变更评估项目表.doc

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1、【精品文档】如有侵权，请联系网站删除，仅供学习与交流变更评估项目表.精品文档.项目号 评估项目Item No. 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.1.1 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 新质量标准的合理性说明 Justification o

2、f new specification(s)A.2.3 需微生物评估 Microbiological assessmentA.2.4 文件的传送接收 Impact on transfer documents received/sentA.2.5 影响取样原则和方案 Impact on sampling instructionsA.2.6 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 需要新设备 New equipmentA.3.2 (新)设备验证校验 (New) equipment to be q

3、ualified / calibratedA.4 分析 AnalyticsA.4.1 影响当地方法的开发/验证/确认 Impact on local method development/validation/verificationA.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 (versusregulatory / supplier method)A.4.3 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

4、响免检 Impact on reduced testingA.4.6 影响对照品 Impact on reference standardsA.5 体系 SystemA.5.1 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 影响当地相关产品 Impact on locally related productsA.6.2 需告知购买配送 Need to inform Purchasing and/or suppliers and/or distributionA.6.3 需提供质量标准给供应

5、商 Specification 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 需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.8.1 与当地的法规文件符合性 Impact on local regulator

6、y specification documentsA.8.2 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 影响当地的内部标准文件 Impact on local

7、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 变更包装形式 Change to packaging typeB.2.4 影响贮存条件 Impact on storage conditionsB.2.5 影响取样 Impact on samplingB.2.6 需更新（通常的）交货条件 Update o(general) delivery conditionsB.2.7 影响合格供应商清单 Impact on a

8、pproved vendor listB.2.8 影响包装工艺 Impact on packaging instructionsB.2.9影响当地法规中所描述的制造方法 Impact on manufacturing method description in local regulatoryFilesB.3 实验室设备 Lab EquipmentB.3.1 需要新设备 New equipment neededB.3.2 （新）设备需确认校验 (New) equipment to be qualified / calibratedB.4 分析 AnalyticsB.4.1 影响检验方法 Imp

9、act on test methodB.4.2 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 supplierB.4.4 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 需合同实验室来检验 Contract lab involved for testingB.5 体系/质量 SystemQualityB.5.1稳定性研究 Imp

10、act 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* ISO9001ISO14001 认证 ISO9001ISO14001 complianceB.5.3 影响产品效期 Impact shelf lifeB.5.4 试机 Trial runningB.5.5工艺验证 Impac

11、t 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 特殊释放 Need specific releaseB.5.9 试验(特征）批 Need trial batchesB.5.10 影响供户的产品质量证书 Impact on CoA of supplierB.6 市场 MarketsB.6.1 需要通知销售部 Notification sale(s)B.6.2

12、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.8.1 与销售国法规冲突 Impact on marketing countries regulatory requirementsB.8.2 需要在销售国政府机关备案 N

13、eed for marketing countries filingB.8.3 需审批后执行 Implementation after approvalB.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 ProcessesC.1 概述 GeneralC.1.1 进行培训 TrainingC.1.2文件 Update documents (weighing, filing, manufacturing, packaging)* 管理操作程序 Upd

14、ate procedures* 工艺路线数据表 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)-validationC.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)-valid

15、ationC.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 testC.2.4 微生物评估 Microbiological assessmentC.2.5 影响批量 Impact on the Batch SizeC.2.6 物料编码清单 Update material code listC.2.7 设备清单 Update equipment listC.3 物流LogisticsC.3.1 影响到相关产品 Affect related productsC

16、.3.2 涉及到其他的生产地或合同方 Other manufacturing sites / contractors involvedC.3.3 升版或起草质量协议 Need to draft new (or update) Quality AgreementC.3.4 限制产品配送 Restrictions to product distributionC.3.5 创建或改变物料产品编码 Create / changed material /product codesC.3.6 影响到供应商 Impact on suppliersC.4 法规 RegulatoryC.4.1 相关信息/支持文

17、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 - UtilitiesD.1 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 procedure* 维修校验程序 Update Maintenance/Calibration procedur

18、e* 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 (proce

19、ss and instrumental diagram) required ?D.2 GMPD.2.1需要进行确认Qualification* 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

20、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更新预防维修计划 Update Preventive Maintenance plan (program)更新预防维修指南清单 Update

21、 Preventive Maintenance instruction/ checklist更新校验计划 Update calibration program更新校验记录 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.2.4 需要提供材料证明/精确度/完工证明 Certificate for material, accuracy or finishingD.2.5 设备标识 Labeling of equipmentD.2.6自动

22、化（计算机化）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)D.2.8 设备台帐日志 New logbooksD.3 物流 LogisticsD.3.1 影响相关设备 Affect related equipmentD.3.2 需要购买供户发货确认 Need to inform Purchasing and/or supplie

23、rs and/or distribution (= updatedescription of equipment parts )D.3.3 需要签署新的或更新质量协议 New (or update) Quality Agreement with contractorD.4 法规 RegulatoryD.4.1 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 Implementation wait for approvalE 环境、健康及安全 EHSE.1 安全 SafetyE.1.1人员的安全 Risk for th

24、e 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Bynoise, heat, pressure, radio-active ionizing radiation, non-ionizing radiation (e.g. laser),biological agents and vibrations* 危险或高活性物料（致癌物质，

25、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 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 guar

26、ding* 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 （工艺设备，管道等） Corrosion resistance (process equipment, pipes) ofequipment* 兼容物料和生产设备 Compatibility of materials/production equipmentE.1.3 引入新的风险（对于操作和维修） Introduce a risk on accessib

27、ility（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） The change have an impact on the risk identification & evaluation ( =identification of danger, identification of those exposed/target/risk area, assessment of rest risks,description of measures* 关键的安全系统设备元器件 Safety

28、-critical system/equipment/component* 爆炸的风险 explosion risksE.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:noise, light, temperature, chemical substances,.)* 职业健康医师 Occupational health physician

29、* 独立的权威的检查机构 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 procedureE.1.7 是否影响设备的安全证明 The change have an impact 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 safe

30、ty instructions/procedures/company policies (operation /maintenance/emergency/start-up)E.1.9 是否带来人机工程学风险 The change introduce an ergonomic riskE.1.10是否会引入新的限制区 The change introduce confined spaces* 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 Proce

31、ss glass been eliminated orreduced to a minimum levelE.1.12 对厂区安全设施布置图的影响 Impact on site safety drawingsE.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） Impacton Fire Protection (sprinklers, portable fire protection equipment) & Emergency Response (firealarm, smoke detectors, emergency lighting,)E.1.14 影

32、响当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，电离非电离试剂，麻醉品，.) Impact on theenvironmental permit (regulated substances, radioactivity, ionizing & non-ionizing agents,narcotics,)E.2.2 影响建筑物的许可证 Impact on t

33、he building permitE.2.3 影响地区的规划(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

34、氧层造成危害的物质（如氟利昂）？ Does the change involves the use ofsubstances dangerous for ozone layer (e.g. 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.

35、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,asbestos)* 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

36、surroundingarea)E.2.10 对土壤的影响 Impact on soilE.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 efficientdesignE.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 independentauthorized inspection bodyE.2.16 对当

37、前的环境监测程序的影响 Impact on the current environmental monitoring programE.3 健康 HealthE.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 topersonnelE.3.2 对MSDS 的影响 Impact on the Material Safety Data Sheet database andE.3.3 使用不合法的化学品 Involve use of chemical substances that have not been codifiedE.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 anddecontamination of PPE* 需要供给呼吸用的空气 Requirement for breathing air