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)--盧浩榮

1、CHINA ANNUAL CONFERENCE 16th – 17th April 2012, 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),Presente

2、d by Lu, Haorong 盧浩榮Reviewed by Henk Man,Agenda議程,Introduction 導(dǎo)言Definition and Contents Of I-C&Q Service I-C&Q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

3、 and Acknowledgements 參考文獻(xiàn)與致謝,2012 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 lifecy

4、cle to deliver appropriated cost-effective solution.在項(xiàng)目周期中全程采用已建立的工程方法和標(biāo)準(zhǔn)，以交付合理的、經(jīng)濟(jì)有效的解決方案。Commissioning調(diào)試A well planned, documented and managed engineering approach to the start-up and turnover of facilities, systems

5、, and equipment to the End-User that results in a safe and function environment that meets established design requirements and stakeholder expectations.采用一套良好計(jì)劃的、有文件記錄并受管理的工程方法，對(duì)工程設(shè)施、系統(tǒng)和設(shè)備進(jìn)行試車并交付最終用戶，以建立符合既定設(shè)計(jì)要求及股東期望的安全、

6、功能良好的環(huán)境。,2012 ISPE CHINA ANNUAL CONFERENCE,Introduction 導(dǎo)言,Concepts (cont.)概念（續(xù)）DQ設(shè)計(jì)確認(rèn)The documented verification that engineering design of a facility, utility or equipment that can affect product quality adhere to ap

7、proved User Requirement and design specifications. 對(duì)可能影響產(chǎn)品質(zhì)量的設(shè)施、公用工程和設(shè)備的工程設(shè)計(jì)進(jìn)行有文件記錄的查證，確認(rèn)與被批準(zhǔn)的用戶需求和設(shè)計(jì)描述一致。IQ安裝確認(rèn) The documented verification that all aspects of a facility, utility or equipment that can affect product

8、 quality adhere to approved specifications and are correctly installed. 對(duì)設(shè)施、公用工程和設(shè)備所有可能影響產(chǎn)品質(zhì)量的方面進(jìn)行有文件記錄的查證，確認(rèn)與被批準(zhǔn)的描述一致并已得到正確的安裝。,2012 ISPE CHINA ANNUAL CONFERENCE,Introduction 導(dǎo)言,Concepts (cont.)概念（續(xù)）OQ操作確認(rèn)The document

9、ed verification that all aspects of a facility, utility, or equipment that can affect product quality operate as intended throughout all anticipated ranges. 對(duì)設(shè)施、公用工程和設(shè)備所有可能影響產(chǎn)品質(zhì)量的方面進(jìn)行有文件記錄的查證，確認(rèn)它們?cè)陬A(yù)期的操作極限內(nèi)運(yùn)行正確。PQ性能確認(rèn)T

10、he documented verification that all aspects of facility, utility, or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria. 對(duì)設(shè)施、公用工程和設(shè)備所有可能影響產(chǎn)品質(zhì)量的方面進(jìn)行有文件記錄的查證，確認(rèn)其性能符合預(yù)先確定

11、的驗(yàn)收標(biāo)準(zhǔn)。,2012 ISPE CHINA ANNUAL CONFERENCE,Introduction 導(dǎo)言,Concepts (cont.)概念（續(xù)）PV工藝驗(yàn)證The process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently pr

12、oduce a product meeting its pre-determined 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(yù)定標(biāo)準(zhǔn)和質(zhì)量屬性的產(chǎn)品的過(guò)程。More concepts 更多的概念Risk Based – Commensurate with risk 基于風(fēng)險(xiǎn)—與風(fēng)險(xiǎn)相適應(yīng)Science Based – CQA, C

13、PPs 基于科學(xué)—關(guān)鍵質(zhì)量屬性、關(guān)鍵工藝參數(shù)Quality by Design – Verify throughout 質(zhì)量源于設(shè)計(jì)—全過(guò)程的驗(yàn)證Subject Matter Expert – Defined Role 學(xué)科問(wèn)題專家—角色定義,2012 ISPE CHINA ANNUAL CONFERENCE,Introduction 導(dǎo)言,Current Issues Relative to C&Q in Chinese

14、 Pharmaceutical Industry 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Limited resource and focus on DQ and QBD is not well acknowledged. 投入資源有限，對(duì)設(shè)計(jì)確認(rèn)、質(zhì)量源于設(shè)計(jì)等的重點(diǎn)未充分認(rèn)識(shí)。Very rare professional C&Q consultants aligned with international standar

15、d and practice. 專業(yè)的、與國(guó)際標(biāo)準(zhǔn)、規(guī)范接軌的調(diào)試與確認(rèn)咨詢服務(wù)提供商非常罕見。Lack of local presence of international C&Q consulting expertise and the corresponding local professional engineer supportive team. 國(guó)際知名調(diào)試與確認(rèn)專家罕有常駐中國(guó)本地，同時(shí)缺乏與其配套的本地專業(yè)工

16、程師支持團(tuán)隊(duì)。Importance of establishing a real QMS based on good C&Q practices is not well acknowledged by endorser top management. 以良好的調(diào)試與確認(rèn)實(shí)踐為基礎(chǔ)建立一個(gè)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(rèn)識(shí)。,2012 ISPE CHINA ANNUAL CONFERENCE,Intro

17、duction 導(dǎo)言,Current Issues Relative to C&Q 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)）Seldom correct applications of risk assessment approach and over-interpreting of GMP regulations without u

18、nderstanding their rationales led to overinvestment of the project. 風(fēng)險(xiǎn)分析方法罕有正確應(yīng)用，未能從基本原理上進(jìn)行理解，若干GMP法規(guī)被過(guò)度解讀導(dǎo)致項(xiàng)目過(guò)度投資。Seldom systematic planning at the very beginning, most are crash jobs in the final phase of the project.

19、 鮮有在項(xiàng)目開始即進(jìn)行系統(tǒng)性的策劃，大部分在項(xiàng)目后期進(jìn)行突擊。Frequent change orders due to issues exposed in the final C&Q phase led to significant cost of remedy and delay. 因最終調(diào)試與確認(rèn)階段暴露的問(wèn)題而產(chǎn)生的變更導(dǎo)致可觀的索賠及工期延誤。,2012 ISPE CHINA ANNUAL CONFERENCE,In

20、troduction 導(dǎo)言,Current Issues Relative to C&Q 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)）Unclear interfaces and poor communications of the different project parties led to considerable overlap

21、ping or missing of project works, commissioning integration with qualification is rare. 不同項(xiàng)目參與方節(jié)點(diǎn)不清，溝通不暢導(dǎo)致相當(dāng)?shù)捻?xiàng)目工作重疊或漏項(xiàng), 罕有調(diào)試與確認(rèn)進(jìn)行整合。Due to lack of specialized C&Q people, most of the C&Q jobs rely on sub-contrac

22、tors 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(rèn)人員，大部分的調(diào)試與確認(rèn)工作依賴于分包商或供應(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

23、的費(fèi)用。,2012 ISPE CHINA ANNUAL CONFERENCE,Introduction 導(dǎo)言,Current Issues Relative to C&Q 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 Q&V consultants available, the scope an

24、d 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。 Due to absence of SME in some disciplines , the Q&V

25、consultants sometimes can only reveal the defects in the project, but fail to present the cost-effective solutions for them, especially when the GMP conflicts with local codes, e.g. fire fighting or EHS codes. 由于某些專業(yè)的專

26、家欠缺，確認(rèn)與驗(yàn)證咨詢服務(wù)提供商有時(shí)僅能揭示項(xiàng)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(guó)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(shí)。,2012 ISPE CHINA ANNUAL CONFERENCE,Introduction 導(dǎo)言,Gap to Current Good Practices of the International Pharmaceutical Industry 與當(dāng)前國(guó)際醫(yī)藥工業(yè)良好實(shí)

27、踐的差距,2012 ISPE CHINA ANNUAL CONFERENCE,Definition 定義Commissioning & qualification services integrated into the pharmaceutical project lifecycle（I-C&Q Services) are the valuable consulting services provided by a

28、professional C&Q consultant to help owner or EPC contractor to implement the commissioning and qualifications of design, installation, operation, performance of facilities, systems, and equipments, and finally the pr

29、ocess 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 o

30、peration and maintenance. 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)(I-C&Q服務(wù)）系由專業(yè)調(diào)試與確認(rèn)咨詢商提供有價(jià)值的咨詢服務(wù)，應(yīng)用GEP、GMP原則和工程經(jīng)驗(yàn)，從形成業(yè)主項(xiàng)目需求開始擴(kuò)展到項(xiàng)目交付、直到運(yùn)行和維護(hù)等所有階段，提供有價(jià)值的咨詢服務(wù)，幫助業(yè)主或總承包商完成制藥工程項(xiàng)目中設(shè)施、系統(tǒng)、設(shè)備的調(diào)試以及設(shè)計(jì)、安裝、運(yùn)行、性能等一系列確認(rèn)乃至設(shè)施的工藝驗(yàn)證等。,Definition and Co

31、ntents of I-C&Q Services I-C&Q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(shí)機(jī)Commissioning can begin during pre-design, design, construction or building start-up. The process can offer si

32、gnificantly greater and more cost effective benefits when it begins during pre-design or early design. 調(diào)試可從設(shè)計(jì)前、設(shè)計(jì)、施工或開車的時(shí)候開始。當(dāng)從設(shè)計(jì)前或者設(shè)計(jì)早期開始時(shí)，該過(guò)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Commis

33、sioning can support qualification if performed within a qualification regime. In this case, it is critical to define the over-all scope of the tests and verifications to be performed for a system, before starting any com

34、missioning or qualification work. 當(dāng)按確認(rèn)的制度來(lái)進(jìn)行時(shí)，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(cè)試與查證的所有范圍。,13,Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,,,,,,Pre-Design,Design,Construction,Start-Up,Operations &Ma

35、intenance,,,,,Test &Balance,,Start-up Testing,,,,Definition (cont.)--Commissioning Span of Control 定義(續(xù))--調(diào)試跨度的控制,Commissioning,設(shè)計(jì)前,調(diào)試,開車測(cè)試,設(shè)計(jì),施工,開車,運(yùn)行及維護(hù),測(cè)試及平衡,Source（來(lái)源）: D. Colburn et al. (2003),,I-C&Q,,C&

36、;Q,Risk Management 風(fēng)險(xiǎn)管理Design Review 設(shè)計(jì)審核Change Management 變更管理,Good Engineering Practice良好工程規(guī)范,ASTM E2500-07: Standards for Specification, Design & Verification of Pharmaceutical & Biopharmaceutical Manufactur

37、ing Systems & Equipment,Definition (cont.)--Flexible Approach ASTM E2500 定義(續(xù))--ASTM E2500 -07柔性方法,15,,,,,,ISPE Baseline Guide 5,– Design Inputs設(shè)計(jì)輸入 – Impact Assessment 影響評(píng)估– Design Qualification 設(shè)計(jì)確認(rèn)– Commission

38、ing 調(diào)試·– Multiple Trial Runs to Get Things Right 多次試運(yùn)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 Ch

39、ange Management剛性的變更管理,ASTM E2500,– Design Inputs設(shè)計(jì)輸入– Design Review設(shè)計(jì)審核 – Risk Mitigation降低風(fēng)險(xiǎn)– 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(cè)試 – Performance Testing 性能測(cè)

40、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(jì)，設(shè)計(jì)空間及持續(xù)改進(jìn),Definition and Contents of

41、 I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,Definition (cont.)定義（續(xù)）,Source（來(lái)源）:  IT Pharma Validation Europe (2008),16,,2012 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

42、表業(yè)主Guides the development of F-URS, URS 指導(dǎo)編制設(shè)施URS及系統(tǒng)URSOrganizes 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(xiǎn)評(píng)估以及設(shè)計(jì)審核或設(shè)計(jì)確認(rèn)Reviews standards/strategies early in design 在設(shè)計(jì)階

43、段審核標(biāo)準(zhǔn)/策略Develops the Cx Plan and VMP編制調(diào)試計(jì)劃及驗(yàn)證總計(jì)劃,Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,2012 ISPE CHINA ANNUAL CONFERENCE,Contents (cont.) 服務(wù)內(nèi)容（續(xù)）Develops Cx contract language for the A/E &

44、; Construction contracts 編制建筑/工程設(shè)計(jì)及施工合同中的調(diào)試條款Guides the Development Quality System Program and Implementation Plan 指導(dǎo)編制質(zhì)量體系程序及實(shí)施方案Guides the total C&Q process 指導(dǎo)調(diào)試、確認(rèn)全過(guò)程Ensures implementation of selected measures

45、 identified in the OPR 確保業(yè)主項(xiàng)目需求中明確的選擇措施的實(shí)施Verifies minimum targets have been met 查證最低目標(biāo)已滿足Completes final C&Q report 完成最終調(diào)試、確認(rèn)報(bào)告,Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,2012 ISPE CHINA ANNU

46、AL CONFERENCE,Contents (cont.) 服務(wù)內(nèi)容（續(xù)）Guides Computer System Validation指導(dǎo)計(jì)算機(jī)系統(tǒng)驗(yàn)證Guides Analytical Instrument Qualification and Analytical Method Analysis指導(dǎo)分析儀器確認(rèn)與分析方法驗(yàn)證 Guides Cleaning, Sterilization, and Fumigation V

47、alidation指導(dǎo)清潔、滅菌、熏蒸驗(yàn)證Guides the PV process, completes PV report 指導(dǎo)工藝驗(yàn)證過(guò)程，完成工藝驗(yàn)證報(bào)告Coordinates system testing and operator training 協(xié)調(diào)系統(tǒng)測(cè)試和操作人員培訓(xùn),Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,2012 ISPE

48、 CHINA ANNUAL CONFERENCE,,Service Packets Breakdown 服務(wù)工作包分解,Gap analysis and URS development guidance偏差分析及設(shè)施用戶需求編制指導(dǎo)GMP review GMP審核System Impact Assessment and Validation Master Plan development 系統(tǒng)影響評(píng)估與驗(yàn)證總計(jì)劃編制Quali

49、ty system program and implementation plan development Guidance 質(zhì)量體系程序及實(shí)施方案編制指導(dǎo),Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,2012 ISPE CHINA ANNUAL CONFERENCE,,Service Packets Breakdown (cont.) 服務(wù)工作

50、包分解 （續(xù)）,Risk Analysis and S-E/URS SOP, VP development guidance 風(fēng)險(xiǎn)分析及設(shè)備/系統(tǒng)用戶需求、驗(yàn)證計(jì)劃編制指導(dǎo)Commissioning Plan and Qualification Protocol development guidance調(diào)試計(jì)劃和確認(rèn)方案編制指導(dǎo)Component Impact Assessment, Risk Assessment guid

51、ance and DQ 組件影響分析、風(fēng)險(xiǎn)分析指導(dǎo)與設(shè)計(jì)確認(rèn)IQ，OP，PQ guidance安裝確認(rèn)、運(yùn)行確認(rèn)、性能確認(rèn)指導(dǎo)Computer System Validation guidance計(jì)算機(jī)系統(tǒng)驗(yàn)證指導(dǎo),Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,2012 ISPE CHINA ANNUAL CONFERENCE,,Service P

52、ackets Breakdown (cont.) 服務(wù)工作包分解 （續(xù)）,Analytical Instrument Qualification and Analytical Method Validation Guide分析儀器確認(rèn)與分析方法驗(yàn)證指導(dǎo)Cleaning, Sterilization, and Fumigation Validation guide 清潔、滅菌、熏蒸驗(yàn)證指導(dǎo)Process Validati

53、on guide工藝驗(yàn)證指導(dǎo),Definition and Contents of I-C&Q Services I-C&Q服務(wù)的定義與內(nèi)容,2012 ISPE CHINA ANNUAL CONFERENCE,,Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方,The Qualified Service Team Structure 合格的服務(wù)團(tuán)隊(duì)人員構(gòu)成Based o

54、n the project scope, resource requirements, and the key stakeholders; 取決于項(xiàng)目的范圍、資源需求以及主要相關(guān)方;Experienced and professional in individual field; 在相應(yīng)領(lǐng)域具有經(jīng)驗(yàn)和專業(yè)素養(yǎng)Need to understand the roles, responsibilities, and levels of a

55、uthority; 應(yīng)能理解自身的角色、責(zé)任以及權(quán)力層次；Have excellent communication, planning, and coordination between different parties.與不同的項(xiàng)目參與方間有很好的溝通、計(jì)劃與協(xié)調(diào)。,2012 ISPE CHINA ANNUAL CONFERENCE,,Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方,Th

56、e Qualified Service Team Structure (cont.) 合格的服務(wù)團(tuán)隊(duì)人員構(gòu)成（續(xù)）Including but not limited to, 包括但不限于，Team leader 團(tuán)隊(duì)領(lǐng)導(dǎo)Compliance and regulatory expert 合規(guī)和法規(guī)專家Mechanical C&Q engineer (HVAC, utilities) 機(jī)械調(diào)試與確認(rèn)工程師（暖通、公

57、用）Process equipment/system C&Q engineer 工藝設(shè)備、工藝系統(tǒng)調(diào)試與確認(rèn)工程師,2012 ISPE CHINA ANNUAL CONFERENCE,,Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方,The Qualified Service Team Structure (cont.) 合格的服務(wù)團(tuán)隊(duì)人員構(gòu)成（續(xù)）Computer sy

58、stem validation engineer (software and hardware) 計(jì)算機(jī)系統(tǒng)驗(yàn)證工程師AMV engineer and process validation engineer 分析方法驗(yàn)證工程師及工藝驗(yàn)證工程師Cleaning，sterilization, and fumigation validation engineer 清潔，滅菌，熏蒸驗(yàn)證工程師Document coordinator

59、 and technical writer文件協(xié)調(diào)控制員及技術(shù)文件編制人員,2012 ISPE CHINA ANNUAL CONFERENCE,,Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方,The Qualified Service Team Structure (cont.) 合格的服務(wù)團(tuán)隊(duì)人員構(gòu)成（續(xù)）Outsource support subject matter expert

60、s of compliance and regulatory, mechanical (HVAC, utilities), process & equipment, clean finishing, operation, QC/QA, QMS etc. 合規(guī)和法規(guī)、機(jī)械（暖通、公用）、工藝與設(shè)備、潔凈裝修、運(yùn)行、質(zhì)量控制與質(zhì)量保證、質(zhì)量管理體系等外部學(xué)科問(wèn)題支持專家。,2012 ISPE CHINA ANNUAL CONFER

61、ENCE,,Other Project Parties 其它項(xiàng)目參與方 A/E consultants 工程設(shè)計(jì)Procurement 采購(gòu)Construction 施工Project management 項(xiàng)目管理Commissioning leaders or coordinator from contractors and owner 承包商、業(yè)主調(diào)試負(fù)責(zé)人或協(xié)調(diào)員 Operations/Production,

62、maintenance, R&D, EHS, QC, QA, Qualification &Validation from the owner 業(yè)主生產(chǎn)運(yùn)行、維護(hù)、研發(fā)、環(huán)保及健康安全、QC、QA、確認(rèn)與驗(yàn)證等部門,Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方,2012 ISPE CHINA ANNUAL CONFERENCE,,The Authorities 監(jiān)管部門Fo

63、od & Drug Administration食品藥品監(jiān)督部門 Municipal planning & construction administration規(guī)劃、建設(shè)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(dòng)保護(hù)部門Quality

64、Supervision 質(zhì)量監(jiān)督部門,Services Provider and Stakeholders 服務(wù)提供商及相關(guān)方,2012 ISPE CHINA ANNUAL CONFERENCE,,Regulatory Requirements 法規(guī)要求,Necessity必要性,Source（來(lái)源）: R. E. Chew and D. Petko (2007),EU GMP Annex 15 and SFDA GMP Chap.

65、 7 “Qualification and Validation” define the requirements. 歐盟GMP附錄15和中國(guó)GMP第七章“確認(rèn)與驗(yàn)證”有明確要求。Relationship of ASTM Standard to GMP regulations and guidance documentsASTM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 211.68 “設(shè)備應(yīng)按書面程序進(jìn)行校

66、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 compliance

67、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)

68、隊(duì)和質(zhì)量管理體系 Earlier released and commercial 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)

69、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 complete 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,Nece

70、ssity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 pro