GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí)

1、Austar Promotes Industry Advancement GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) GAMP5 (Good Automated Manufacturing Practice) 良好自動(dòng)化生產(chǎn)實(shí)踐指南 A Risk Based Approach to Compliant GxP Computerised System 遵從GxP計(jì)算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險(xiǎn)管理方法 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Different Terminology不同的術(shù)語(yǔ) Computerised Systems計(jì)算機(jī)系統(tǒng) Automation Syst

2、ems自動(dòng)化系統(tǒng) Control Systems控制系統(tǒng) Control Equipment控制設(shè)備 Data Management systems 數(shù)據(jù)管理系統(tǒng) Computerised System: A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control 計(jì)算機(jī)系統(tǒng):系統(tǒng)中包括數(shù)據(jù)輸入，電子化處理和用于報(bào)告或自控的信息輸出 SFDA: Good Manufact

3、uring Practice for pharmaceutical products (Draft for comment) SFDA：藥品生產(chǎn)質(zhì)量管理規(guī)范（征求意見(jiàn)稿） GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Introduce 簡(jiǎn)介 GAMP5（ Good Automated Manufacturing Practice -Rev5） GAMP是由國(guó)際制藥工程協(xié)會(huì)（ISPE）主編的實(shí)踐指南。自90年代以來(lái)，不斷 改版的良好自動(dòng)化生產(chǎn)實(shí)踐指南被廣泛使用并得到國(guó)際監(jiān)管部門(mén)的公認(rèn)。它是 計(jì)算機(jī)化系統(tǒng)驗(yàn)證的指導(dǎo)方針。GAMP5是GAMP的第5版本。 計(jì)算機(jī)化系統(tǒng) 由硬件、軟件、網(wǎng)絡(luò)組件和可控的功能和

4、相關(guān)文件組成 軟件 硬件 固件 控制系統(tǒng) 操作規(guī)程與人 員 設(shè)備 受控的功能與流程 計(jì)算機(jī)化系統(tǒng) GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FDA (FoodandDrug Administration) TGA (TherapeuticGoods Administration) 治療產(chǎn)品管理局 (MedicinesandHealthcareProductsRegulatory Agency waspreviouslytheMCA)（藥品及保健產(chǎn) 品管理局前身為藥品監(jiān)督局） EMEA (EuropeanMedicines EvaluationAgency includesMHRAand equiv

5、alentsfromother EUcountries) (歐洲藥品管理局包括 MHRA英國(guó)藥管局和其它 歐盟國(guó)家的對(duì)等機(jī)構(gòu)) 食品與藥物監(jiān)督管理局 MCC(Medicine ControlCouncil) 藥品控制委員會(huì) -如不符合管理規(guī)定，任何人都有權(quán)拒絕。 MHRA NIHS (NationalInstituteofHealth Science)（國(guó)立環(huán)境健康科學(xué) 研究院） HCSC (HealthCanada Sante Canada)加拿 大衛(wèi)生部 SFDA (Chinese FDA中國(guó)的 FDA) Industry Regulators行業(yè)監(jiān)管機(jī)構(gòu) - Regulate to en

6、sure safety of drugs that any of us might take! -通過(guò)管理保證我們?nèi)魏稳硕伎赡苡玫降乃幤返陌踩?- All have the power to refuse imports if their regulations are not met. GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) US FDA Automated processes. When computers or automated data processing systems are used as part of production or the quality system, th

7、e manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. 自動(dòng)化過(guò)程。當(dāng)計(jì)算機(jī)或自動(dòng)數(shù)據(jù)處理系統(tǒng)做為生產(chǎn)或質(zhì) 量系統(tǒng)的一部分時(shí)，制造商需要驗(yàn)證計(jì)算機(jī)軟件系統(tǒng)是按 照預(yù)先設(shè)計(jì)使用的。所

8、有軟件變更在準(zhǔn)許使用前是可驗(yàn)證 的。這些驗(yàn)證的活動(dòng)和結(jié)果應(yīng)該被文檔記錄。 PART 820 QUALITY SYSTEM REGULATION 質(zhì)量系統(tǒng)規(guī)則第820部分 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) EMEA Validation: The extent of validation necessary will depend on a number of factors including the use to which the system is to be put, whether the validation is to be prospective or retrospect

9、ive and whether or not novel elements are incorporated. Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying. 驗(yàn)證：驗(yàn)證的范

10、圍基于一組包含應(yīng)用于系統(tǒng)的因素，無(wú)論驗(yàn)證是預(yù)見(jiàn) 性的還是回顧性的，無(wú)論有無(wú)新元素的使用。驗(yàn)證應(yīng)該被認(rèn)為是計(jì)算 機(jī)系統(tǒng)完整生命周期的部分。這個(gè)周期包括設(shè)計(jì)，規(guī)范，編程，測(cè) 試，調(diào)試，文檔，運(yùn)行，監(jiān)控和修改。 Commission Directive 3003/94/ECAnnex 11 Computerised system 3003/94/EC調(diào)試指令附錄11計(jì)算機(jī)系統(tǒng) GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) SFDA Where automated and monitoring systems are used for these applications they should be val

11、idated to ensure that critical process requirements are met. 使用自動(dòng)化和監(jiān)視系統(tǒng)的地方，應(yīng)該被驗(yàn)證以確保滿(mǎn)足關(guān)鍵過(guò)程要求 Good Manufacturing Practice for pharmaceutical products, Part II Annex (Draft for Comment) Chapter 12 Terminal Sterilisation: 藥品生產(chǎn)質(zhì)量管理規(guī)范第二部分附錄（征求意見(jiàn)稿）第12章最終滅菌 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Addition補(bǔ)充 第110條（第1次的是115條款）：使用

12、計(jì)算機(jī)化倉(cāng)儲(chǔ)管理的，應(yīng)有 相應(yīng)的操作規(guī)程防止因系統(tǒng)故障、停機(jī)等特殊情況而造成物料和產(chǎn)品 的混淆和差錯(cuò)。 第164條（第1次的是172條款）：如使用電子數(shù)據(jù)處理系統(tǒng)、照相 技術(shù)或其它可靠方式記錄數(shù)據(jù)資料，應(yīng)有所用系統(tǒng)的詳細(xì)規(guī)程；記錄 的準(zhǔn)確性應(yīng)經(jīng)過(guò)核對(duì)。如果使用電子數(shù)據(jù)處理系統(tǒng)，只有受權(quán)人員方 可通過(guò)計(jì)算機(jī)輸入或更改數(shù)據(jù)，更改和刪除情況應(yīng)有記錄；應(yīng)使用密 碼或其它方式來(lái)限制數(shù)據(jù)系統(tǒng)的登錄；關(guān)鍵數(shù)據(jù)輸入后，應(yīng)由他人獨(dú) 立進(jìn)行復(fù)核。用電子方法保存的批記錄，應(yīng)采用磁帶、縮微膠卷、紙 質(zhì)副本或其它方法進(jìn)行備份，以確保記錄的安全，且數(shù)據(jù)資料在保存 期內(nèi)應(yīng)便于查閱。 來(lái)源：sFDA藥品生產(chǎn)質(zhì)量管理規(guī)范送審版

13、 第2次 2009.12.10 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Purpose 目的 Cost effective framework of good practice to ensure that computerised systems are fit for the intended use and compliant applicable regulations 良好實(shí)踐的有效架構(gòu)以保證計(jì)算機(jī)系統(tǒng)是滿(mǎn)足使用要求和 順從規(guī)章要求的 Safeguard: Patient safety, products quality, temperatureofprocessing; ambien

14、thumidity/temperature;cleanlinessofequipment 原材料的純度；工藝溫度；環(huán)境溫濕度；設(shè)備的潔凈度 d)Investigatethedesignspaceforeachattribute/parameterinorderto ratetheircriticality.對(duì)每項(xiàng)屬性/參數(shù)的設(shè)計(jì)空間進(jìn)行研究以判定其關(guān)鍵性 e.g.Howmuchcanambienthumidity/temperaturevarywithoutaffecting thetabletstability? 例如，在不影響片劑穩(wěn)定性的情況下環(huán)境溫濕度的允許變化范圍是多少？ GAMP5

15、KEY CONCEPTS 1- product/Process Understanding GAMP5 關(guān)鍵概念-對(duì)產(chǎn)品/工藝的理解 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) EnduserSHOULDdothefollowing:最終用戶(hù)應(yīng)： e)Usedthatinformationtoproposeacontrolstrategyforthe process.通過(guò)這種信息來(lái)提出工藝的控制策略。 e.g.ControlStrategyforAmbientT/RH?例如，環(huán)境溫濕度的控 制策略？ GAMP5 KEY CONCEPTS 1- product/Process Understandin

16、g GAMP5 關(guān)鍵概念-對(duì)產(chǎn)品/工藝的理解 f)CreateaURSsplittingthatcontrolstrategyintoindividual functions(relatedtoCPPs andclassifiedaccordingtotheirimpact). 編寫(xiě)URS，將這種控制策略分配到單獨(dú)的控制功能中（與工藝參數(shù) 相關(guān)并根據(jù)其影響進(jìn)行分類(lèi)）。 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Planning cover: 計(jì)劃包含 activities, Responsibility, procedures temperature of processing; cleanlin

17、ess of equipment). 確定可能會(huì)影響任何關(guān)鍵質(zhì)量屬性（例如純度可能會(huì)受輸入 原料的純度、工藝溫度、設(shè)備潔凈度等影響）的材料屬性和工藝參數(shù) Identify the Design Space for those material attributes and process parameters (ie determine how they can vary whilst still giving good quality product) in order to determine which are Critical Material Attributes or Critic

18、al Process Parameters (CPPs) and to give each an impact rating確定這些物料屬性和工藝參數(shù)的設(shè)計(jì)空間（即確定在保證良好產(chǎn)品質(zhì) 量的同時(shí)其所允許的變化范圍）以確定哪些是關(guān)鍵質(zhì)量屬性或關(guān)鍵工藝參數(shù)并對(duì)其進(jìn)行影 響性評(píng)定 Use that information to propose a control strategy for the process which will guarantee operation within the design space and also guarantee that any necessary da

19、ta to prove this is collected. 使用該信息為將保證操作在設(shè)計(jì)空間范圍內(nèi)并保證收集了證明這一點(diǎn)的數(shù) 據(jù)的流程而提出的控制策略 Create a URS which splits the control strategy into individual functions (related to critical process parameters) and classified according to their impact on product quality / patient safety / data integrity. 編制URS將該控制策略分為各

20、單獨(dú)的功能（與關(guān)鍵工藝參數(shù)相關(guān)） 并根據(jù)其對(duì)產(chǎn)品質(zhì)量/患者安全性/數(shù)據(jù)完整性的影響將其分類(lèi)。 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Risk Assessment風(fēng)險(xiǎn)評(píng)估 Risk Assessment report details the risk assessment and mitigation process throughout the project lifecycle. 風(fēng)險(xiǎn)評(píng)估報(bào)告詳細(xì)描述了整個(gè)項(xiàng)目周期中風(fēng)險(xiǎn)評(píng)定和 Risk Assessment is the responsibility of the user, supported by supplier 風(fēng)險(xiǎn)評(píng)估是用戶(hù)的責(zé)

21、任，受供應(yīng)商的支持 Risk Assessment is a continuous process and must be carried out at various stages during system life cycle 風(fēng)險(xiǎn)評(píng)估是一個(gè)連續(xù)的過(guò)程，在系統(tǒng)生命周期的不同 階段都要執(zhí)行 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) RA- Contents 風(fēng)險(xiǎn)評(píng)估-內(nèi)容 Relationship to other Documents與其它文件的關(guān)系 Applicable standard適用標(biāo)準(zhǔn) Relationship to customer User Requirements Speci

22、fication與客戶(hù)用戶(hù)需求說(shuō)明之間關(guān)系 Project overview項(xiàng)目概述 Summary of Process to be controlled所需控制工藝概述 Relevant GxP regulations相關(guān)GxP法規(guī) Project boundaries and interfaces (scope of supply and validation項(xiàng)目范圍和界面（供貨范圍和驗(yàn)證） System Architecture系統(tǒng)結(jié)構(gòu) System classification: Hardware and software categories系統(tǒng)分類(lèi)：硬件和軟件類(lèi)別 GAMP5及計(jì)

23、算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Probabilityofafailure? 故障可能性？ Delectabilityofa failure? 故障可檢測(cè)性？ Howriskmanaged? 風(fēng)險(xiǎn)如何控制 進(jìn)行功能性風(fēng)險(xiǎn)評(píng)估并確定控制模式 實(shí)施并確認(rèn)適宜控制 審查風(fēng)險(xiǎn)并監(jiān)控控制 Quality Risk Assessment質(zhì)量風(fēng)險(xiǎn)評(píng)估 Is it GxP?是否屬于GxP What hazards?有什么危害？ Impact level?影響級(jí)別？ 進(jìn)行最初風(fēng)險(xiǎn)評(píng)估并確定系統(tǒng)影響 確定對(duì)患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性有影響的功能 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Doesthesystemgene

24、rate,manipulateorcontroldata supportingregulatorysafetyandefficacysubmissions?系 統(tǒng)是否生成、處理或控制用于支持法規(guī)安全性和功效提交文件的 數(shù)據(jù)？ Yes/No Doesthesystemcontrolcriticalparametersanddatain preclinical,clinical,development,ormanufacturing?系統(tǒng)是 否控制臨床前、臨床、開(kāi)發(fā)或生產(chǎn)相關(guān)關(guān)鍵參數(shù)和數(shù)據(jù)？ Yes/No Doesthesystemcontrolorprovidedataorinformation

25、for productrelease?系統(tǒng)是否控制或提供有關(guān)產(chǎn)品放行的數(shù)據(jù)或信 息？ Yes/No Doesthesystemcontroldataorinformationrequiredin caseofproductrecall?系統(tǒng)是否控制與產(chǎn)品召回相關(guān)要求的數(shù) 據(jù)或信息？ Yes/No Doesthesystemcontroladverseeventorcompliant recordingorreporting?系統(tǒng)是否控制不良事件或投訴的記錄或 報(bào)告？ Yes/No Doesthesystemsupportpharmacovigilance?系統(tǒng)是否支持 藥物安全監(jiān)視？ Yes/

26、No GxP Assessment GxP評(píng)估 71 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Worstcase impacton patientsafety 對(duì)患者安全的最 差情況影響 High=potentialforseriousinjuryordeath Medium=potentialforminorinjury Low=potentialfor 高=可能造成嚴(yán)重傷害或死亡 中=可能造成輕微傷害 低=可能 Worstcase impacton productquality 對(duì)產(chǎn)品質(zhì)量的的 最差情況影響 High=potentialforreleaseofproductwhichwoul

27、dcauseseriousinjurytoapatient高= 可能放行可能導(dǎo)致患者嚴(yán)重傷害的產(chǎn)品 Medium=potentialforreleaseofproductwhichwouldcauseminorinjurytoapatient中= 可能放行可能導(dǎo)致患者輕微傷害的產(chǎn)品 Low=potentialforpoorqualityproductwhichwouldnotbereleasedorwouldnotcause harmtopatient低=可能導(dǎo)致產(chǎn)生不會(huì)放行或是不會(huì)對(duì)患者造成傷害的低質(zhì)量產(chǎn)品 Worstcase impactondata integrity 對(duì)數(shù)據(jù)完整性的 的

28、最差情況影響 High=lossofdataintegritysuchthatproductrecallcouldnotbecarriedoutorrelease couldbemadeofproductwhichwouldcauseseriousinjurytoapatient高=數(shù)據(jù)完整性喪 失導(dǎo)致不成召回產(chǎn)品或是放行能夠?qū)颊咴斐蓢?yán)重傷害的產(chǎn)品 Medium=lossofdataintegritysuchthatreleasecouldbemadeofproductwhichwould causeminorinjurytoapatient中=數(shù)據(jù)完整性喪失導(dǎo)致放行能夠?qū)颊咴斐奢p微傷害的

29、產(chǎn) 品 Low=lossofdataintegritysuchthatproductwouldneedtobescrappedordatarecords notessentialtoproductreleaseorrecallmightbelostorimpaired低=數(shù)據(jù)完整性喪失導(dǎo) 致產(chǎn)品作廢或數(shù)據(jù)記錄對(duì)產(chǎn)品放行不重要或召回不能或困難 System Impact Classification系統(tǒng)影響性分類(lèi) 72 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) GxPCritical GxP關(guān)鍵 Yes/No 是/否 ImpactLevel 影響級(jí)別 High/Medium/Low 高/中/低 Sy

30、stem Classification 系統(tǒng)分類(lèi) 73 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Risk assessment method風(fēng)險(xiǎn)評(píng)估方法 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Identification of Controls確定控制 The output of the risk assessment process (risk priority) is used to decide upon appropriate controls. A range of options is available to provide the required control dependi

31、ng on the identified risk. These include, but are not limited to: 風(fēng)險(xiǎn)評(píng)估過(guò)程目的是采用合適的控制；依據(jù)所辨識(shí)出的風(fēng)險(xiǎn)級(jí)別可通 過(guò)一組選項(xiàng)實(shí)現(xiàn)控制，這些選項(xiàng)包括以下但不局限以下： Modification of process design or system design 修改流程設(shè)計(jì)或者系統(tǒng)設(shè)計(jì) Application of external procedures通過(guò)外部程序 Increasing the detail or formality of specifications增加規(guī)范細(xì)節(jié) Increasing the n

32、umber and level of detail of design reviews 增加復(fù)查的級(jí)別和次數(shù) Increasing the extent or rigor of verification activities 增加外部的和嚴(yán)格的驗(yàn)證行動(dòng) GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Risk Management Throughout the Life Cycle 整個(gè)生命周期過(guò)程中的風(fēng)險(xiǎn)控制 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Any question? GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) GAMP5 Planning Phase GAMP5

33、計(jì)劃階段 Functional Specification功能說(shuō)明 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Functional Specification功能說(shuō)明 A Functional Specification is a key document in defining how the customer functional requirements, as defined in the user requirements specification, are to be met. 功能說(shuō)明是一種重要的文件，界定了是如何來(lái)滿(mǎn)足在用戶(hù)需求說(shuō)明中所規(guī)定的 客戶(hù)功能要求的。 Functiona

34、l Specification is the responsibility of the supplier 功能說(shuō)明屬于供應(yīng)商的責(zé)任 It is written in response to URS 需要根據(jù)URS進(jìn)行編寫(xiě) It provides the main basis for FAT 它提供了FAT的主要基礎(chǔ) It needs to be approved by User. 需要用戶(hù)批準(zhǔn) Generally may require further revision during the project life cycle. 一般在項(xiàng)目生命周期過(guò)程中需要進(jìn)行修訂 GAMP5及計(jì)算機(jī)化系

35、統(tǒng)驗(yàn)證相關(guān)知識(shí) FS- Contents FS-內(nèi)容 Relationship to other Documents 與其它文件的關(guān)系 Applicable standard適用標(biāo)準(zhǔn) Relationship to customer URS與客戶(hù)URS之間關(guān)系 Non-Conformance with User Requirement與用戶(hù)需求的不符合項(xiàng) Project overview項(xiàng)目概述 Summary of Process to be controlled所需控制工藝概述 Relevant GxP regulations相關(guān)GxP法規(guī) Impact on Patient Safety

36、, Product Quality, data integrity 對(duì)患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性的影響 Project boundaries and interfaces (scope of supply and validation) 項(xiàng)目界限和接口（供貨范圍和驗(yàn)證） System Architecture系統(tǒng)結(jié)構(gòu) System classification: Hardware and software categories 系統(tǒng)分類(lèi)：硬件和軟件類(lèi)別 Assumptions and restrictions 假設(shè)和限制 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Fun

37、ctions FS-內(nèi)容-功能 Functions 功能 Continuous control 連續(xù)控制 Purpose 目的 Operation 操作 Critical parameters involved所涉及關(guān)鍵參數(shù) GxP criticality/impact rating GxP關(guān)鍵性/影響評(píng)定 What equipment it controls 所控制設(shè)備 Category of software 軟件類(lèi)別 Error handling and data checking錯(cuò)誤處理和數(shù)據(jù)檢查 Interface to other modules與其它模塊的界面 GAMP5及計(jì)算機(jī)

38、化系統(tǒng)驗(yàn)證相關(guān)知識(shí) Purposeoffunction 功能目的 Pressurelooptocontrolthedifferentialpressureofthechamber 控制腔體壓差的壓力回路 Criticalprocessparameters 關(guān)鍵工藝參數(shù) ChamberpressurecriticaltotheoperationofSterilizer.ItmustbecontrolledfromthePressurisephasetoDe-pressurisephase.Itiscontrolledto5Pa setpoint 腔室壓力對(duì)滅菌柜的壓力非常關(guān)鍵。必須在從加壓階段到

39、放壓過(guò)程期間進(jìn)行控制。需要控制在設(shè)定點(diǎn)的5Pa。 GxPCritical? 對(duì)GxP是否關(guān)鍵？ Yes是 ImpactratingfromURS 從URS的影響評(píng)級(jí) Low低 Relatedplantequipment 相關(guān)工廠設(shè)備 Inputsignal:ChamberdifferentialPressuresignalPT1.Itmeasuresthedifferencebetweenthechamberpressureandthetechnicalarea. 輸入信號(hào)：腔室壓差信號(hào)PT1。用于衡量腔室壓力和技術(shù)區(qū)壓力之間的差值。 Controlloop:PID控制回路：PID Outpu

40、tDevice:輸出裝置： ExternalFanM67(VFDSC1)isusedforadjustingpressure通過(guò)外部風(fēng)機(jī)M67（VFDSC1）調(diào)節(jié)壓力 Ventvalve(M14)isanon/Offvalvewhichisoperatedbyphasesasrequired.排風(fēng)閥（M14）為開(kāi)關(guān)閥，根據(jù)各階段要求進(jìn)行操作。 Categoryofsoftwareused 所用軟件類(lèi)別 4Configuredmodule4可配置模塊 Interfacestoothermodules 與其它模塊的界面 None無(wú) Moduleoperation 模塊操作 Pressurecont

41、rolloopusestheChamberdifferentialpressureinputsignalandExternalFanVFDtocontroltheChamberpressure.Itacceptsasetpointfromthe RecipeandprovidesaPIDcontrol. 壓力控制回路通過(guò)腔室壓差輸入信號(hào)和外部風(fēng)機(jī)VFD來(lái)控制腔室中的壓力。它從配方中獲得一個(gè)設(shè)定點(diǎn)并進(jìn)行PID控制 Pressure壓力 Ventvalve(M14)isanon/Offvalvewhichisoperatedbyphasesasrequired.排風(fēng)閥（M14）是一個(gè)開(kāi)關(guān)閥，根據(jù)各

42、階段要求進(jìn)行操作。 PressurecontrolloopalwaysstartedautomaticallybytheCycleoperation壓力控制回路總是通過(guò)循環(huán)操作自動(dòng)啟動(dòng) Pressureloopinterlocks:壓力回路有如下互鎖 Pressurecontrolloopcantoperateifeitherloadingorunloadingdoorisopen如果上料門(mén)或是卸料門(mén)在打開(kāi)狀態(tài)，壓力回路不能運(yùn)行 Emergencypushbuttonisactivated.IfthepressureisrunningthenitstopscontrollingbyFansto

43、ppingfanandclosingventvalve急停開(kāi)關(guān)已啟動(dòng)。如果有 壓力則可通過(guò)停風(fēng)機(jī)并關(guān)閉排氣閥停止控制 IfExternalFanmotoroverloadisonthenthepressureloopstops.Alsoheatingstops.如果外部風(fēng)機(jī)電機(jī)過(guò)載開(kāi)，則壓力回路停止。同時(shí)停止加熱 Errorhandlinganddata checking 錯(cuò)誤處理和數(shù)據(jù)檢查 IftheinputsignalorAnalogueModuletothePLCislostanalarmisraisedandPressurecontrolloopsstop.Thiswillalsos

44、topthePressurecontrolloops. 如果PLC輸入信號(hào)或模擬模塊丟失，發(fā)出報(bào)警，壓力控制回路停止。也將停止壓力控制回路。 FS-Contents-Functions FS-內(nèi)容-功能 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Functions FS-內(nèi)容-功能 Functions 功能 Sequential control 順序控制 Purpose目的 Critical parameters involved 所涉及關(guān)鍵參數(shù) GxP criticality/impact rating GxP關(guān)鍵性/影響評(píng)級(jí) What equipment it cont

45、rols 所控制設(shè)備 Category of software軟件類(lèi)別 Interface to other modules 與其它模塊界面 Operation Flow Chart 操作流程圖 Failure modes & error handling 故障模式和錯(cuò)誤處理 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Data FS-內(nèi)容-數(shù)據(jù) Internal Data Structure and Data Flows 內(nèi)部數(shù)據(jù)結(jié)構(gòu)和數(shù)據(jù)流 Describe the data structure 描述數(shù)據(jù)結(jié)構(gòu) Describe interfaces provided 描述

46、所提供界面 Real I/O 真實(shí)I/O Modbus Profibus OPC etc GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Data FS-內(nèi)容-數(shù)據(jù) Process Data工藝數(shù)據(jù) Describe the Inputs 描述輸入 Where does the data originate (eg hardwired I/O, Modbus from another device, etc) ? 數(shù)據(jù)從哪里生成（例如硬件接線(xiàn)I/O、另一裝置的Modbus 等）？ What quality checking is carried out? (eg alarms o

47、n faulty I/O or comms links) 進(jìn)行什么樣的質(zhì)量檢查？（例如故障I/O報(bào)警或comms 鏈接） How is the data stored (e.g. timestamped, how often, what format） 數(shù)據(jù)如何存儲(chǔ)（例如時(shí)間標(biāo)記、存儲(chǔ)頻率、格式） Where is data stored? 數(shù)據(jù)存儲(chǔ)位置？ What capacity is available? 可用容量？ How are live and historical data viewed? 如何查看實(shí)時(shí)數(shù)據(jù)和歷史數(shù)據(jù)？ GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents

48、-Data FS-內(nèi)容-數(shù)據(jù) Alarm Data 報(bào)警數(shù)據(jù) Describe the alarms 對(duì)報(bào)警進(jìn)行描述 Where does the alarm originate? 生成報(bào)警的位置？ Where is it time stamped? 時(shí)間標(biāo)記位置？ How is the alarm stored (e.g. what information, timestamped, what format) 報(bào)警如何存儲(chǔ)（例如什么信息、時(shí)間標(biāo)記、格式）？ Where is data stored?數(shù)據(jù)存儲(chǔ)位置？ What capacity is available?可用容量？ How ar

49、e the current alarm and historical alarms viewed? 如何查看當(dāng)前報(bào)警和歷史報(bào)警？ Alarm Lists 報(bào)警清單 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Data FS-內(nèi)容-數(shù)據(jù) Audit Trail Data 審計(jì)跟蹤數(shù)據(jù) Describe the Inputs 對(duì)輸入進(jìn)行描述 Where does the data originate?生成數(shù)據(jù)的位置？ Where quality checking is carried out (format of operator entries)? 需進(jìn)行什么樣的質(zhì)量檢查（操作

50、員輸入的格式）？ How is the Audit Trail stored (e.g. what information, timestamped, what format) 審計(jì)跟蹤如何存儲(chǔ)（例如什么信息、時(shí)間標(biāo)記、格 式）？ Where is data stored?數(shù)據(jù)存儲(chǔ)位置？ What capacity is available?可用容量？ How are the Audit Trails viewed? 如何查看審計(jì)跟蹤？ Audit trail lists 審計(jì)跟蹤清單 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Data FS-內(nèi)容-數(shù)據(jù) Data Inpu

51、t functions specific to production生產(chǎn)方面具體數(shù)據(jù)輸入功能 Recipes 處方 Describe the structure of recipes 對(duì)處方的結(jié)構(gòu)進(jìn)行描述 Recipes Configuration: new, modify an existing one, etc) 處方配置：新建、更改現(xiàn)有處方等） Recipe types and parametrs for each recipe 處方類(lèi)型和每個(gè)處方的參數(shù) Error checking and handling 錯(cuò)誤檢查和處理 Batch data 批數(shù)據(jù) What Batch data

52、required 需要什么樣的批數(shù)據(jù) Entry batch data (e.g. manually, bar code reader） 批數(shù)據(jù)的輸入（例如手動(dòng)、條形碼讀碼器） Error checking and handling錯(cuò)誤檢查和處理 Calculations 計(jì)算 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Data FS-內(nèi)容-數(shù)據(jù) Data output functions specific to production生產(chǎn)方面具體數(shù)據(jù)輸出功能 Trending趨勢(shì) Live 實(shí)時(shí) Historical 歷史 Reports報(bào)告 Reports type: S

53、hift, Daily, weekly, Batch報(bào)告類(lèi)別：每班、每天、每 周、每批 Report format and contents報(bào)告格式和內(nèi)容 Calculations: Min, Max, Average, etc 計(jì)算：最小、最大、平均等 Report Generation 生成報(bào)告 Report archive and Retrieve報(bào)告的歸檔和檢索 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Data FS-內(nèi)容-數(shù)據(jù) Electronics Records & Electronics Signature, 電子記錄和電子簽名 Compliance wi

54、th 21 CFR Part 11 與21 CFR Part 11 的符合性 Electronics Records 電子記錄 List of data to be stored electronically 需電子存儲(chǔ)的數(shù)據(jù)清單 Electronics Signature電子簽名 Describe Sign, authorisation (double signature) 對(duì)簽名、權(quán)限（雙重簽 名）進(jìn)行描述 Describe Functions which require Electronics signature and Access level 對(duì)要求電子簽名和訪問(wèn)級(jí)別的功能進(jìn)行描述

55、Describe Parameters which require Electronics signature 對(duì)要求電子簽名的參數(shù)進(jìn)行描述 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Interfaces FS-內(nèi)容-界面 Process Equipment 工藝設(shè)備 I/O List 輸入/輸出清單 Tag 標(biāo)號(hào) Type類(lèi)型 Description 說(shuō)明 Range范圍 I/O module, Channel allocation 輸入/輸出模塊、 通道分配 Display format 顯示格式 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Inter

56、faces FS-內(nèi)容-界面 Internal Network 內(nèi)部網(wǎng)絡(luò) Network Type 網(wǎng)絡(luò)類(lèi)型 Physical connections 物理連接 Network setting 網(wǎng)絡(luò)設(shè)定 Protocol 協(xié)議 Data to be transferred 所需傳輸數(shù)據(jù) External Network 外部網(wǎng)絡(luò) Network type網(wǎng)絡(luò)類(lèi)型 Physical connections物理連接 Protocol conversion devices 協(xié)議轉(zhuǎn)換裝置 Network setting網(wǎng)絡(luò)設(shè)定 Protocol 協(xié)議 Data to be transferred所需傳

57、輸數(shù)據(jù) GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Interface Functions FS-內(nèi)容-界面功能 Alarms 報(bào)警 Alarm priority structure 報(bào)警優(yōu)先級(jí)別結(jié)構(gòu) Alarm grouping 報(bào)警分組 Alarm Displaying and Acknowledgment 報(bào)警顯示和確認(rèn) Alarm types (process, system, etc) 報(bào)警類(lèi)別（工藝、系 統(tǒng)等） Events and Messaging 事件和消息 Displays 顯示 Standard 標(biāo)準(zhǔn) Custom 定制 Navigation 導(dǎo)航 GA

58、MP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Interface Functions FS-內(nèi)容-界面功能 Access Control 訪問(wèn)控制 Setting 設(shè)定 Max login attempts 最多嘗試登錄次數(shù) Password expiry period 密碼失效期 Password re-use period 密碼重新使用期 Minimum user ID length 最小用戶(hù)名長(zhǎng)度 Maximum user ID length 最大用戶(hù)名長(zhǎng)度 Minimum password length 最小密碼長(zhǎng)度 Maximum password length 最大密碼

59、長(zhǎng)度 Security Group 安全分組 Operator 操作員 Engineer 工程師 Admin管理員 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Interface Functions FS-內(nèi)容-界面功能 Access Rights 訪問(wèn)權(quán)限 Function功能 Access Right 訪問(wèn)權(quán)限 User Accounts: 用戶(hù)賬戶(hù) User ID 用戶(hù)名 Full name 全名 Access Level 訪問(wèn)級(jí)別 GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí) FS-Contents-Disaster Recovery FS-內(nèi)容-災(zāi)難恢復(fù) Power Out

60、age 斷電 What happens to outputs on loss of power? 斷電時(shí)輸出將如何反應(yīng)？ What happens to programs / configurations on loss of power? 斷電時(shí)程序/配置將如何反應(yīng)？ What happens on restart cold / warm / tepid? 冷/熱/溫重啟時(shí)將如何反應(yīng)？ What happens to outputs on restart?重啟時(shí)輸出將如何反應(yīng)？ What happens to run-time data on restart?重啟時(shí)運(yùn)行時(shí)數(shù)據(jù)將如何反應(yīng)？ E