《变更评估项目表》

1、项目号Item No.评估项目Assessment ItemA 标准方法(原料，成品和包材Specs Methods (Raw materials - Finished products - Packaging Materials)A. 1 人员 PeopleA. L 1实施培训TrainingA. 2 文件 DocumentsA 2 1 影响对规程/内控标准 Impact on procedures /in-house specificationA. 2. 2 新质fit标准的合理性说明 Justification of new specification(s)A. 2 3 需微生物评估 M

2、icrobiological assessmentA. 2. 4 文件的传送 / 接收 Impact on transfer documents received/sentA25影响取样原则和方案Impact on sampling instructionsA26需供应商批准和签字确认Approval & Sign off by supplierA. 3实验室设备Lab equipmentA. 3. 1 需婆新设备 New equipmentA 2 (新)设备验证 / 校验(New) equipment to be qualified / calibratedA. 4 分析 Analy

3、ticsA 4. 1 影响和地方法的开发/验证/确认 Impact on local method deve 1 opment/validation/verificationA. 4.2影响'"l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)A43影响批次整体考察Impact on batch overviewA. 4 4 影响方法传送 Impact on method transferA. 4. 5 影响免检 Impact on reduc

4、ed testingA. 4. 6 影响对照品 Impact on reference standardsA. 5 体系 System需要新的或更新稳定性研究New or update of stability study requiredA 6 物流 LogisticsA. 6. 1 影响"i地相关产品 Impact on locally related productsA & 2 需告知购买 / 配送 Need to inform Purchasing and/or suppliers and/or distributionA. 6 3 商提供质虽标准给供应商 Speci

5、fication needed be transferred to supplierA. 6. 4 需要新的或升级质量协议 New (or update) Quality AgreementA 6 5 斋要更改已处理的订单 Change applicable to orders already in progressA. 6. 6 影响库存 Impact on stockA. 6. 7 限制产品的配送 Restrictions to product distributionA. 8 法规 RegulatoryA & 1 与当地的法规文件符合性 Impact on local regul

6、atory specification documentsA&2需要在当地政府机关备案Need for local filingA. 8 3 等待批准后才实施 Implementation wait for approvalB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 PeopleB. 1. 1 实施培训 TrainingB 2 文件 DocumentsB. 2. 1 影响打地的内部标准文件 Impact

7、on local in-house specification documentsB 2 2 需要批准供应商所签署的标准文件 Approval sign off on specification documents by supplierB. 2. 3 变址包装形式 Change to packaging typeB 2 4 影响贮存条件 Impact on storage conditionsB25 影响取样 Impact on samplingB. 2. 6 需更新（通常的）交货条件 Update o（general） delivery conditionsB27影响合格供应商清单Impa

8、ct on approved vendor listB. 2. 8 影响包装匸艺 Impact on packaging instructionsB. 2.9影响、"l地法规中所描述的制造方法 Impact on manufacturing method description in local regulatoryFilesB3实验室设备Lab EquipmentB. 3. 1 需要新设备 New equipment neededB 2（新）设备需确认 / 校验（New） equipment to be qualified / calibratedB 4 分析 AnalyticsB

9、. 4. 1 影响检验方法 Impact on test methodB42与供户的方法进行比较Method comparison with supplierB 4 3 提供质量标准给供应商 Specification needed be transferred to supplierB44 影响免检 Impact on reduced testingB 4 5 需送小样进行检验 Samples need be supplied for testB. 4. 6 需合同实验室來检验 Contract lab involved for testingB5 体系 / 质量 System/Qualit

10、yB 5.1稳定性研尤 Impact on stability studies* 加速稳定性考察 Accelerated stability test* 长期稳定性考察 Long time stability testB 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Certificatestatus* IS09001 / IS011001 认证 IS09001 / IS014001 complianceB. 5. 3 影响产品效期 Impact shelf lifeB. 5 4 试机 Trial

11、runningB 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 runsB. 5. 6 影响包材设计 Impact on design of ArtworkB. 5. 7 供应商审计 Audit supplierB 5 8 特殊釋放 Need specific releaseB» 5. 9 试验(特征)批 Need trial batchesB. 5. 10影响供户的产品质虽证书Impact on CoA of supplierB6市场MarketsB. 6. 1 需要通知销售

12、部 Notification sale(s)B. 6. 2需要销售部批准Approval sale(s)B 7 物流 LogisticsB. 7. 1 涉及其他的生产场所/承包商 Involve other manufacturing sites / contractorsB.7.2 影响进程中的订单 Change applicable to orders already in progressB. 7. 3 影响库存 Impact on stockB. 8 法规 RegulatoryB & 1 与销售国法规冲突 Impact on marketing countries regula

13、tory requirementsB& 2需要在销售国政府机关备案Need for marketing countries filingB 8 3 需审批后执行 Implementation after approvalB & 6 影响残留溶剂/挥发性有机朵质 Impact on residual solvents / organic volatile impurities (OVI)C生产工艺Production ProcessesC. 1 概述 GeneralC. 1.1 进行培训 TrainingC 1.2文件 Update documents (weighing, fi

14、ling, manufacturing, packaging)*管理/操作程序Update procedures* 匸艺路线数据表 Routing Data Collection Form*工艺规程MPI* 批记录BPR Update Batch Production RecordC. 2 GMPC. 2. 1匸艺验证 Process Validation*验证方案Protocol*验证报告Report* 验证次数 Number of runs* 再验证(Re)"validationC. 2.2淸洁验证 Cleaning validation*验证方案protocol*验证报告Rep

15、ort* 验证次数 Number of runs* 再验证(Re)"validationC. 2. 3 稳定性研尤 Stability studies* 加速稳定性考察 Accelerated stability test* 长期稳定性考察 Long time stability testC. 2. 4 微生物评估 Microbiological assessmentC. 2.5 影响批址 Impact on the Batch SizeC. 2. 6 物料编码淸笊 Update material code listC. 2. 7 设备清单 Update equipment list

16、C.3 物流LogisticsC. 3.1 影响到相关产品 Affect related productsC 2 涉及到其他的生产地或合同方 Other manufacturing sites / contractors involvedC. 3. 3 升版或起草质:ft协议 Need to draft new (or update) Quality AgreementC S 4 限制产品配送 Restrictions to product distributionC5创建或改变物料/产品编码Create / changed material /product codesC. 3. 6 影响到

17、供应商 Impact on suppliersC. 4 法规 RegulatoryC. 4.1相关信息/支持文件备案Need for filing in SFDA/PFDAC 4 2 审批后执行 Implementation after approvalD设备/设施Equipment -Facilities - UtilitiesD1概述GeneralD. 1.1 实施培训 TrainingD 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 proc

18、edure* 维修 / 校验程序 Update Mamtenance/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* 平面图 Update lay-out drawing* 房间的洁净级另lj Update room classification plan* 相关电机或气动原理图 Update electrical - mecha

19、nical or pneumatic drawing* PID 图纸 Update of P&ID (process and instrumental diagram) required ?D. 2 GMPD. 2. 1需婆进彳亍确认Qualification* 验证主讣划 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 Projec

20、t 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 ReportD 2.2

21、更新预防维修计划 Update Preventive Maintenance plan (program)更新预防维修指南 / 清单 Update Preventive Maintenance instruction/ checklistJi!新校验汁划 Update calibration programJi!新校验记录 Update calibration records进行校验 Need CalibrationD. 2. 3 进行功能测试(方案/报告)Functionality test ( protocol /report)D. 24需要提供材料证明/精确度/完工证明Certifica

22、te for material, accuracy or finishingD25 设备标识 Labeling of equipmentD 2.6自动化(汁算机化)系统 Automated (computerized) systems* 计算机验证 Computer system validationD 2 7 环境监测(微生物.物理及化学)Impact on environmental monitoring (microbiology, physical, chemical)D28设备台帐日志New logbooksD 3 物流 LogisticsD. 3. 1 影响相关设备 Affect

23、related equipmentD. 8.2 需雯购买 / 供户 / 发货确认 Need to inform Purchasing and/or suppliers and/or distribution (=updatedescription of equipment parts )D 3 3 需要签署新的或更新质址协议 New (or update) Quality Agreement with contractorD 4 法规 RegulatoryD4l需要在销售国政府机关备案Need for marketing countries filingD. 4. 2 等待批准后才实施 Imp

24、lementation wait for approvalE环境、健康及安全EHSE. 1 安全 SafetyE. 1.1人员的安全 Risk for the safety of persons* 1：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，商热.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Bynoise, heat, pressure, radio-active ionizing radiation, nonion

25、izing radiation (eg laser), biological agents and vibrations* 危险或高活性物料(致癌物质.激素,OEL,. ) By hazardous materials (carcinogens,hormone, OEL,)* 电击 By electrocution* 静电 By static electricityE. 1.2设备的安全 Impact on the safety of equipment* 超过 / 低于压力 OverAmder pressure* 过fit灌装 Overfilling* 报警，互锁.控制及监视系统 Alarm

26、, interlock, control & monitoring system*设备是否有零进入的安全防护装宜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(process equipment, pipes, structure, floor) of equipment* 设备耐腐蚀(匸艺设备，管道等)Corrosion resistance (process equipment, pipes) of equipment* 兼容物料和生产设备 Compatibility of

27、 materia 1 s/production equipmentE 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，暴爲区域的识别.剩余风险的评估，方法的描述，安迓的顺序)The change have an impact on the risk identification & evaluation (= identification of danger, identification of those exposed

28、/target/risk area, assessment of rest risks, description of measures* 关健的安全系统 / 设备 / 元器件 Safety-critical system./equipment/component*爆炸的风险explosion risksE. 1.5需要被卜列部门/人员控制检査或评估Control, inspection or evaluation is needed by :* 安全部 Safety department* 1：业卫生人员(测虽噪音.光照，温度，化学物质)Industrial hygienist (measu

29、rement:noise, light, temperature, chemical substances, )* 业健康医师 Occupational health physician* 独立的权威的检査机构 Independent authorized inspection body (pressurizedequipment,)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

30、 on safety certificates of equipmentE. 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 animpact on safety instructions/procedures/company policies (operation /maintenance/emergency/start-up)E9是否带來人机匸程学风险The change introduce an ergonomic riskE. 1. 10是否会引入新的限制区 The change introduce confined spaces*

31、在限制区上方是否需要锚定点 Anchoring points are required above confined spacesE. 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 reduced to a minimum levelE. 1. 12对J亠区安全设施布迓图的影响Impact on site safety drawingsE. L 13影响消防(洒水牟，便携式灭火器)及紧急响应系统(火警.烟雾检测应急照明)Impacton Fire Protection (sprinklers, portable fi

32、re protection equipment) & Emergency Response (fire alarm, smoke detectors, emergency lighting,)E. 1. 14 影响地的泄漏程序及设备 Impact on the local spill procedure & equipmentE» 1.15 影响设备的标识 Impact on labeling of equipmentE. 2 环境 EnvironmentE. 2.1影响环境许可（控制物质，放射能，电离一非电离试剂麻醉品.）Impact on theenvironme

33、ntal permit(regulated substances, radioactivity, ionizing & nonionizmg agents, narcotics,)E.2.3影响地区的规划（植树，绿地）E. 2. 2 影响建筑物的许可证 Impact on the building permitImpact on the regional planning (planting, green space)E. 2.4影响对大气的扌IE放 Impact on air emissions in the atmosphere* 排放有机物 Emission of organic

34、 substances* 排放无机物 Emission of inorganic substances* 排放CO: Emission of CO:* 排放较低/较商的臭味 Emission of a lower/higher odor*使用对臭氧层造成危吿的物质(如氛利昂)？ Does the change involves the use of substances dangerous for ozone layer (eg Freon)?E. 2. 5 影响水的消耗 Impact on consumption of waterE 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 introductionE. 2