【正文】 有數(shù)家確認(rèn)與驗證咨詢服務(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)量都很難評估。 ? Due to absence of SME in some disciplines , the QV consultants sometimes can only reveal the defects in the project, but fail to present the costeffective solutions for them, especially when the GMP conflicts with local codes, . fire fighting or EHS codes. 由于某些專業(yè)的專家欠缺，確認(rèn)與驗證咨詢服務(wù)提供商有時僅能揭示項目的某些缺陷，但不能給出相應(yīng)的經(jīng)濟(jì)有效的解決方案，尤其是在 GMP與國內(nèi)規(guī)范，如消防、環(huán)保、職業(yè)安全衛(wèi)生規(guī)范發(fā)生沖突時。 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(jī)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(kuò)展到項目交付 、 直到運行和維護(hù)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 ?Definition (cont.)定義（續(xù)） When Does Commissioning Occur? 調(diào)試的時機(jī) Commissioning can begin during predesign, design, construction or building startup. The process can offer significantly greater and more cost effective benefits when it begins during predesign or early design. 調(diào)試可從設(shè)計前 、 設(shè)計 、 施工或開車的時候開始 。 當(dāng)從設(shè)計前或者設(shè)計早期開始時， 該過程能產(chǎn)生更大并更經(jīng)濟(jì)有效的效益 。 Commissioning integration into qualification調(diào)試與確認(rèn)的整合 Commissioning can support qualification if performed within a qualification regime. In this case, it is critical to define the overall scope of the tests and verifications to be performed for a system, before starting any missioning or qualification work. 當(dāng)按確認(rèn)的制度來進(jìn)行時 ， 調(diào)試可用以支持確認(rèn) ， 關(guān)鍵是在開展調(diào)試與確認(rèn)工作前 ， 應(yīng)定義系統(tǒng)測試與查證的所有范圍 。 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(hù) 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 – Multiple Trial Runs to Get Things Right 多次試運行以達(dá)標(biāo) – IQ, OQ, PQ and Acceptance Criteria IQ,OQ, PQ及接受標(biāo)準(zhǔn) – GEP scope and QA scope overlapped GEP和 QA范圍重疊 – Focused on Documentation Deliverables 注重關(guān)注文件 – Rigid Change Management剛性的變更管理 ASTM E2500 – Design Inputs設(shè)計輸入 – Design Review設(shè)計審核 – Risk Mitigation降低風(fēng)險 – Critical Control Parameters Define Acceptance Criteria 關(guān)鍵控制參數(shù)定義接受標(biāo)準(zhǔn) – Verification Testing確認(rèn)測試 – Performance Testing 性能測試 – GEP scope and QA scope have clear boundary GEP和 QA界限清晰 – Process, Product Quality and Patient Safety工藝，產(chǎn)品質(zhì)量和病人安全 – Quality by Design, Design Space and Continuous Improvement質(zhì)量源于設(shè)計，設(shè)計空間及持續(xù)改進(jìn) Definition and Contents of ICQ Services ICQ服務(wù)的定義與內(nèi)容 ?Definition (cont.)定義（續(xù)） Source（來源） : IT Pharma Validation Europe (2023) 2023 ISPE CHINA ANNUAL CONFERENCE ? Contents服務(wù)內(nèi)容 ? Represents ―owner ― as an objective advocate 作為目標(biāo)宣傳者代表業(yè)主 ? Guides the development of FURS, URS 指導(dǎo)編制設(shè)施 URS及系統(tǒng) URS ? Organizes or attends gap analysis, impact assessment, risk assessment and DR or DQ組織或參加偏差分析、影響分析、風(fēng)險評估以及設(shè)計審核或設(shè)計確認(rèn) ? Reviews standards/strategies early in design 在設(shè)計階段審核標(biāo)準(zhǔn) /策略 ? Develops the Cx Plan and VMP編制調(diào)試計劃及驗證總計劃 Definition and Contents of ICQ Services ICQ服務(wù)的定義與內(nèi)容 2023 ISPE CHINA ANNUAL CONFERENCE ?