变更评估项目表
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
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
validation verificationB.2.4 影响贮存条件 Impact on storage conditions
B.2.5 影响取样 Impact on sampling
B.2.6 需更新（通常的）交货条件 Update o(general) delivery conditions
B.2.7 影响合格供应商清单 Impact on approved vendor list
B.2.8 影响包装工艺 Impact on packaging instructions
B.2.9
影响当地法规中所描述的制造方法 Impact on manufacturing method description in local regulatory
Files


B.3 实验室设备 Lab Equipment
B.3.1 需要新设备 New equipment needed
B.3.2 （新）设备需确认／校验 (New) equipment to be qualified / calibrated

B.4 分析 Analytics
B.4.1 影响检验方法 Impact on test method
B.4.2 与供户的方法进行比较 Method comparison with supplier
B.4.3 提供质量标准给供应商 Specification needed be transferred to supplier
B.4.4 影响免检 Impact on reduced testing
B.4.5 需送小样进行检验 Samples need be supplied for test
B.4.6 需合同实验室来检验 Contract lab involved for testing

B.5 体系/质量 System／Quality
B.5.1
稳定性研究 Impact on stability studies
* 加速稳定性考察 Accelerated stability test
* 长期稳定性考察 Long time stability test
B.5.2
供应商情况调研 Questionnaire purchasing
* 营业执照，生产许可证，危险化学品生产（经营、运输）许可证；药包材注册证 Certificate
status
* ISO9001／ISO14001 认证 ISO9001／ISO14001 compliance
B.5.3 影响产品效期 Impact shelf life
B.5.4 试机 Trial running
B.5.5
工艺验证 Impact on process validation
* 验证方案 Protocol
* 验证报告 Report
* 验证次数 Number of runs
B.5.6 影响包材设计 Impact on design of ArtworkB.5.7 供应商审计 Audit supplier
B.5.8 特殊释放 Need specific release
B.5.9 试验(特征）批 Need trial batches
B.5.10 影响供户的产品质量证书 Impact on CoA of supplier
B.6 市场 Markets
B.6.1 需要通知销售部 Notification sale(s)
B.6.2 需要销售部批准 Approval sale(s)
B.7 物流 Logistics
B.7.1 涉及其他的生产场所/承包商 Involve other manufacturing sites / contractors
B.7.2 影响进程中的订单 Change applicable to orders already in progress
B.7.3 影响库存 Impact on stock
B.8 法规 Regulatory
B.8.1 与销售国法规冲突 Impact on marketing countries regulatory requirements
B.8.2 需要在销售国政府机关备案 Need for marketing countries filing
B.8.3 需审批后执行 Implementation after approval
B.8.6 影响残留溶剂/挥发性有机杂质 Impact on residual solvents / organic volatile impurities (OVI)
C 生产工艺
Production Processes
C.1 概述 General
C.1.1 进行培训 Training
C.1.2
文件 Update documents (weighing, filing, manufacturing, packaging)
* 管理／操作程序 Update procedures
* 工艺路线数据表 Routing Data Collection Form
* 工艺规程 MPI
* 批记录BPR Update Batch Production Record
C.2 GMP
C.2.1
工艺验证 Process Validation
* 验证方案 Protocol
* 验证报告 Report
* 验证次数 Number of runs
* 再验证( Re)-validation
C.2.2
清洁验证 Cleaning validation
* 验证方案 protocol
* 验证报告 Report
* 验证次数 Number of runs
* 再验证( Re)-validation
C.2.3 稳定性研究 Stability studies
* 加速稳定性考察 Accelerated stability test
* 长期稳定性考察 Long time stability test
C.2.4 微生物评估 Microbiological assessment
C.2.5 影响批量 Impact on the Batch Size
C.2.6 物料编码清单 Update material code list
C.2.7 设备清单 Update equipment list
C.3 物流Logistics
C.3.1 影响到相关产品 Affect related products
C.3.2 涉及到其他的生产地或合同方 Other manufacturing sites / contractors involved
C.3.3 升版或起草质量协议 Need to draft new (or update) Quality Agreement
C.3.4 限制产品配送 Restrictions to product distribution
C.3.5 创建或改变物料／产品编码 Create / changed material /product codes
C.3.6 影响到供应商 Impact on suppliers
C.4 法规 Regulatory
C.4.1 相关信息/支持文件备案 Need for filing in SFDA/PFDA
C.4.2 审批后执行 Implementation after approval