【文章內容簡介】 Contents (cont.) 服務內容（續(xù)） ? Develops Cx contract language for the A/E Construction contracts 編制建筑 /工程設計及施工合同中的調試條款 ? Guides the Development Quality System Program and Implementation Plan 指導編制質量體系程序及實施方案 ? Guides the total CQ process 指導調試、確認全過程 ? Ensures implementation of selected measures identified in the OPR 確保業(yè)主項目需求中明確的選擇措施的實施 ? Verifies minimum targets have been met 查證最低目標已滿足 ? Completes final CQ report 完成最終調試、確認報告 Definition and Contents of ICQ Services ICQ服務的定義與內容 2023 ISPE CHINA ANNUAL CONFERENCE ? Contents (cont.) 服務內容（續(xù)） ? Guides Computer System Validation指導計算機系統(tǒng)驗證 ? Guides Analytical Instrument Qualification and Analytical Method Analysis指導分析儀器確認與分析方法驗證 ? Guides Cleaning, Sterilization, and Fumigation Validation指導清潔、滅菌、熏蒸驗證 ? Guides the PV process, pletes PV report 指導工藝驗證過程，完成工藝驗證報告 ? Coordinates system testing and operator training 協(xié)調系統(tǒng)測試和操作人員培訓 Definition and Contents of ICQ Services ICQ服務的定義與內容 2023 ISPE CHINA ANNUAL CONFERENCE ? Service Packets Breakdown 服務工作包分解 ?Gap analysis and URS development guidance偏差分析及設施用戶需求編制指導 ?GMP review GMP審核 ?System Impact Assessment and Validation Master Plan development 系統(tǒng)影響評估與驗證總計劃編制 ?Quality system program and implementation plan development Guidance 質量體系程序及實施方案編制指導 Definition and Contents of ICQ Services ICQ服務的定義與內容 2023 ISPE CHINA ANNUAL CONFERENCE ? Service Packets Breakdown (cont.) 服務工作包分解 （續(xù)） ?Risk Analysis and SE/URS SOP, VP development guidance 風險分析及設備 /系統(tǒng)用戶需求、驗證計劃編制指導 ?Commissioning Plan and Qualification Protocol development guidance調試 計劃和確認方案編制指導 ?Component Impact Assessment, Risk Assessment guidance and DQ 組件影響分析、風險分析指導與設計確認 ?IQ， OP， PQ guidance安裝確認、運行確認、性能確認指導 ?Computer System Validation guidance計算機系統(tǒng)驗證指導 Definition and Contents of ICQ Services ICQ服務的定義與內容 2023 ISPE CHINA ANNUAL CONFERENCE ? Service Packets Breakdown (cont.) 服務工作包分解 （續(xù)） ?Analytical Instrument Qualification and Analytical Method Validation Guide分析儀器確認與分析方法驗證指導 ?Cleaning, Sterilization, and Fumigation Validation guide 清潔、滅菌、熏蒸驗證指導 ?Process Validation guide工藝驗證指導 Definition and Contents of ICQ Services ICQ服務的定義與內容 2023 ISPE CHINA ANNUAL CONFERENCE Services Provider and Stakeholders 服務提供商及相關方 ?The Qualified Service Team Structure 合格的服務團隊人員構成 ?Based on the project scope, resource requirements, and the key stakeholders。 取決于項目的范圍、資源需求以及主要相關方 。 ?Experienced and professional in individual field。 在相應領域具有經驗和專業(yè)素養(yǎng) ?Need to understand the roles, responsibilities, and levels of authority。 應能理解自身的角色、責任以及權力層次； ?Have excellent munication, planning, and coordination between different 、計劃與協(xié)調。 2023 ISPE CHINA ANNUAL CONFERENCE Services Provider and Stakeholders 服務提供商及相關方 ?The Qualified Service Team Structure (cont.) 合格的服務團隊人員構成（續(xù)） ?Including but not limited to, 包括但不限于， ?Team leader 團隊領導 ?Compliance and regulatory expert 合規(guī)和法規(guī)專家 ?Mechanical CQ engineer (HVAC, utilities) 機械調試與確認工程師（暖通、公用） ?Process equipment/system CQ engineer 工藝設備、工藝系統(tǒng)調試與確認工程師 2023 ISPE CHINA ANNUAL CONFERENCE Services Provider and Stakeholders 服務提供商及相關方 ?The Qualified Service Team Structure (cont.) 合格的服務團隊人員構成（續(xù)） ?Computer system validation engineer (software and hardware) 計算機系統(tǒng)驗證工程師 ?AMV engineer and process validation engineer 分析方法驗證工程師及工藝驗證工程師 ?Cleaning， sterilization, and fumigation validation engineer 清潔，滅菌，熏蒸驗證工程師 ?Document coordinator and technical writer 文件協(xié)調控制員及技術文件編制人員 2023 ISPE CHINA ANNUAL CONFERENCE Services Provider and Stakeholders 服務提供商及相關方 ?The Qualified Service Team Structure (cont.) 合格的服務團隊人員構成（續(xù)） ?Outsource support subject matter experts of pliance and regulatory, mechanical (HVAC, utilities), process equipment, clean finishing, operation, QC/QA, QMS etc. 合規(guī)和法規(guī)、機械（暖通、公用）、工藝與設備、潔凈裝修、運行、質量控制與質量保證、質量管理體系等外部學科問題支持專家。 2023 ISPE CHINA ANNUAL CONFERENCE ?Other Project Parties 其它項目參與方 ? A/E consultants 工程設計 ?Procurement 采購 ?Construction 施工 ?Project management 項目管理 ?Commissioning leaders or coordinator from contractors and owner 承包商、業(yè)主調試負責人或協(xié)調員 ?Operations/Production, maintenance, RD, EHS, QC, QA, Qualification Validation from the owner 業(yè)主生產運行、維護、研發(fā)、環(huán)保及健康安全、 QC、QA、確認與驗證等部門 Services Provider and Stakeholders 服務提供商及相關方 2023 ISPE CHINA ANNUAL CONFERENCE ?The Authorities 監(jiān)管部門 ?Food Drug Administration食品藥品監(jiān)督部門 ?Municipal planning construction administration規(guī)劃、建設管理部門 ?Environmental Protection環(huán)保部門 ?Fire authority消防部門 ?Safety Supervision Administration安全監(jiān)督部門 ?Labor Protection 勞動保護部門 ?Quality Supervision 質量監(jiān)督部門 Services Provider and Stakeholders 服務提供商及相關方 2023 ISPE CHINA ANNUAL CONFERENCE ?Regulatory Requirements 法規(guī)要求 Necessity必要性 Source（來源） : R. E. Chew and D. Petko (2023)