【正文】 ect parties led to considerable overlapping or missing of project works, missioning integration with qualification is rare. 不同項目參與方節(jié)點不清，溝通不暢導(dǎo)致相當(dāng)?shù)捻椖抗ぷ髦丿B或漏項 , 罕有調(diào)試與確認(rèn)進行整合。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導(dǎo)言 ? Gap to Current Good Practices of the International Pharmaceutical Industry 與當(dāng)前國際醫(yī)藥工業(yè)良好實踐的差距 Aspects 方面 China 中國 International 國際 Marketing Environment 市場環(huán)境 Obvious demand, limited investment, development required 需求明顯但投入有限，需要培育 Regular demand, worth to invest, mature and normative 需求一般，認(rèn)為投入值得，成熟、規(guī)范 Professionals 專業(yè)人員 Limited quantity, inexperienced, disciplineabsent 數(shù)量、經(jīng)驗有限，學(xué)科配套不齊全 Abundant, experienced, plete disciplines， high cost 數(shù)量充足，經(jīng)驗豐富，學(xué)科齊全 ,費用昂貴 Organization 機構(gòu) Temporal, project based, lately involve 臨時、基于項目、后期介入 Standing, multiprojects, lifecycle involved 常設(shè)，多項目，全程 Implementation 執(zhí)行 Random, no strict procedure, absent or overlapping隨意，無嚴(yán)格程序，漏項或重疊 Normative, strict procedure, integrity 規(guī)范、程序嚴(yán)格、過程完整 Documentation 文件 Poor integrity , irregular, nonrealtime， reference absent 完整性差，不規(guī)范，非實時，引用失缺 Good integrity, normative, realtime, plete reference, credible 完整性好，規(guī)范，實時，引用齊全可信 Approach 方法 Partly follows ISPE Baseline Guide 5 僅部分參照 ISPE調(diào)試與確認(rèn)指南 ASTM E2500 07+ISPE Baseline Guide + GAMP5 2023 ISPE CHINA ANNUAL CONFERENCE ? Definition 定義 Commissioning qualification services integrated into the pharmaceutical project lifecycle（ ICQ Services) are the valuable consulting services provided by a professional CQ consultant to help owner or EPC contractor to implement the missioning and qualifications of design, installation, operation, performance of facilities, systems, and equipments, and finally the process validation of the facilities of a pharmaceutical project by applying GEP, GMP principles and engineering experiences， beginning with developing the OPR and extending through all phases of project delivery and into operation and maintenance. 與制藥工程項目全過程相整合的調(diào)試與確認(rèn)服務(wù) (ICQ服務(wù) ） 系由專業(yè)調(diào)試與確認(rèn)咨詢商提供有價值的咨詢服務(wù) ， 應(yīng)用 GEP、 GMP原則和工程經(jīng)驗 ， 從形成業(yè)主項目需求開始擴展到項目交付 、 直到運行和維護等所有階段 ， 提供有價值的咨詢服務(wù) ， 幫助業(yè)主或總承包商完成制藥工程項目中設(shè)施 、 系統(tǒng) 、 設(shè)備的調(diào)試以及設(shè)計 、 安裝 、 運行 、 性能等一系列確認(rèn)乃至設(shè)施的工藝驗證等 。 Definition and Contents of ICQ Services ICQ服務(wù)的定義與內(nèi)容 PreDesign Design Construction StartUp Operations Maintenance Test Balance Startup Testing ? Definition (cont.)Commissioning Span of Control 定義 (續(xù) )調(diào)試跨度的控制 Commissioning 設(shè)計前 調(diào)試 開車測試 設(shè)計 施工 開車 運行及維護 測試及平衡 Source（來源） : D. Colburn et al. (2023) ICQ CQ 15 Risk Management 風(fēng)險 管理 Design Review 設(shè)計審 核 Change Management 變 更管理 Good Engineering Practice良好工程 規(guī) 范 ASTM E250007: Standards for Specification, Design Verification of Pharmaceutical Biopharmaceutical Manufacturing Systems Equipment ? Definition (cont.)Flexible Approach ASTM E2500 定義 (續(xù) )ASTM E2500 07柔性方法 16 ISPE Baseline Guide 5 – Design Inputs設(shè)計輸入 – Impact Assessment 影響評估 – Design Qualification 設(shè)計確認(rèn) – Commissioning 調(diào)試 在相應(yīng)領(lǐng)域具有經(jīng)驗和專業(yè)素養(yǎng) ?Need to understand the roles, responsibilities, and levels of authority。 ?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 歐盟 諸如 CFR “設(shè)備應(yīng)按書面程序進行校驗、檢查、或核對以確保其恰當(dāng)性能”等條款是確認(rèn)的基礎(chǔ) ICH Q9 質(zhì)量風(fēng)險管理可用來決定“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)主帶來的好處 ? Risk controlled earlier 風(fēng)險及早得到控制 ? Reduce time and cost to achieve and maintain pliance 降低項目完成所耗費用與時間并維持項目的合規(guī)性 ? Reduce change orders during construction 減少施工過程的變更令 ? Less waste repetition 更少的浪費與重復(fù) ? Reduce project delays 較少項目推遲 ? Shorten building turnover period 縮短建筑交付周期 ? Validation team and QMS set up 建立驗證團隊和質(zhì)量管理體系 ? Earlier released and mercial manufacture 更早地通過認(rèn)證并投入商業(yè)生產(chǎn) Necessity必要性 ? Benefits to the Owner (cont.) 為業(yè)主帶來的好處 (續(xù)） ? Cost effective operation and maintenance 經(jīng)濟高效的運行及維護 ? Reduce equipment replacement 減少設(shè)備更換 ? Better knowledge, understanding of systems 對系統(tǒng)更好的認(rèn)識和理解 ? Better trained operations staff 更好地培訓(xùn)運行團隊 ? Operations and maintenance manuals are plete and submitted at project turnover. 運行及維護手冊完成并在項目交付時提交 Necessity必要性 ? Benefits to the Contractors對承包商的好處 ? Better planning will result in improved installation 更好的計劃可導(dǎo)致安裝的改進 ? More emphasis on quality control on what matters 對質(zhì)量控制更加強調(diào) ? Quicker resolution of problems (identify problems during QC) 更快地解決問題（在 QC過程中界定問題） ? Increase likelihood of pleting project on schedule – maximize profit 提高按時完成項目的可能性 — 利潤最大化 ? Reduce postconstruction callbacks – preserve profit 減少施工后召回 — 保護利潤 Necessity必要性 ? Benefits to the Authorities 對監(jiān)管部門的好處 ? Genuine ,valid and systemic documentations 文件真實、有效、系統(tǒng) ? Easy of inspection 便于檢查 ? Genuine, credible records and trends 真實可信的記錄與趨勢 ? 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)項目實施流程 Production Start 有效投產(chǎn) Feasibility Study 可行性研究 Concept Design 概念設(shè)計 Procurement 采購 Construction 施工 Detail Engineering 詳細(xì)設(shè)計 Support Validation 驗證支持 CQ 調(diào)