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Responsibilities of the QA/QC member
Role 품질표준 및 관련법규의 적용에 대한 leadership 제공 제조공정/제품품질 향상에 지속적인 노력 2.1 Regulatory/technical 책임 승인/거절 : 원료, 자재, 제품, SOP, 규격, 분석법, validation 문서, Technical change Interact : 사외 정부기관, 무역업체, 고객, CMO Handling : 소비자불만, 이상발생, 정기검토, 안정성 program, 환경/용수 monitoring trend 기준 및 법규의 이행 확인 2.2 Managerial 책임 교육, GMP 동기부여 정확, 신뢰, 효율, 시기 적절한 시험기능 관리 제품과 공정의 품질을 계량할 지표개발, 이러한 data관리 법규적, 기술적, 품질정보를 전체에 의견교환 품질능력을 벗어난 것에 대한 인식
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Current QA Roles 1. Documentation 2. Qualification and Validation
Documentation system SOP of SOPs Archival Batch Control Record 2. Qualification and Validation Training of Personnel Qualification of Equipment Validation of Process and Methods Qualification of Suppliers Annual Product Review 3. Control System Change Control OOS Investigation / Complaint Deviation Management Self Inspection Hygiene Control Batch Release
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Current QC Roles 1. Documentation 2. Qualification and Validation
Raw Data Archival Master Documents Batch Control Record 2. Qualification and Validation Qualification of Analyst Qualification of Equipment Method Validation 3. Test Sample Management Retention Samples Stability Studies Critical consumers 4. Control System Investigation OOS Investigation Change Control
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