【干货】变更评估项目清单！

针对一系列的变更法规变化及企业亟待解决的变更难点，特设“变更管理”研修班。学习通道扫描右方二维码即刻报名本文汇总了变更评估过程中需要考虑的事项，供大家在评估变更时予以参考，建议将它附在变更评估流程或放在变更管理SOP，以便在评估变更时可以更好参考，避免遗漏：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PeopleA.1.1实施培训 TrainingA.2文件DocumentsA.2.1影响规程/内控标准 Impact on procedures  /in-house specificationA.2.2新质量标准的合理性说明 Justification  of 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 qualified / calibratedA.4分析AnalyticsA.4.1影响方法开发/验证/确认  Impact on local method development/validation/verificationA.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 (versusA.4.3影响批次整体考察 Impact  on batch overviewA.4.4影响方法转移 Impact  on method transferA.4.5影响免检 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试验 New or update of stability study requiredA.6其他LogisticsA.6.1影响当地相关产品 Impact  on locally related productsA.6.2需告知采购/供应/发运  Need to inform Purchasing and/or suppliers and/or  distributionA.6.3需提供质量标准给供应商 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影响法规文件符合性 Impact  on local regulatory specification documentsA.8.2需要备案 Need  for local filingA.8.3等待批准方可实施 Implementation  wait for approvalB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PeopleB.1.1实施培训 TrainingB.2文件DocumentsB.2.1影响企业标准文件 Impact  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 of(general) delivery conditionsB.2.7影响合格供应商清单 Impact  on approved vendor listB.2.8影响包装工艺 Impact  on packaging instructionsB.2.9影响当地法规所规定的制造方法 Impact on manufacturing method description in local regulatory FilesB.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影响分析方法 Impact  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System／QualityB.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 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  Certificate status* ISO9001／ISO14001 认证 ISO9001／ISO14001 complianceB.5.3影响产品效期 Impact  shelf lifeB.5.4试机 Trial  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特殊释放 Need  specific releaseB.5.9试验(特征）批 Need trial batchesB.5.10影响供应商的检验报告书 Impact  on CoA of supplierB.6市场MarketsB.6.1需要通知销售部 Notification  sale(s)B.6.2需要销售部批准 Approval  sale(s)B.7其他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与销售国的法规冲突 Impact  on marketing countries regulatory requirementsB.8.2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.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培训 TrainingC.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 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)-validationC.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 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其他LogisticsC.3.1影响到相关产品 Affect  related productsC.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需要备案 Need  for filing in FDAC.4.2审批后执行 Implementation  after approvalD  设备／设施Equipment -Facilities - UtilitiesD.1概述GeneralD.1.1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 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 GMPD.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 ReportD.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  CalibrationD.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 finishingD.2.5设备标识 Labeling  of equipmentD.2.6自动化（计算机化）系统 Automated  (computerized) systems* 计算机验证  Computer system validationD.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  logbooksD.3             其他LogisticsD.3.1影响相关设备 Affect  related equipmentD.3.2需要采购／供应商／发运确认 Need to inform Purchasing and/or suppliers and/or distribution (=  updateD.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 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 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 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 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 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:* 职业健康医师  Occupational health physician* 独立的权威的检查机构  Independent authorized inspection body (pressurizedE.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 anE.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 Process glass been eliminated orE.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）  ImpactE.1.14影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（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 permitE.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 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.2.8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 surroundingE.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 efficientE.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 independentE.2.16对当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 toE.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 and* 需要供给呼吸用的空气  Requirement for breathing air注：1、这不是一份详尽的清单，不能包含所有的变更评估项目，这亦不是一份适用所有情况的清单，用户应企业和变更的具体情况适当调整。