变更评估项目表

1、变更评估项目表项目号评估项目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 assessm

2、ent 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

3、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 (versusa.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

4、.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

5、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 wa

6、it for approval b 合同方供应商物料（原料, 包材 , 成品）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.2.4影响贮存条件impact on storage condi

7、tions 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

8、/ 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 testi

9、ng b.5 体系 /质量systemquality 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 iso9001iso14001 compliance b.5.3影响产品效期impact shelf

10、 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 supplierb.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

11、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 regulato

12、ry 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c.1 概述 general c.1.1进行培训training c.1.2文件 update documents (weighing, filing, manufacturing, packagin

13、g) * 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 r

14、uns * 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

15、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

16、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 d 设备设施d.1 概述 general d.1.1实施培训 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

17、 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 (process and instrum

18、ental diagram) required ? d.2 gmp d.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

19、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更新预防维修计划update preventive maintenance plan (program) 更新预防维修指南清单u

20、pdate 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 calibration d.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 finishing d.2.5设备标识labeling of equipment

21、 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环境监测（微生物，物理及化学）impact on environmental monitoring (microbiology, physical, d.2.8设备台帐日志new logbooks d.3 物流 logistics d.3.1影响相关设备affect related equipment d.3.2需要购买供户发货确认need to inform purchasing and/or suppliers a

22、nd/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

23、 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 pr

24、essure * 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/produc

25、tion 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 :

26、 * 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 a

27、n 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

28、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（控制物质，放射能，电离非电离试剂，麻醉

29、品，.) impact on the e.2.2影响建筑物的许可证impact on the building permit e.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

30、* 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 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