【正文】 CHINA ANNUAL CONFERENCE 16th – 17th April 2023, Beijing Commissioning Qualification Services Integrated into the Pharmaceutical Project Lifecycle 與制藥工程項目全過程相整合的調(diào)試與確認服務 Presented by Lu, Haorong 盧浩榮 Reviewed by Henk Man Agenda 議程 ? Introduction 導言 ? Definition and Contents Of ICQ Service ICQ服務的定義與內(nèi)容 ? Services Provider and Stakeholders 服務提供商及相關方 ? Necessity必要性 ? Implementation 實施 ? References and Acknowledgements 參考文獻與致謝 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? 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)濟有效的解決方案 。 Commissioning調(diào)試 A well planned, documented and managed engineering approach to the startup and turnover of facilities, systems, and equipment to the EndUser that results in a safe and function environment that meets established design requirements and stakeholder 一套良好計劃的 、 有文件記錄并受管理的工程方法 ， 對工程設施 、 系統(tǒng)和設備進行試車并交付最終用戶 ， 以建立符合既定設計要求及股東期望的安全 、 功能良好的環(huán)境 。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Concepts (cont.)概念（續(xù)） DQ設計確認 The documented verification that engineering design of a facility, utility or equipment that can affect product quality adhere to approved User Requirement and design specifications. 對可能影響產(chǎn)品質(zhì)量的設施 、 公用工程和設備的工程設計進行有文件記錄的查證 ， 確認與被批準的用戶需求和設計描述一致 。 IQ安裝確認 The documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications and are correctly installed. 對設施 、 公用工程和設備所有可能影響產(chǎn)品質(zhì)量的方面進行有文件記錄的查證 ， 確認與被批準的描述一致并已得到正確的安裝 。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Concepts (cont.)概念（續(xù)） OQ操作確認 The documented verification that all aspects of a facility, utility, or equipment that can affect product quality operate as intended throughout all anticipated ranges. 對設施 、 公用工程和設備所有可能影響產(chǎn)品質(zhì)量的方面進行有文件記錄的查證 ， 確認它們在預期的操作極限內(nèi)運行正確 。 PQ性能確認 The documented verification that all aspects of facility, utility, or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria. 對設施 、 公用工程和設備所有可能影響產(chǎn)品質(zhì)量的方面進行有文件記錄的查證 ， 確認其性能符合預先確定的驗收標準 。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Concepts (cont.)概念（續(xù)） PV工藝驗證 The process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. 建立文件證據(jù) ， 高度保證在特定生產(chǎn)工藝條件下 ， 可均一地生產(chǎn)符合預定標準和質(zhì)量屬性的產(chǎn)品的過程 。 More concepts 更多的概念 ? Risk Based – Commensurate with risk 基于風險 —與風險相適應 ? Science Based – CQA, CPPs 基于科學 —關鍵質(zhì)量屬性 、 關鍵工藝參數(shù) ? Quality by Design – Verify throughout 質(zhì)量源于設計 —全過程的驗證 ? Subject Matter Expert – Defined Role 學科問題專家 —角色定義 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Current Issues Relative to CQ in Chinese Pharmaceutical Industry 當 前中國醫(yī)藥工業(yè)中調(diào)試與確認的相關問題 ? Limited resource and focus on DQ and QBD is not well acknowledged. 投入資源有限，對設計確認、質(zhì)量源于設計等的重點未充分認識。 ? Very rare professional CQ consultants aligned with international standard and practice. 專業(yè)的、與國際標準、規(guī)范接軌的調(diào)試與確認咨詢服務提供商非常罕見。 ? Lack of local presence of international CQ consulting expertise and the corresponding local professional engineer supportive team. 國際知名調(diào)試與確認專家罕有常駐中國本地，同時缺乏與其配套的本地專業(yè)工程師支持團隊。 ? Importance of establishing a real QMS based on good CQ practices is not well acknowledged by endorser top management. 以良好的調(diào)試與確認實踐為基礎建立一個真正的質(zhì)量管理體系的重要性并未被企業(yè)高層管理人員充分認識。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Current Issues Relative to CQ in Chinese Pharmaceutical Industry （ cont.） 當前中國醫(yī)藥工業(yè)中調(diào)試與確認的相關問題 （續(xù)） ? Seldom correct applications of risk assessment approach and overinterpreting of GMP regulations without understanding their rationales led to overinvestment of the project. 風險分析方法罕有正確應用，未能從基本原理上進行理解，若干 GMP法規(guī)被過度解讀導致項目過度投資。 ? Seldom systematic planning at the very beginning, most are crash jobs in the final phase of the project. 鮮有在項目開始即進行系統(tǒng)性的策劃，大部分在項目后期進行突擊。 ? Frequent change orders due to issues exposed in the final CQ phase led to significant cost of remedy and delay. 因最終調(diào)試與確認階段暴露的問題而產(chǎn)生的變更導致可觀的索賠及工期延誤 。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Current Issues Relative to CQ in Chinese Pharmaceutical Industry （ cont.） 當前中國醫(yī)藥工業(yè)中調(diào)試與確認的相關問題 （續(xù)） ? Unclear interfaces and poor munications of the different project 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，溝通不暢導致相當?shù)捻椖抗ぷ髦丿B或漏項 , 罕有調(diào)試與確認進行整合。 ? 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. 由于缺乏專業(yè)的調(diào)試與確認人員，大部分的調(diào)試與確認工作依賴于分包商或供應商，工作質(zhì)量不可控，而業(yè)主或總承包商不得不為每一設備或系統(tǒng)付出額外的費用。 2023 ISPE CHINA ANNUAL CONFERENCE Introduction 導言 ? Current Issues Relative to CQ in Chinese Pharmaceutical Industry （ cont.） 當前中國醫(yī)藥工業(yè)中調(diào)試與確認的相關問題 （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