变更评估项目表.docVIP

项目号 评估项目 Item No. 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) equipment to be qualified / calibrated A.4 分析 Analytics A.4.1 影响当地方法的开发/验证/确认 Impact on local method development/validation/verification A.4.2 影响当地方法的等同性(相对于法规/供户方法) Impact on local method equivalence (versus regulatory / supplier method) A.4.3 影响批次整体考察 Impact on batch overview A.4.4 影响方法传送 Impact on method transfer A.4.5 影响免检 Impact on reduced testing A.4.6 影响对照品 Impact on reference standards A.5 体系 System A.5.1 需要新的或更新稳定性研究 New or update of stability study required A.6 物流 Logistics A.6.1 影响当地相关产品 Impact on locally related products A.6.2 需告知购买／配送 Need to inform Purchasing and/or suppliers and/or distribution A.6.3 需提供质量标准给供应商 Specification needed be transferred to supplier A.6.4 需要新的或升级质量协议 New (or update) Quality Agreement A.6.5 需要更改已处理的订单 Change applicable to orders already in progress A.6.6 影响库存 Impact on stock A.6.7 限制产品的配送 Restrictions to product distribution A.8 法规 Regulatory A.8.1 与当地的法规文件符合性 Impact on local regulatory specification documents A.8.2 需要在当地政府机关备案 Need for local filing A.8.3 等待批准后才实施 Implementation wait for approval B 合同方／供应商／物料（原料, 包材, 成品） Contractor/Supplier / Material (Raw Materials - Packaging Materials-Finished Products) B.1 人员 People B.1.1 实施培训 Training B.2 文件 Documents B.2.1 影响当地的内部标准文件 Impact on local in-house specification documents B.2.2 需要批准供应商所签署的标准文件 Approval sign off on specification documents by supplier B.2.3 变更包装形式 Change to packaging type B.