1、Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 1 of 14Component Criticality Assessment Report forXXX SystemXXX系統部件關鍵性評估報告Approval for Report 報告批準Company/Title公司/職務Name姓名Signature簽名Date日期Written by 編寫Reviewed by審核Approved by批準Rev.版本Date日期Revision Reasons

2、 修訂原因00Initial issuance 新制訂Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 2 of 14Index 目錄1. Purpose 目的 32. Scope 范圍33. Responsibility職責34. Regulation and Guidance 法規和指南 45. Abbreviations縮略語56. Description系統描述57. Reference Documents參考文件 68. Method of Com

3、ponent Criticality Assessment部件關鍵性評估方法 78.1 Identification of Component Criticality部件關鍵性的確認 78.2 Critical Component Risk Assessment關鍵性部件風險評估 89. Performance of Component Criticality Assessment部件關鍵性評估執行 119.1 Identification of Component Criticality部件關鍵性確認 119.2 Critical Component Risk Assessment關鍵性部件

4、風險評估 1210. Conclusion結論13Appendix 1 The summary of planned control actions for the medium and high risks附錄 1 中、高級風險控制措施匯總表 14Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 3of141. Purpose 目的An individual component criticality assessment will be performe

5、d for the XXX system in the XXX Plant of XXX and documented on the following pages. This component criticality assessment is used to assess the criticality of each of the components of the direct impact systems. Risk assessment will be performed for a component assessed to be critical to identify al

6、l the potential risks and their impacts on products. This activity can effectively decrease the scope ofqualification activities. Critical components will be subject to commissioning and qualification and non-critical components will be subject to commissioning only. It also defines the qualificatio

7、n activities for the validation/qualification process and the recommended actions during the operation process.XXX公司XXX車間XXX系統進行單獨的部件關鍵性評估并記錄在如下文件中。本部件關鍵性評估是 評估直接影響系統中各部件的關鍵程度。對判定為關鍵性的部件進行風險評估用于確定出所有的潛在 危險及其對產品的影響。本項工作能夠有效的縮小確認工作的范圍，從而對關鍵性部件進行調試和確 認，對非關鍵性部件僅需進行調試。它還規定出了驗證/確認過程中所需進行的活動、操作過程中的建議措施等。2.

8、 Scope 范圍The scope of this component criticality assessment includes theXXX system (Equipment LocationNo.: XXX) in the XXX Room (Room No.: XXX) on the XXX floorfor the XXX Plant ofXXXX. Thesystem No. is XXX .本部件關鍵性評估的范圍為XXX公司XXX車間XXX樓層XXX房間(房間編號：)XXX系統(設備位號：XXX),系統編號：XXX。3. Responsibility 職責Informat

9、ion collection信息的收集Supply all procedure, data, manuals, drawing and documentation necessary for the completion offinal report提供為報告編寫所需要的所有的規程、數據、手冊、圖紙和文件Components Criticality Assessment execution進行部件關鍵性評估CCA Report compilation部件關鍵性評估報告的編寫Review and approve the report報告的審核和批準Component Criticality As

10、sessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage頁碼Page 4 of 144. Regulation and Guidance法規和指南(CFDA) GMP (2010 Revision)(CFDA) GMP(2010 年修訂版)ISPE Baseline guide Volume 5 commissioning and qualificationISPE指南5 "調試和確認”ICH Harmonized Tripartite Guideline Quality Risk Management Q9, An

11、nex I,2.ICH三方協調指導原則質量風險管理Q9 ,附錄1 , 2GAMP 5 (Good Automated Manufacturing Practice 5)GAMP 5良好的自動化制造規范5(ISPE)Pharmaceutical Engineering Guides for New and Renovated facilities, Volume 4:Water and steam systems(ISPE)新建和改造的工廠醫藥工程指南，第 4卷-水和蒸汽系統(ISPE) Good Practice Guide : Commissioning and Qualification

12、of Pharmaceutical Water andSteam System(ISPE)制藥用水和純蒸汽調試和確認指南Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 5 of 145. Abbreviations 縮略語Abbreviations縮略語Definition定義CCAComponent Criticality Assessment 部件關鍵性評估RARisk Assessment風險評估RPNRisk Priority Number風險優先

13、性IQInstallation Qualification安裝確認OQOperation Qualification 運行確認PQPerformance Qualification 性能確認GMPGood Manufacturing Practice 藥品生產質量管理規范SOPStandard operation procedure 標準操作程序6. Description系統描述This system is the XXXX system in the XXX Plant of XXX.本系統為XXX公司XXX車間XXX系統。對該系統/設備的作用、生產商、詳細的位置（關鍵設備要寫出背景級別）

14、、主要的部件及其功能進行詳細描述。Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 6 of 147. Reference Documents 參考文件Document Name文件名稱Document No.文件號Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 7 of 148. Method of Component

15、 Criticality Assessment部件關鍵性評估方法8.1 Identification of Component Criticality部件關鍵性的確認GMP critical functions and components are evaluated compared to their impacts on the product.根據功能和部件對產品的影響來評估其GMP關鍵程度。The GMP impact assessment of the functions and components is based on the 5 quality values (efficie

16、ncy, identity, security, purity, quality) waited from the product.功能和部件的GMP影響評估以產品的5個質量參數為基礎(功效、特性、安全、純度、質量)The criticality component impact assessment is based on the functional and split of the system. For each primary function, all the equipments, components and instruments providing this functio

17、n are classified in critical or not critical according to the following questions:部件關鍵性評估將以系統為單位進行，這些系統是按照功能劃分的。對于每一項會對產品質量產生影 響的功能、所有提供該功能的設備、部件或儀表都歸類為關鍵和非關鍵兩種，這種歸類將根據下列問 題進行：1- Is the component used to demonstrate compliance with the registered process?部件是否用于證明符合所注冊工藝的規定？2- Does the normal operati

18、on or control of the function/component have a direct effect on product quality or efficacy?功能/部件的正常操作或控制對產品質量或功效具有直接的影響？3- Does the failure or alarm of the function/component have a direct effect on product quality or efficacy?功能/部件的故障或報警是否對產品質量或功效具有直接影響？4- Is the information from this function/com

19、ponent recorded as part of the batch record, lot release data, or other GMP related documentation?從功能/部件獲取的信息被記錄為批記錄、批放行數據或其它GMP相關文件的一部分?5- Does the component have direct contact with the product, product ingredients or product inner-packaging?部件是否與產品、產品成分或產品內包材直接接觸？6- Does the function/component co

20、ntrol critical process elements that may affect productquality without independent verification of the control system performance?功能/部件是否用于控制可以影響產品質量的關鍵工藝參數，而對控制系統性能無獨立的驗 證？7- Is the function/component used to create or preserve a critical status of a system?Component Criticality Assessment Report f

21、or XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 8 of 14功能/部件用于創建或保持某種系統的關鍵狀態？The answer yes "to one of the 7 questions means that the function/component is critical.七個問題中只要有一個問題的答案是Yes”，就將該功能/部件歸類為關鍵的功能/部件。Y" YesN" No"N/A:"not applicable“Y"：是"N'：否"N/A

22、:“不適用8.2 Critical Component Risk Assessment 關鍵性部件風險評估According to the result of component criticality assessment, continue to assess the risk of critical component.根據部件關鍵性評估的結果，對關鍵性部件要繼續進行風險評估。Risk will be expressed using qualitative descriptor s, such as "high " ,"medium” , or A risl

23、oscoreis used to define descriptors in Risk Priority.風險評估表達使用定性描述，如高"中"'低一個風險的判定依靠風險優先性來定義。A. Probability 可能性How is the probability that the described failure will occur (according the described failure sources) 如何描述失敗發生的可能性(依據失敗來源的描述)？o Low (L): Due to the design failures may not occu

24、r. The design is well known and often used. Rare quality events.低(L):由設計造成的失敗幾乎不會發生。設計是熟知的并經常使用的。幾乎沒有質量問 題。o Medium (M): Infrequent quality events.中(M):極少發生質量問題。o High (H): The design is new and not well known. There is a high probability that failures occur. Frequent quality events.高(H)：新的并且是不太熟悉的設

25、計。有很高發生失敗的可能性。經常會發生質量問題。B. Severity 嚴重性Which impact has the described failure (even if there is no high probability of failure)?對失敗可能造成的影響進行描述(即使沒有失敗發生的大的可能性)。o Low (L): No impact to the product quality.低(L):對產品質量無影響。o Medium (M): Middle impact to product.中(M):對產品質量有中等程度的影響。o High (H): High impact t

26、o product.Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage頁碼Page 9 of 14tWj ( H):對產品質量有較大影響。C. Detection 可檢測性Understanding the detectability of a failure also assists in selection of appropriate controls to manage the identified risks. Failure maybe detected aut

27、omatically by the automation system or by manual methods.了解故障的可檢測性也可以幫助選擇適宜的控制方法對所確定的風險進行控制。故障可以通過自控系統自動檢測，或是通過手動方法進行檢測。How is the probability that the described failure detection ?如何描述故障的可檢測性？o Low (L): Unlikely to be identified by an operator or by equipment control system. 低(L):不太可能由操作人員或設備控制系統查到

28、。o Medium (M): Easily identified by an operator or has an alarm. 中(M):可由操作人員很容易地查到或具有報警。o High (H): Automatically detected by the equipment control and alarming, recovery action can be taken automatically.高(H):通過設備控制系統自動檢測并報警，可能自動采取恢復措施。D. Risk assessment風險評估：According to the following procedure cal

29、culates risk assessment:按以下流程進行風險評估：The severity and probability rating will be combined to evaluate Risk Class. The following method will be used to define the Risk Class.將把嚴重性和可能性合在一起來評價風險等級。將采用如下方法來確定風險等級：Component Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Pag

30、e 10 of 14Risk Class風險等級Low Probability可能性低Medium Probability可能性中等High Probability可能性高High ImpactRisk Class 2Risk Class 1Risk Class 1嚴重性高風險等級2風險等級1風險等級1Medium ImpactRisk Class 3Risk Class 2Risk Class 1嚴重性中風險等級3風險等級2風險等級1Low ImpactRisk Class 3Risk Class 3Risk Class 2嚴重性低風險等級3風險等級3風險等級2In this step Ri

31、sk Priority will be evaluated. Following the evaluation Risk Class and probability of detection are combined to give the overall risk priority: Risk Priority is evaluated by : 在此步將對風險優先性進行評價。在進行評價之后，將風險等級和可檢測性合并到一起來確定整體的風險優先性，通過如下方式對風險優先性進行評價：Risk Priority風險優先性Low Probability of Detection 檢測可能性低Medi

32、um Probability of Detection檢測可能性中等High Probability of Detection 檢測可能性高Risk Class 1風險等級1High Risk Priority風險優先性高High Risk Priority風險優先性高Medium Risk Priority風險優先性中Risk Class 2風險等級2High Risk Priority風險優先性高Medium Risk Priority風險優先性中Low Risk Priority風險優先性低Risk Class 3風險等級3Medium Risk Priority風險優先性中Low Ri

33、sk Priority風險優先性低Low Risk Priority風險優先性低For purposes of planning, each critical component inherits the highest risk priority of any function it performs. For medium and high risk priority, a reasonable proposal must be given and appropriate control method is made.評估的目的，是每個關鍵部件將根據其所執行的功能而確定其最高的風險優先級別

34、。風險等級為中高級必須給出合理建議，并決定適宜的控制方法。After giving the recommended action, the probability, severity and detection probability are assessed again to obtain the risk priority.給出建議措施之后再次對可能性、嚴重性和可檢測性進行評估，得到風險優先性。The recommended risk control actions shall be commented.需對建議風險控制措施進行評論。Component Criticality Assess

35、ment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage頁碼Page 11 of 149. Performance of Component Criticality Assessment部件關鍵性評估執行9.1 Identification of Component Criticality部件關鍵性確認Component / Function部件/功能Questions問題Is it critical?是否為 關鍵部件1234567Component Criticality Assessment Report forXXX Plant

36、xxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 12 of 149.2 Critical Component Risk Assessment關鍵性部件風險評估Function/Component 功能/部件Description/Task 說明/任務Failed Event失效事件Worst Case Effect 最差情況影響e' s 嚴重性可能端yrce s 可檢測藤風 險 優 先RP ectabiliRecommendedControl ActionsN建議控制措施ye s 嚴重性c料 可能第e啊 可檢測斯風 險 優 先RP ectabiliCommentsN評論tyComponent Criticality Assessment Report for XXX Plantxxx車間部件關鍵性評估報告Doc. No.文件編號XXXPage 頁碼Page 13 of 1410. Conclusion 結論The Component Criticality Assessment (CCA) was performed was performed by a validation team of XXX from xxx, 2011 to xxx 2011 . The assessment conclus