GMP項(xiàng)目驗(yàn)證管理和質(zhì)量管理課件

1、Engineering Validation Management for Pharmaceutical Project 制藥工程項(xiàng)目驗(yàn)證管理徐文勤 Engineering Validation ManagemIndex目錄Validation Mode 常見(jiàn)的驗(yàn)證模式Validation Cooperation 驗(yàn)證各相關(guān)方的協(xié)作Key Validation Activities 各階段的主要驗(yàn)證活動(dòng)Index目錄Validation Mode 常見(jiàn)的驗(yàn)證模PQ性能確認(rèn)PQ Test Plan測(cè)試計(jì)劃URS 用戶需求OQ Test Plan測(cè)試計(jì)劃OQ運(yùn)行確認(rèn)IQ安裝確認(rèn)IQ Test Pl

2、an測(cè)試計(jì)劃 Implement執(zhí)行Detail Design詳細(xì)設(shè)計(jì)Function Design 功能設(shè)計(jì)Validation Mode -ISPE “V” Mode常見(jiàn)的驗(yàn)證模式-ISPE “V”型確認(rèn)模式PQPQ Test Plan測(cè)試計(jì)劃URS OQ TestValidation Mode- ASTM E2500 Mode常見(jiàn)的驗(yàn)證模式-ASTM E2500 模式用戶需求需求文件需求鑒別關(guān)鍵系統(tǒng)測(cè)試完工報(bào)告影響因素評(píng)估調(diào)試IOQ項(xiàng)目調(diào)試計(jì)劃完工IOQ報(bào)告確認(rèn)測(cè)試確認(rèn)矩陣設(shè)計(jì)復(fù)核系統(tǒng)接受報(bào)告放行設(shè)計(jì)基礎(chǔ)僅注重產(chǎn)品/工藝/法規(guī)/項(xiàng)目質(zhì)量戰(zhàn)略要求用戶和其他要求的工程文件（如EHS)各系統(tǒng)應(yīng)

3、有單獨(dú)完工報(bào)告測(cè)試是單一的GEP活動(dòng)包括調(diào)試，SAT/FAT/IOQ確認(rèn)質(zhì)量戰(zhàn)略：基于需求文件的科學(xué)/風(fēng)險(xiǎn)導(dǎo)向流程及設(shè)計(jì)復(fù)核Validation Mode- ASTM E2500 MoValidation Mode- ASTM E2500 Mode常見(jiàn)的驗(yàn)證模式-ASTM E2500 模式URSRequirement DocumentRequirementsIdentification of Critical AspectsTestingClose-out ReportsImpact AssessmentCommissioningIOQPCQPClose-outIOQReportVerific

4、ation TestingVQS Matrix &Design ReviewSystem Acceptance & release reportDesign BasisFocused on product/process and regulatory/ PQS requirements onlyEngineering Document for user and other requirements (i.e.EHS)Single close-out report for systemTesting is a single GEP activity- covering Commissioning

5、, SAT/FAT/IOQVerification Quality Strategy: Science/Risk based approach based on requirement document and design reviewValidation Mode- ASTM E2500 MoValidation Cooperation驗(yàn)證各相關(guān)方的協(xié)作Owners Responsibilities 業(yè)主方的工作重點(diǎn)Build Validation management system based on GMP quality system 建立基于GMP質(zhì)量管理體系框架的驗(yàn)證管理體系Pro

6、ject flexibility study and issue URS 評(píng)估項(xiàng)目的可行性并出具用戶需求文件Impact Assessment, include process and system 影響因素評(píng)估,包括工藝及系統(tǒng)Prepare Validation Master Plan (VMP) 驗(yàn)證主計(jì)劃的制定Involve in qualification activities, from DQ to OQ 從設(shè)計(jì)確認(rèn)到運(yùn)行確認(rèn)的全過(guò)程參與PQ activities 性能確認(rèn)活動(dòng)Supplemented Validation Activities, such as PV,CV,CSV

7、后續(xù)的驗(yàn)證活動(dòng)，如工藝驗(yàn)證、清潔驗(yàn)證、計(jì)算機(jī)驗(yàn)證Validation Cooperation驗(yàn)證各相關(guān)方的Validation Cooperation驗(yàn)證各相關(guān)方的協(xié)作Contractors Responsibilities 項(xiàng)目總承包方的工作重點(diǎn)Build Validation management system based on Project QMS 建立基于項(xiàng)目質(zhì)量管理體系的驗(yàn)證管理體系Prepare Specification based on owners URS 根據(jù)業(yè)主的用戶需求 準(zhǔn)備規(guī)格說(shuō)明書(shū) Impact Assessment, include process and sy

8、stem 影響因素評(píng)估,包括工藝及系統(tǒng)Prepare Project Qualification Master Plan align with owners VMP 根據(jù)驗(yàn)證主計(jì)劃（VMP）準(zhǔn)備項(xiàng)目確認(rèn)主計(jì)劃（PQMP）Vendor evaluation (validation execution capability) 供應(yīng)商評(píng)估（驗(yàn)證活動(dòng)的執(zhí)行能力）DQ for Critical systems and process equipments 重要設(shè)施及重要工藝設(shè)備的設(shè)計(jì)確認(rèn)（DQ）Risk Analysis 風(fēng)險(xiǎn)分析IOQ for Critical systems and process

9、equipments 重要設(shè)施及重要工藝設(shè)備的安裝、運(yùn)行確認(rèn)（IOQ）FAT/SAT/CommissioningValidation Cooperation驗(yàn)證各相關(guān)方的Validation Cooperation驗(yàn)證各相關(guān)方的協(xié)作System/equipment vendors responsibilities 設(shè)備/系統(tǒng)供應(yīng)商的工作重點(diǎn)Prepare and execute FAT/SAT/Commissioning Plans 完善出廠接受測(cè)試、現(xiàn)場(chǎng)接受測(cè)試、調(diào)試計(jì)劃并執(zhí)行Participate in IOQ activities and prepare document 參與安裝運(yùn)行確

10、認(rèn)活動(dòng)，并準(zhǔn)備相關(guān)的文檔Prepare draft operational procedures for equipment and system 起草設(shè)備/系統(tǒng)相關(guān)操作規(guī)程草案Support PQ activities 支持性能確認(rèn)活動(dòng)Validation Cooperation驗(yàn)證各相關(guān)方的Validation Cooperation驗(yàn)證各相關(guān)方的協(xié)作獨(dú)立測(cè)試機(jī)構(gòu)及咨詢機(jī)構(gòu)提供具有權(quán)威性的測(cè)試計(jì)劃及測(cè)試數(shù)據(jù)支持PQ支持工藝自控系統(tǒng)的確認(rèn)提供各類后續(xù)的驗(yàn)證支持，如PV、CV、CSVValidation Cooperation驗(yàn)證各相關(guān)方的Key Validation Activities_

11、CD Phase各階段的主要驗(yàn)證活動(dòng)_概念設(shè)計(jì)階段GMP設(shè)計(jì)審核對(duì)概念設(shè)計(jì)階段的提交文件進(jìn)行符合性審核，由于此階段信息的粗略性，審核主要包括以下內(nèi)容：用戶需求總綱性描述文件工廠整體布局工藝流程圖及工藝總體描述文件自控系統(tǒng)的概念性描述文件Key Validation Activities_ CD Key Validation Activities_ CD Phase各階段的主要驗(yàn)證活動(dòng)_概念設(shè)計(jì)階段Validation Strategy 驗(yàn)證策略Main contents 主要內(nèi)容Regulatory requirement 法規(guī)依從性的要求Training and qualification

12、for design / execution team對(duì)設(shè)計(jì)/操作人員資質(zhì)及培訓(xùn)的要求Validation sequence 對(duì)驗(yàn)證序列的要求Validation documentation 驗(yàn)證的文件化要求Change Control and Deviation Management變更/偏差的處理Key Validation Activities_ CD Key Validation Activities_ BD Phase各階段的主要驗(yàn)證活動(dòng)_初步設(shè)計(jì)階段GMP設(shè)計(jì)審核對(duì)初步設(shè)計(jì)階段的提交文件進(jìn)行符合性審核，審核主要包括以下內(nèi)容：用戶需求(URS)各類設(shè)計(jì)規(guī)格描述(DS)及功能描述（FD

13、S)管線儀表圖潔凈分區(qū)圖Key Validation Activities_ BD Key Validation Activities_ BD Phase各階段的主要驗(yàn)證活動(dòng)_初步設(shè)計(jì)階段Impact Assessment 影響因素評(píng)估System Impact Assessment 系統(tǒng)影響因素Process impact Assessment 工藝影響因素Key Validation Activities_ BD Key Validation Activities_ BD Phase各階段的主要驗(yàn)證活動(dòng)_初步設(shè)計(jì)階段Validation Master Plan & Master Quali

14、fication Plan驗(yàn)證主計(jì)劃及項(xiàng)目確認(rèn)主計(jì)劃VMP focus on 主要討論以下幾個(gè)方面的內(nèi)容：Define Validation Scope based on impact assessment 驗(yàn)證范圍的確定：基于影響因素評(píng)估結(jié)論Define Responsibility 驗(yàn)證各方職責(zé)的劃分 Define Validation Strategy: detailed from CD phase 驗(yàn)證策略的確定：CD階段的驗(yàn)證策略的深化Validation Sequence and rough schedule 驗(yàn)證的順序及大致的進(jìn)度Description of key proces

15、s and Technocal 關(guān)鍵工藝及技術(shù)的簡(jiǎn)要描述Description of key validation activities 各項(xiàng)驗(yàn)證活動(dòng)的大致描述MQP focus on qualification activities only 項(xiàng)目確認(rèn)主計(jì)劃描述確認(rèn)活動(dòng)中各方的活動(dòng)Key Validation Activities_ BD Key Validation Activities_ BD Phase各階段的主要驗(yàn)證活動(dòng)_初步設(shè)計(jì)階段質(zhì)量驗(yàn)證活動(dòng)各類驗(yàn)證相關(guān)規(guī)程的建立，如偏差/變更管理、培訓(xùn)規(guī)程、文件規(guī)范相關(guān)指導(dǎo)原則的導(dǎo)入：如設(shè)備/設(shè)施確認(rèn)原則、自控確認(rèn)原則、HVAC確認(rèn)原則供應(yīng)商的

16、預(yù)確認(rèn)Key Validation Activities_ BD Key Validation Activities_ DD Phase各階段的主要驗(yàn)證活動(dòng)_詳細(xì)設(shè)計(jì)階段GMP Design Review設(shè)計(jì)審核Compliance Review on Detail Design Deliverables, mainly includes: 對(duì)詳細(xì)設(shè)計(jì)階段的提交文件進(jìn)行符合性審核，審核主要包括以下內(nèi)容：Architecture Review ( include site master plan) 建筑審核 (包括工廠總體規(guī)劃)Electrical Review 電氣審核Process/Equi

17、pment Review(include P&ID) 工藝/設(shè)備審核 (包括管線儀表圖)Utilities Review 公用設(shè)施審核HVAC Review (include cleanroom) 空調(diào)系統(tǒng)審核 (包括潔凈分區(qū))此階段的GMP設(shè)計(jì)審核建議由權(quán)威機(jī)構(gòu)主導(dǎo)Key Validation Activities_ DD Key Validation Activities_ DD Phase各階段的主要驗(yàn)證活動(dòng)_詳細(xì)設(shè)計(jì)階段Design Qualification設(shè)計(jì)確認(rèn)Mainly focus on 設(shè)計(jì)確認(rèn)的主要內(nèi)容：Responsibility definition 參與確認(rèn)各方的職

18、責(zé)界定Define applicable qualification principle and procedure 適用于確認(rèn)的原則及規(guī)程System applicable checklist 基于系統(tǒng)的檢查表Compliance review on design input and output 設(shè)計(jì)輸入和輸出的符合性檢查Risk Analysis 風(fēng)險(xiǎn)分析Conclusion 結(jié)論Key Validation Activities_ DD Key Validation Activities_ DD Phase各階段的主要驗(yàn)證活動(dòng)_詳細(xì)設(shè)計(jì)階段質(zhì)量驗(yàn)證活動(dòng)各類驗(yàn)證相關(guān)規(guī)程的執(zhí)行階段性驗(yàn)證進(jìn)

19、度報(bào)告供應(yīng)商的選擇及管理Key Validation Activities_ DD Key Validation Activities_ C&Q Phase各階段的主要驗(yàn)證活動(dòng)_施工/調(diào)試/確認(rèn)階段FAT/SAT/CommissioningFAT/SAT/Commissioning is GEP activities, validation team mainly focus on 系純工程類活動(dòng)，驗(yàn)證團(tuán)隊(duì)的工作重點(diǎn)體現(xiàn)在以下幾個(gè)方面：Ensure Validation requirements have been considered in these plans 審核計(jì)劃的可實(shí)施性，確保驗(yàn)

20、證要求得到體現(xiàn)Execution personnel must be trained and qualified 實(shí)施人員的資質(zhì)應(yīng)符合驗(yàn)證要求Witness to avoid duplicate work 全程目擊此類活動(dòng)以避免重復(fù)性執(zhí)行Integrity文件記錄的真實(shí)性、有效性、完整性Key Validation Activities_ C&QKey Validation Activities_ C&Q Phase各階段的主要驗(yàn)證活動(dòng)_施工/調(diào)試/確認(rèn)階段Installation Qualification 安裝確認(rèn)IQ activities includes, but may not li

21、mits: 安裝結(jié)束后進(jìn)行，一般包括下列內(nèi)容：System identification and description 系統(tǒng)的描述和鑒定Define responsibility 確認(rèn)中各方職責(zé)的劃分As-built status check各類竣工狀態(tài)對(duì)于設(shè)計(jì)成果的符合性確認(rèn)Documentation 文件化的要求 Deviation Management 偏差的處理Final assessment 最終評(píng)估Attachments(as-built drawings, construction procedures, FAT report, material certificates, f

22、irst cleaning report, operation manual, training record, spare parts list) 附件 (包括竣工圖，施工相關(guān)標(biāo)準(zhǔn)文件，出廠測(cè)試報(bào)告，材質(zhì)證明，最后清潔的證明，操作手冊(cè)，培訓(xùn)記錄，備件清單等。）Key Validation Activities_ C&QKey Validation Activities_ C&Q Phase各階段的主要驗(yàn)證活動(dòng)_施工/調(diào)試/確認(rèn)階段Operational Qualification 運(yùn)行確認(rèn)System identification and description 系統(tǒng)的描述和鑒定Define responsibility 確認(rèn)中各方職責(zé)的劃分Compliance Test for system/equipment 和系統(tǒng)/設(shè)備相關(guān)的符合性測(cè)試Documentation 文件化的要求Deviation Management 偏差的處理Final assessment 最終評(píng)估Attachment(t