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1、Commissioning 取决于项目的范围、资源需求以及主要相关方;Experienced and professional in individual field; 在相应领域具有经验和专业素养Need to understand the roles, responsibilities, and levels of authority; 应能理解自身的角色、责任以及权力层次；Have excellent communication, planning, and coordination between different parties.与不同的项目参与方间有很好的沟通、计划与协调。201
2、2 ISPE CHINA ANNUAL CONFERENCEServices Provider and Stakeholders 服务提供商及相关方 The Qualified Service Team Structure (cont.)合格的服务团队人员构成（续）Including but not limited to, 包括但不限于，pTeam leader 团队领导pCompliance and regulatory expert 合规和法规专家pMechanical C&Q engineer (HVAC, utilities) 机械调试与确认工程师（暖通、公用）pProcess equ
3、ipment/system C&Q engineer 工艺设备、工艺系统调试与确认工程师2012 ISPE CHINA ANNUAL CONFERENCEServices Provider and Stakeholders 服务提供商及相关方 The Qualified Service Team Structure (cont.)合格的服务团队人员构成（续）pComputer system validation engineer (software and hardware) 计算机系统验证工程师pAMV engineer and process validation engineer 分析方
4、法验证工程师及工艺验证工程师pCleaning，sterilization, and fumigation validation engineer 清洁，灭菌，熏蒸验证工程师pDocument coordinator and technical writer文件协调控制员及技术文件编制人员2012 ISPE CHINA ANNUAL CONFERENCEServices Provider and Stakeholders 服务提供商及相关方The Qualified Service Team Structure (cont.)合格的服务团队人员构成（续）pOutsource support s
5、ubject matter experts of compliance and regulatory, mechanical (HVAC, utilities), process & equipment, clean finishing, operation, QC/QA, QMS etc. 合规和法规、机械（暖通、公用）、工艺与设备、洁净装修、运行、质量控制与质量保证、质量管理体系等外部学科问题支持专家。2012 ISPE CHINA ANNUAL CONFERENCEOther Project Parties 其它项目参与方p A/E consultants 工程设计pProcuremen
6、t 采购pConstruction 施工pProject management 项目管理pCommissioning leaders or coordinator from contractors and owner 承包商、业主调试负责人或协调员 pOperations/Production, maintenance, R&D, EHS, QC, QA, Qualification &Validation from the owner 业主生产运行、维护、研发、环保及健康安全、QC、QA、确认与验证等部门Services Provider and Stakeholders 服务提供商及相关方
7、2012 ISPE CHINA ANNUAL CONFERENCEThe Authorities 监管部门pFood & Drug Administration食品药品监督部门 pMunicipal planning & construction administration规划、建设管理部门pEnvironmental Protection环保部门pFire authority消防部门pSafety Supervision Administration安全监督部门pLabor Protection 劳动保护部门pQuality Supervision 质量监督部门Services Provi
8、der and Stakeholders 服务提供商及相关方2012 ISPE CHINA ANNUAL CONFERENCERegulatory Requirements 法规要求Necessity必要性Source（来源）: R. E. Chew and D. Petko (2007)pEU GMP Annex 15 and SFDA GMP Chap. 7 “Qualification and Validation” define the requirements. 欧盟GMP附录15和中国GMP第七章“确认与验证”有明确要 求。pRelationship of ASTM Standar
9、d to GMP regulations and guidance documents ASTM标准与GMP法规和指南文件的关系日本美国欧盟诸如CFR 211.68 “设 备应按书面程序进行 校验、检查、或核对 以确保其恰当性能” 等条款是确认的基础ICH Q9 质量风险管理可用 来决定“确认”的范围指导如何执行ASTM标准的 主要原理及基本原则阐明基于风险的查证（或 确认）的原理及基本原则 Benefits to the Owner 为业主带来的好处Risk controlled earlier 风险及早得到控制Reduce time and cost to achieve and main
10、tain compliance 降低项目完成所耗费用与时间并维持项目的合规性Reduce change orders during construction 减少施工过程的变更令Less waste & repetition 更少的浪费与重复Reduce project delays 较少项目推迟Shorten building turnover period 缩短建筑交付周期Validation team and QMS set up 建立验证团队和质量管理体系 Earlier released and commercial manufacture 更早地通过认证并投入商业生产 Necess
11、ity必要性 Benefits to the Owner (cont.) 为业主带来的好处(续）Cost effective operation and maintenance 经济高效的运行及维护Reduce equipment replacement减少设备更换Better knowledge, understanding of systems对系统更好的认识和理解Better trained operations staff更好地培训运行团队Operations and maintenance manuals are complete and submitted at project t
12、urnover.运行及维护手册完成并在项目交付时提交Necessity必要性 Benefits to the Contractors对承包商的好处Better planning will result in improved installation更好的计划可导致安装的改进More emphasis on quality control on what matters 对质量 控制更加强调Quicker resolution of problems (identify problems during QC) 更快地解决问题（在QC过程中界定问题）Increase likelihood of
13、completing project on schedule maximize profit 提高按时完成项目的可能性利润最大化Reduce post-construction callbacks preserve profit 减少 施工后召回保护利润Necessity必要性 Benefits to the Authorities 对监管部门的好处Genuine ,valid and systemic documentations 文件真实、有效、系统Easy of inspection 便于检查Genuine, credible records and trends 真实可信的记录与趋势E
14、asy of supervision 便于监管Clear management programs, integral approvals in manufacturers site 厂商管理程序清晰，审批完整Easy of investigation afterwards便于事后追究Necessity必要性Implementation Flow of Pharmaceutical Project 制药工业项目实施流程Production Start 有效投产Feasibility Study 可行性研究Concept Design 概念设计Procurement 采购Construction施
15、工Detail Engineering 详细设计Support Validation 验证支持C&Q调试与确认Decision “GO” 客户决定工 程继续进行Basic + Ext. Basic Engineering 基本扩充设计Final investment Decision 客户做出最 终投资决定Cost Estimate 造价估算 20%Cost Estimate 造价估算 10%Concept Phase概念阶段Design Phase设计阶段Execution Phase实施阶段 Hand Over 交付Validation Phase 验证阶段Maintenance Cust
16、omer Service 维修/客户服务FacilityManagement 设施管理Second OpinionValue Engineering 修改/补充Implementation 实施 Workflow 工作流程Acknowledgement （感谢）: Instruction from Mr. D .W. VincentF(设施)-URSGA偏差分析BOD设计基础VMP验证总计划RA风险分析E/S(设备/系统)-URSVP验证计划CSVFD/FS功能设计/说明DD/DS详细设计/设计说明CP(FAT, SAT, etc.), Qual.Protocol 调试计划及确认方案PQ性能确认OQ运行确认IQ安装确认Commissioning (FAT/SAT, etc.) Exec. 调试（工厂/现场验收测试等）执行DQ设计确认Procurement& Construction采购施工CV清洁验证Sterilization V
