Integrity Material and Finished Product Control Supply Chain Management Complaints and Product Recall Change Control Self Audit Personnel (Re)qualification and (Re)training Worker Interview Others