【正文】 2023/3/22023/3/22023/3/2Mar232Mar23 ? 1越是無(wú)能的人，越喜歡挑剔別人的錯(cuò)兒。 2023/3/22023/3/22023/3/22023/3/23/2/2023 ? 1他鄉(xiāng)生白發(fā)，舊國(guó)見(jiàn)青山。 ? Implement GA for the renovated systems. 對(duì)改造的系統(tǒng)進(jìn)行偏差分析。 ? Due to lack of specialized CQ people, most of the CQ jobs rely on subcontractors or vendors, the jobs’ quality is not under control, and the owner or the EPC contractor has to pay extra charges for each equipment or system. 由于缺乏專(zhuān)業(yè)的調(diào)試與確認(rèn)人員，大部分的調(diào)試與確認(rèn)工作依賴(lài)于分包商或供應(yīng)商，工作質(zhì)量不可控，而業(yè)主或總承包商不得不為每一設(shè)備或系統(tǒng)付出額外的費(fèi)用。CHINA ANNUAL CONFERENCE 16th – 17th April 2023, Beijing Commissioning Qualification Services Integrated into the Pharmaceutical Project Lifecycle 與制藥工程項(xiàng)目全過(guò)程相整合的調(diào)試與確認(rèn)服務(wù) Presented by Lu, Haorong 盧浩榮 Reviewed by Henk Man Agenda 議程 ? Introduction 導(dǎo)言 ? Definition and Contents Of ICQ Service ICQ服務(wù)的定義與內(nèi)容 ? Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方 ? Necessity必要性 ? Implementation 實(shí)施 ? References and Acknowledgements 參考文獻(xiàn)與致謝 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導(dǎo)言 ? Concepts 概念 Good Engineering Practice良好工程規(guī)范 Established engineering methods and standards that are applied throughout the project lifecycle to deliver appropriated costeffective ， 以交付合理的 、 經(jīng)濟(jì)有效的解決方案 。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導(dǎo)言 ? Current Issues Relative to CQ in Chinese Pharmaceutical Industry （ cont.） 當(dāng)前中國(guó)醫(yī)藥工業(yè)中調(diào)試與確認(rèn)的相關(guān)問(wèn)題 （續(xù)） ? Though several QV consultants available, the scope and standards of works are undetermined, and therefore both quantity and quality of their works are hard to evaluate. 盡 管有數(shù)家確認(rèn)與驗(yàn)證咨詢(xún)服務(wù)提供商，但工作范圍與標(biāo)準(zhǔn)不明確，因而工作的數(shù)量與質(zhì)量都很難評(píng)估。 ? Develop the schematic design of WFI system (. MB, PFD， main equipment list) in the BOD of the facility （ design consultant). 在設(shè)施的設(shè)計(jì)基礎(chǔ)中進(jìn)行 注射用水系統(tǒng)的方案設(shè)計(jì)（物料平衡、工藝流程圖 ,主要設(shè)備表等） (設(shè)計(jì)咨詢(xún)方）。 2023年 3月 2日星期四 2023/3/22023/3/22023/3/2 ? 1比不了得就不比，得不到的就不要。 2023/3/22023/3/22023/3/2Thursday, March 2, 2023 ? 1知人者智，自知者明。 2023/3/22023/3/22023/3/23/2/2023 2:23:49 PM ? 1越是沒(méi)有本領(lǐng)的就越加自命不凡。 2023/3/22023/3/22023/3/2Thursday, March 2, 2023 ? 1乍見(jiàn)翻疑夢(mèng)，相悲各問(wèn)年。 ?Relationship of ASTM Standard to GMP regulations and guidance documents ASTM標(biāo)準(zhǔn)與 GMP法規(guī)和指南文件的關(guān)系 日本 美國(guó) 歐盟 諸如 CFR “設(shè)備應(yīng)按書(shū)面程序進(jìn)行校驗(yàn)、檢查、或核對(duì)以確保其恰當(dāng)性能”等條款是確認(rèn)的基礎(chǔ) ICH Q9 質(zhì)量風(fēng)險(xiǎn)管理可用來(lái)決定“確認(rèn)”的范圍 指導(dǎo)如何執(zhí)行 ASTM標(biāo)準(zhǔn)的主要原理及基本原則 闡明基于風(fēng)險(xiǎn)的查證（或確認(rèn)）的原理及基本原則 ? Benefits to the Owner 為業(yè)主帶來(lái)的好處 ? Risk controlled earlier 風(fēng)險(xiǎn)及早得到控制 ? Reduce time and cost to achieve and maintain pliance 降低項(xiàng)目完成所耗費(fèi)用與時(shí)間并維持項(xiàng)目的合規(guī)性 ? Reduce change orders during construction 減少施工過(guò)程的變更令 ? Less waste repetition 更少的浪費(fèi)與重復(fù) ? Reduce project delays 較少項(xiàng)目推遲 ? Shorten building turnover period 縮短建筑交付周期 ? Validation team and QMS set up 建立驗(yàn)證團(tuán)隊(duì)和質(zhì)量管理體系 ? Earlier released and mercial manufacture 更早地通過(guò)認(rèn)證并投入商業(yè)生產(chǎn) Necessity必要性 ? Benefits to the Owner (cont.) 為業(yè)主帶來(lái)的好處 (續(xù)） ? Cost effective operation and maintenance 經(jīng)濟(jì)高效的運(yùn)行及維護(hù) ? Reduce equipment replacement 減少設(shè)備更換 ? Better knowledge, understanding of systems 對(duì)系統(tǒng)更好的認(rèn)識(shí)和理解 ? Better trained operations staff 更好地培訓(xùn)運(yùn)行團(tuán)隊(duì) ? Operations and maintenance manuals are plete and submitted at project turnover. 運(yùn)行及維護(hù)手冊(cè)完成并在項(xiàng)目交付時(shí)提交 Necessity必要性 ? Benefits to the Contractors對(duì)承包商的好處 ? Better planning will result in improved installation 更好的計(jì)劃可導(dǎo)致安裝的改進(jìn) ? More emphasis on quality control on what matters 對(duì)質(zhì)量控制更加強(qiáng)調(diào) ? Quicker resolution of problems (identify problems during QC) 更快地解決問(wèn)題（在 QC過(guò)程中界定問(wèn)題） ? Increase likelihood of pleting project on schedule – maximize profit 提高按時(shí)完成項(xiàng)目的可能性 — 利潤(rùn)最大化 ? Reduce postconstruction callbacks – preserve profit 減少施工后召回 — 保護(hù)利潤(rùn) Necessity必要性 ? Benefits to the Authorities 對(duì)監(jiān)管部門(mén)的好處 ? Genuine ,valid and systemic documentations 文件真實(shí)、有效、系統(tǒng) ? Easy of inspection 便于檢查 ? Genuine, credible records and trends 真實(shí)可信的記錄與趨勢(shì) ? Easy of supervision 便于監(jiān)管 ? Clear management programs, integral approvals in manufacturer’s site 廠商管理程序清晰，審批完整 ? Easy of investigation afterwards便于事后追究 Necessity必要性 Implementation Flow of Pharmaceutical Project 制藥工業(yè)項(xiàng)目實(shí)施流程 Production Start 有效投產(chǎn) Feasibility Study 可行性研究 Concept Design 概念設(shè)計(jì) Procurement 采購(gòu) Construction 施工 Detail Engineering 詳細(xì)設(shè)計(jì) Support Validation 驗(yàn)證支持 CQ 調(diào)試與 確認(rèn) Decision “GO” 客戶(hù)決定工 程繼續(xù)進(jìn)行 Basic + Ext. Basic Engineering 基本＋擴(kuò)充設(shè)計(jì) Final investment Decision 客戶(hù)做出最 終投資決定 Cost Estimate 造價(jià) 估算 ? 20% Cost Estimate 造價(jià) 估算 ? 10% Concept Phase 概念階段 Design Phase 設(shè)計(jì)階段 Execution Phase 實(shí)施階段 Hand Over 交付 Validation Phase 驗(yàn)證階段 Maintenance Customer Service 維修 /客戶(hù)服務(wù) Facility Management 設(shè)施管理 Second Opinion Value Engineering 修改 /補(bǔ)充 Implementation 實(shí)施 ? Workflow 工作流程 Acknowledgement （感謝） : Instruction from Mr. D .W. Vincent F(設(shè)施 )URS GA偏差分析 BOD設(shè)計(jì)基礎(chǔ) VMP驗(yàn)證總計(jì)劃 RA風(fēng)險(xiǎn)分析 E/S(設(shè)備 /系統(tǒng) )URS VP驗(yàn)證計(jì)劃 CSV FD/FS功能設(shè)計(jì) /說(shuō)明 DD/DS詳細(xì)設(shè)計(jì) /設(shè)計(jì)說(shuō)明 CP(FAT, SAT, etc.), 調(diào)試計(jì)劃及確認(rèn)方案 PQ性能確認(rèn) OQ運(yùn)行確認(rèn) IQ安裝確認(rèn) Commissioning (FAT/SAT, etc.) Exec.調(diào)試（工廠 /現(xiàn)場(chǎng)驗(yàn)收測(cè)試等）執(zhí)行 DQ設(shè)計(jì)確認(rèn) Procurement Construction采購(gòu)施工 CV清潔驗(yàn)證 Sterilization Validation 滅菌驗(yàn)證 PV工藝驗(yàn)證 Medium Fill 培養(yǎng)基灌裝 Utility Qua/Val 公用系統(tǒng)確認(rèn) /驗(yàn)證 Fumigation Validation 熏蒸驗(yàn)證 AIQ分析儀器確認(rèn) CSV 計(jì)算機(jī)系統(tǒng)驗(yàn)證 CSV 計(jì)算機(jī)系統(tǒng)驗(yàn)證 CSV 計(jì)算機(jī)系統(tǒng)驗(yàn)證