GMP变更评估.pdfVIP

变更评估项目Assessment Item A 标准方法（原料，成品和包材）Specs Methods (Raw materials - Finished products - Packaging Materials) A.1 人员 People A.1.1 实施培训 Training A.2 文件 Documents A.2.1 影响对规程/内控标准 Impact on procedures /in-house specification A.2.2 新质量标准的合理性说明 Justification of new specification(s) A.2.3 需微生物评估 Microbiological assessment A.2.4 文件的传送／接收 Impact on transfer documents received/sent A.2.5 影响取样原则和方案 Impact on sampling instructions A.2.6 需供应商批准和签字确认 Approval Sign off by supplier A.3 实验室设备 Lab equipment A.3.1 需要新设备 New equipment A.3.2 (新)设备验证／校验 (New) e