变更评估项目表

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

影响方法开发/验证/确认  Impact on local method development/validation/verification

A.4.2

影响方法与相对于法定/供应商方法的等同性 Impact on local method  equivalence (versus

A.4.3

影响批次整体考察 Impact  on batch overview

A.4.4

影响方法转移 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试验 New or update of stability study required

A.6

其他

Logistics

A.6.1

影响当地相关产品 Impact  on locally related products

A.6.2

需告知采购/供应/发运  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

影响法规文件符合性 Impact  on local regulatory specification documents

A.8.2

需要备案 Need  for local filing

A.8.3

等待批准方可实施 Implementation  wait for approval

B

合同方／供应商／物料（原料, 包材, 成品）

Contractor/Supplier / Material

(RawMaterials - 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

影响企业标准文件 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.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 of(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

影响当地法规所规定的制造方法 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

影响分析方法 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

稳定性试验 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 Artwork

B.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

影响供应商的检验报告书 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

其他

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

与销售国的法规冲突 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

培训 Training

C.1.2

文件修订 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

稳定性试验 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

其他

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

需要备案 Need  for filing in FDA

C.4.2

审批后执行 Implementation  after approval

D  设备／设施

Equipment -Facilities - Utilities

D.1

概述 

General

D.1.1

培训Training

D.1.2

需要更新文件 Update  of documents required

* 操作程序  Update Operational procedures

* 清洁程序  Update Cleaning procedure

* 维修／校验程序  Update Maintenance/Calibration procedure

* 批记录  Update Batch Production Record (BPR)

* 设备备件标准  Update specification of equipment parts (=components)

* 系统描述  Update system description

* 更新布局图  Update lay-out drawing

* 房间的洁净级别  Update room classification plan

* 相关电机或气动原理图  Update electrical - mechanical or pneumatic drawing

* PID 图纸  Update of P&ID (process and instrumental diagram)  required ?

D.2 GMP

D.2.1

确认Qualification

* 更新验证主计划  Update VMP (Validation Master Plan)

* 用户需求规范  （URS） Issue URS (User Requirements  Specifications)

* 风险评估（RA） Issue Risk  Assessment

* 项目验证计划  （P&QP） Issue Project qualification plan

* 厂方接收测试（FAT） Issue  Factory acceptance test

* 设计确认  （DQ） Issue DQ (Design qualification)

* 安装确认  （IQ） Issue IQ (installation  qualification)

* 运行确认（OQ） issue OQ  (operation qualification)

* 性能确认（PQ）issue PQ  (performance qualification)

* 确认总结报告（QSR）Issue  Qualification Summary Report

D.2.2

更新预防维护计划 Update  Preventive Maintenance plan (program)

更新预防维护指南／清单 Update  Preventive Maintenance instruction/ checklist

更新校准计划 Update  calibration program

更新校准记录 Update  calibration records

需要校准 Need  Calibration

D.2.3

功能测试(方案/报告）Functionality test （ protocol /report)

D.2.4

需要提供材料证明/精确度/光洁度证明  Certificate for material, accuracy or finishing

D.2.5

设备标识 Labeling  of equipment

D.2.6

自动化（计算机化）系统 Automated  (computerized) systems

* 计算机验证  Computer system validation

D.2.7

影响环境监测（微生物，物理及化学）Impact on environmental monitoring (microbiology, physical, chemical)

D.2.8

设备台帐日志 New  logbooks

D.3             其他  

Logistics

D.3.1

影响相关设备 Affect  related equipment

D.3.2

需要采购／供应商／发运确认 Need to inform Purchasing and/or suppliers and/or distribution (=  update

D.3.3

需要签署新的或更新质量协议 New (or update) Quality Agreement with contractor

D.4 法规  

Regulatory

D.4.1

需要在销售国政府机关备案 Need for marketing countries filing

D.4.2

等待批准后才实施 Implementation  wait for approval

E  环境、健康及安全 

EHS

E.1                 安全 

Safety

E.1.1

人员的安全 Risk  for the safety of persons

* 工业的风险：爆沸，坠落  By an industrial risk: bumping, falling

* 移动的部件或热的表面  By moving parts and/or hot surfaces

* 噪音，高热，压力，放射性的电离辐射，非电离辐射（如激光），生物制品及振动By

* 危险或高活性物料（致癌物质，激素，OEL,..）By hazardous materials (carcinogens,

* 电击  By electrocution

* 静电  By static electricity

E.1.2

设备的安全 Impact  on the safety of equipment

* 超过／低于压力  Over/under pressure

* 过量灌装  Overfilling

* 报警，互锁，控制及监视系统  Alarm, interlock, control & monitoring system

* 设备是否有零进入的安全防护装置  Zero access machine guarding

* 设备具有一定机械强度（对设备，管道，建筑，地面等的使用过程）  Mechanical strength

* 设备耐腐蚀  （工艺设备，管道等） Corrosion  resistance (process equipment, pipes) of

* 兼容物料和生产设备  Compatibility of materials/production equipment

E.1.3

引入新的风险（对于操作和维修） Introduce a risk on accessibility（operation and maintenance）

E.1.4

是否影响风险的识别和评估（危险源的识别，暴露区域的识别，剩余风险的评估，方法的描述，安置的顺序）

* 关键的安全系统／设备／元器件  Safety-critical system/equipment/component

* 爆炸的风险  explosion risks

E.1.5

需要被下列部门／人员控制，检查或评估 Control, inspection or evaluation is needed by :

* 安全部  Safety department

* 工业卫生人员（测量噪音，光照，温度，化学物质) Industrial hygienist (measurement:

* 职业健康医师  Occupational health physician

* 独立的权威的检查机构  Independent authorized inspection body (pressurized

E.1.6

是否影响安全验证或测试程序 The change have an impact on safety validation/test procedure

E.1.7

是否影响设备的安全证明 The  change have an impact on safety certificates of equipment

E.1.8

是否影响安全指令／程序／公司政策（运行／维修／紧急情况／启动）  The change have an

E.1.9

是否带来人机工程学风险 The  change introduce an ergonomic risk

E.1.10

是否会引入新的限制区 The  change introduce confined spaces

* 在限制区上方是否需要锚定点  Anchoring points are required above confined spaces

E.1.11

生产流程中碎玻璃的污染是否被排除或减少到最低程度 Process glass been eliminated or

E.1.12

对厂区安全设施布置图的影响 Impact on site safety drawings

E.1.13

影响消防（洒水车，便携式灭火器）及紧急响应系统（火警，烟雾检测，应急照明）  Impact

E.1.14

影响当地的泄漏程序及设备 Impact on the local spill procedure & equipment

E.1.15

影响设备的标识 Impact  on labeling of equipment

E.2           环境  

Environment

E.2.1

影响环境许可（受监管物质，放射性，电离－非电离剂，麻醉品，..) Impact on the environmental permit (regulated substances,  radioactivity, ionizing & non-ionizing agents, narcotics,…)

E.2.2

影响建筑许可 Impact  on the building permit

E.2.3

影响地区规划(植树,绿地) Impact on the regional planning (planting, green space)

E.2.4

影响对大气的排放 Impact  on air emissions in the atmosphere

* 排放有机物  Emission of organic substances

* 排放无机物  Emission of inorganic substances

* 排放CO2 Emission of CO2

* 排放较低/较高的臭味 Emission  of a lower/higher odor

* 使用对臭氧层造成危害的物质（如氟利昂）？  Does the change involves the use of substances dangerous for  ozone layer (e.g. Freon)?

E.2.5

影响水的消耗 Impact  on consumption of water

E.2.6

对废水的影响 (收集和处理) Impact on waste water  (collection & discharge of water)

E.2.7

引入前是否需要合适的清洁方法 Require an adapted cleaning method before introduction

E.2.8

废物的影响 Impact  on waste

* 产生危险废物(液体,固体,气体,石棉)  Generation of hazardous waste (liquid, solid, gas,

* 产生无害废物(液体,固体,气体) Generation of non-hazardous waste (liquid, solid, gas)

* 废物  (液体,固体,气体)的处置和运输  Waste logistics (liquid, solid, gas)

E.2.9

影响外部噪音(对周围环境的噪音水平) Impact on external  noise (noise level to surrounding

E.2.10

对土壤的影响 Impact  on soil

E.2.11

影响危险物质的储存及使用 Impact on hazardous substances (storage & use)

E.2.12

需评估以确保有效的能源设计 The modification need be assessed to ensure an energy efficient

E.2.15

需要来自一个独立的\权威的检查机构的控制或检查 Inspection needed by  an independent

E.2.16

对当前的环境监测程序的影响 Impact on the current environmental monitoring program

E.3

健康 

Health

E.3.1

需采取控制措施减少个人健康和安全风险Controls been applied to minimize the H&S risk to

E.3.2

对MSDS 的影响 Impact on the Material Safety  Data Sheet database and

E.3.3

使用不合法的化学品 Involve  use of chemical substances that have not been codified

E.3.4

影响个人防护用品（PPE） Impact on Personal Protective  Equipment (PPE)

* 建立相关PPE 储存， 清洗和净化规定  Provision for storage, cleaning and

* 需要供给呼吸用的空气  Requirement for breathing air