藥品質(zhì)量風(fēng)險(xiǎn)評(píng)估管理規(guī)程

1、標(biāo) 題：起草人年月日藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Written ByTitle:年月日Quality Risk Management Procedure審核人編 號(hào) Document number ：Reviewed By年月日Q/GS G04. 016-11ZG版 本： 第一版頁 號(hào)：批準(zhǔn)人年月日Version ：0101/19Approved byPage ：制訂部門： 質(zhì)量管理部生效日期：年月日Writtendepartment:Quality Management Effective date ：Department分發(fā)部門： QA 辦、 QC 辦、粉針車間、合成車間、設(shè)備辦、物控辦、人力資源

2、部、行政辦、研發(fā)部、銷售部Distribution to:R&D, QA, QC, API Workshop, Powder for injection Workshop, Logistics, Engineering, HR, Administration、 SalesDepartment1.目的 Objective建立質(zhì)量風(fēng)險(xiǎn)管理程序，對(duì)可能影響到最終產(chǎn)品質(zhì)量的風(fēng)險(xiǎn)因素進(jìn)行確定，評(píng)估和控制，保證最終的產(chǎn)品質(zhì)量。指導(dǎo)公司規(guī)避質(zhì)量事故或藥害事件的發(fā)生，保護(hù)患者的切身利益。The Quality Risk Management Procedure is established to de

3、fine, evaluate and control potential risks to productquality, and to help to avoid adverse quality issues or accidents so as to assure patient benefit.2.范圍 Scope適用于公司質(zhì)量體系內(nèi)的質(zhì)量風(fēng)險(xiǎn)管理。This procedure applies to quality risk management of Gosun quality system.3. 責(zé)任 Responsibilities3.1 所有人員職責(zé)：按本規(guī)程執(zhí)行質(zhì)量風(fēng)險(xiǎn)評(píng)估，準(zhǔn)

4、備文件。It is the responsibility of all personnel conducting Quality Risk Assessment and preparing the documents to adhere to this procedure.3.2 質(zhì)量風(fēng)險(xiǎn)管理組長(zhǎng)Team leader of quality risk management3.2.1 負(fù)責(zé)協(xié)調(diào)跨職能和部門的質(zhì)量風(fēng)險(xiǎn)管理。Take responsibility for coordinating quality risk management across various functions and

5、 departments of the organization.3.2.2 確保質(zhì)量風(fēng)險(xiǎn)管理程序按本SOP 規(guī)定執(zhí)行，并且有充足的資源可用。Assure that the quality risk management process as defined in this SOP is followed and that adequate resources are標(biāo) 題：版 本：第一版頁 號(hào)： 02/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04.

6、 016-11ZGavailable.3.3 質(zhì)量受權(quán)人：負(fù)責(zé)批準(zhǔn)質(zhì)量風(fēng)險(xiǎn)評(píng)估表及關(guān)閉風(fēng)險(xiǎn)管理程序。The Qualified Person: approve < Quality risk assessment sheet > and closing of a risk management process.3.4 QA 辦：負(fù)責(zé)審核在產(chǎn)品生命周期內(nèi)對(duì)其質(zhì)量風(fēng)險(xiǎn)進(jìn)行評(píng)估、控制、信息交流和回顧評(píng)審的系統(tǒng)化過程。QA Office: review the systematic process of evaluation, control, communication and revie

7、w of quality risks during the life circle of products.4. 引用標(biāo)準(zhǔn)及文件References藥品生產(chǎn)質(zhì)量管理規(guī)范（現(xiàn)行版）<China Good Manufacture Practice > (current )EU GMP 指 南 Volume 4<EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use （ Volume 4 ） > ICH Q95. 內(nèi)容 Contents5.1 定義

8、 Definition5.1.1 可測(cè)定性：發(fā)現(xiàn)或測(cè)定危險(xiǎn)源存在的能力Detectability - the ability to discover or determine the existence, presence, or fact of a hazard.5.1.2 危害：對(duì)健康的傷害，包括產(chǎn)品質(zhì)量缺陷或可獲得性造成的傷害Harm - damage to health, including the damage that can occur from loss of product quality or availability.5.1.3 危險(xiǎn)源：潛在的危害來源。Hazard -

9、the potential source of harm.5.1.4 質(zhì)量風(fēng)險(xiǎn)管理：一套系統(tǒng)的程序，用于藥物產(chǎn)品生命周期中的風(fēng)險(xiǎn)評(píng)估、控制、信息交流以及回顧。Quality risk management - a systematic process for the assessment, control, communication and review of risks tothe quality of the drug (medicinal) product across the product life cycle.5.1.5 可能性：有害事件發(fā)生的頻率或可能性。Likelihood

10、- frequency or probability of the adverse event occurring.5.1.6 嚴(yán)重性：對(duì)危險(xiǎn)源可能造成的后果的衡量Severity - A measure of the possible consequences of a hazard.標(biāo) 題：版 本：第一版頁 號(hào)： 03/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZG5.1.7 風(fēng)險(xiǎn)評(píng)估：對(duì)可能造成系統(tǒng)故障的原因進(jìn)行仔細(xì)檢查，以便

11、做出合理可行的決策，減少或者預(yù)防故障的發(fā)生。Risk Assessment - A careful examination of what could cause failure of the system so that decisions can be made about what is reasonably practicable to reduce or prevent malfunctions.5.2 質(zhì)量風(fēng)險(xiǎn)管理程序的適用范圍包括并不局限于以下情況：This quality risk management procedure applies but not limited to

12、the following issues:5.2.1 確定潔凈房間和潔凈空氣設(shè)施的監(jiān)控位置。Defining environmental monitoring positions of clean room and HVAC systems;5.2.2 設(shè)定生產(chǎn)的標(biāo)準(zhǔn)和工藝參數(shù)。Establishing limits and parameters of manufacturing process;5.2.3 評(píng)估變更影響。Evaluating effect of changes;5.2.4 確定偏差調(diào)查和糾正措施的程度。Determining levels of deviation inves

13、tigations and correction actions;5.2.5 評(píng)估工藝的薄弱和高風(fēng)險(xiǎn)區(qū)。Evaluating and defining weakness and high-risk issues of manufacturing process.5.3 質(zhì)量風(fēng)險(xiǎn)管理流程Quality Risk Management Process標(biāo) 題：版 本：第一版頁 號(hào)： 04/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZG5.

14、4 啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理程序標(biāo) 題：版 本：第一版頁 號(hào)： 05/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGInitiating a Quality Risk Management Process.5.4.1 執(zhí)行以下步驟，啟動(dòng)并計(jì)劃質(zhì)量風(fēng)險(xiǎn)管理程序。A quality risk management process is planned and initiated as follows:5.4.1.2 確定風(fēng)險(xiǎn)項(xiàng)目Define t

15、he risk question確定難題或風(fēng)險(xiǎn)問題，包括對(duì)相關(guān)潛在風(fēng)險(xiǎn)的設(shè)想。質(zhì)量風(fēng)險(xiǎn)評(píng)估從一個(gè)定義明確的難題或風(fēng)險(xiǎn)疑問開始。Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk. Qualityrisk assessments begin with a well-defined problem description or risk question.5.4.1.3 組建質(zhì)量風(fēng)險(xiǎn)管理小組Organize a quality risk

16、 management team由難題或風(fēng)險(xiǎn)問題部門負(fù)責(zé)人或其指定的人員擔(dān)任組長(zhǎng)，風(fēng)險(xiǎn)管理小組的成員應(yīng)該至少包括該難題或風(fēng)險(xiǎn)問題部門的成員及QA 人員。同時(shí)根據(jù)需要，也可以邀請(qǐng)其他相關(guān)部門的專業(yè)成員參加。The person in charge of or the person designated by the person in charge of the department which possesses theproblem or risk question is designated as the leader of quality risk management team, an

17、d personnel engaged in thedepartment whichpossesses the problem or risk question QA personnel should be involvedin the qualityriskmanagement team at least. Experts of other relevant department might be involved in the team, where necessary.5.4.1.4 風(fēng)險(xiǎn)管理小組組長(zhǎng)，搜集潛在危險(xiǎn)源、危害或風(fēng)險(xiǎn)評(píng)估相關(guān)的人員健康影響的背景資料或數(shù)據(jù)，并向風(fēng)險(xiǎn)管理小組的成

18、員講解整個(gè)項(xiàng)目的情況，幫助風(fēng)險(xiǎn)管理小組成員了解整個(gè)項(xiàng)目。The leader of quality risk management team assembles background information and/or data on the potential hazard,harm or human health impact relevant to the risk assessment and explains the program to team members to help themget to know this program.5.4.1.5 風(fēng)險(xiǎn)管理小組成員依據(jù)自己的專

19、業(yè)，使用5.6 中介紹的質(zhì)量風(fēng)險(xiǎn)管理方法，找到該項(xiàng)目中可能存在的影響到產(chǎn)品質(zhì)量的危險(xiǎn)源，并對(duì)這些危險(xiǎn)源進(jìn)行分析討論，確認(rèn)各類危險(xiǎn)源對(duì)最終產(chǎn)品質(zhì)量影響的嚴(yán)重性，風(fēng)險(xiǎn)管理小組組長(zhǎng)根據(jù)最后的風(fēng)險(xiǎn)分析的結(jié)果，起草質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04.016- R 1）第一部分內(nèi)容，質(zhì)量風(fēng)險(xiǎn)評(píng)估表第一部分的內(nèi)容應(yīng)包括但不限于：風(fēng)險(xiǎn)項(xiàng)目名稱、存在的危險(xiǎn)源、風(fēng)險(xiǎn)發(fā)生后的危害、目前的控制方式等。According to their expertise, quality risk management team members employ the quality risk management tools liste

20、d in article 5.6 to identify and analyze potential risk sources that may affect product quality and define the severity; the team leader prepare the first part of Quality Risk assessment Sheet (No.: G04.016- R1 ) based on the conclusion of標(biāo) 題：版 本：第一版頁 號(hào)： 06/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Docu

21、ment number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGrisk analysis. The content of Quality Risk assessment Sheet includes but is not limited to name of the risk question, existing hazard resources, possible consequences and current controls, etc.5.4.1.6 明確風(fēng)險(xiǎn)評(píng)估的計(jì)劃開始時(shí)間和完成時(shí)間Specify the timeli

22、ne of risk management process.5.4.2 質(zhì)量風(fēng)險(xiǎn)分析報(bào)告交相關(guān)部門會(huì)審，QP 批準(zhǔn)質(zhì)量風(fēng)險(xiǎn)評(píng)估的啟動(dòng)。After being finished, the quality analysis report is reviewed by relevant departments and approved by QualifiedPerson before the quality risk assessment program is initiated.5.4.3 從質(zhì)量管理部文件QA處取得質(zhì)量風(fēng)險(xiǎn)評(píng)估編號(hào)，按以下方式編號(hào)：QRA yy-mm-dd ， yy為兩位年號(hào)，

23、mm 為兩位月號(hào)， dd 為兩位月度流水號(hào)。文件 QA 發(fā)放編號(hào)的同時(shí)登記質(zhì)量風(fēng)險(xiǎn)管理臺(tái)帳 （編號(hào)：G04. 016-R3）。The QA personnel in charge of documentation assigns a number to quality risk assessment in the form of“QRAyy-mm- dd” , where “ yy ” is the last two figures of the year, “ mm” the two sequential numbers which are renewed monthly. The assi

24、gned number is recorded in Log (No.: G04. 016-R 3 ) by the QA personnel in charge of documentation.is the two figures indicating the month,Quality Risk Management5.5 執(zhí)行正式風(fēng)險(xiǎn)評(píng)估Deploy a risk assessment5.5.1 按以下步驟執(zhí)行風(fēng)險(xiǎn)評(píng)估The risk assessment is deployed as follows:5.5.1.1 質(zhì)量風(fēng)險(xiǎn)評(píng)估啟動(dòng)后，由風(fēng)險(xiǎn)管理小組組長(zhǎng)組織小組成員，或邀請(qǐng)其它相關(guān)部

25、門的專業(yè)成員，填寫質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04.016- R1）第二部分內(nèi)容 執(zhí)行正式風(fēng)險(xiǎn)評(píng)估，第二部分的內(nèi)容應(yīng)包括但不限于：數(shù)據(jù)評(píng)估（總結(jié)數(shù)據(jù)的充分性，有效性及其他相關(guān)方面）、風(fēng)險(xiǎn)識(shí)別、風(fēng)險(xiǎn)分析及評(píng)估、擬定采用的控制方式，風(fēng)險(xiǎn)控制實(shí)施的標(biāo)準(zhǔn)等。After a risk assessment is initiated, members of the qualityrisk management team and/or experts of relevantdepartments, organized by the team leader, fill out the second part of

26、 Quality Risk assessment Sheet (No.: G04.016- R1 ) with (including but not limited to) data assessment (adequacy, effectiveness and other related aspects of the data), risk identification, risk analysis and evaluation, proposed risk control methods, acceptance criteria of execution of risk control,

27、etc.5.5.1.1.1 由風(fēng)險(xiǎn)管理小組組長(zhǎng)組織小組成員，或邀請(qǐng)其它相關(guān)部門的專業(yè)成員，收集相關(guān)數(shù)據(jù)（歷史數(shù)據(jù)、理論分析、已知的見解或相關(guān)利益者的關(guān)注點(diǎn)），并總結(jié)數(shù)據(jù)的充分性、有效性及其他相關(guān)方面。填入質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)： G04.016- R 1）的 “數(shù)據(jù)評(píng)估 ”中。Members of the quality risk management team and/or experts of relevant departments, organized by the team標(biāo) 題：版 本：第一版頁 號(hào)： 07/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào)

28、Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGleader, assemble relevant data (historical data, theoretical analysis, informed opinions or concerns of stakeholders),summarize adequacy, effectiveness and other relevant aspects and fill out the“Data QuEvalityluation”Risk assessment

29、 Sheet (No.: G04.016- R1 ).5.5.1.1.2 風(fēng)險(xiǎn)管理小組成員依據(jù)自己的專業(yè)，根據(jù)風(fēng)險(xiǎn)提問（什么可能出錯(cuò)？）和問題描述，系統(tǒng)地利用“數(shù)據(jù)評(píng)估 ”中的信息來確定該項(xiàng)目中可能存在的影響到產(chǎn)品質(zhì)量的危險(xiǎn)源，并填入質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04.016- R 1）的 “風(fēng)險(xiǎn)識(shí)別 ”中。According to their expertise, quality risk management team members use fundamental questionwrong ”and information listed in“ Data Evaluation” mentio

30、ned above to identify hazards referring to the risk quor problem description and fillout the“ Risk Identification” Qualityitemof Riskthe assessment Sheet (No.: G04.016-R1 ).5.5.1.1.3 風(fēng)險(xiǎn)分析及評(píng)估：風(fēng)險(xiǎn)管理小組對(duì)這些危險(xiǎn)源進(jìn)行分析討論，確認(rèn)各類危險(xiǎn)源對(duì)最終產(chǎn)品質(zhì)量影響的嚴(yán)重性以及風(fēng)險(xiǎn)發(fā)生的可能性。如若可能，可應(yīng)用風(fēng)險(xiǎn)管理工具分析和評(píng)價(jià)風(fēng)險(xiǎn)。風(fēng)險(xiǎn)管理工具的適用性由危險(xiǎn)源的特點(diǎn)和可能造成的嚴(yán)重性確定。Risk ana

31、lysis and evaluation: the risk management team estimate hazard resources, define the severity of harms and likelihood of occurrence. Analyze and evaluate risk using risk management tools if appropriate. The appropriateness of the tool will be justified by the nature and probable severity of the haza

32、rd. 風(fēng)險(xiǎn)控制的目的是為了減少或降低風(fēng)險(xiǎn)使其達(dá)到可接受水平。某種情況下，風(fēng)險(xiǎn)是可接受的。當(dāng)風(fēng)險(xiǎn)超過可接受水平時(shí)，必須采取相關(guān)措施以降低或避免質(zhì)量風(fēng)險(xiǎn)。The purpose of risk control is to reduce the risk to an acceptable level. In some instances, it is appropriate to accept the risk. When risk exceeds an acceptable level then measures must be proposed for mitigation or avoida

33、nce of quality risk. 風(fēng)險(xiǎn)減少一般包括危害的嚴(yán)重性和可能性的降低。Risk reduction will generally include actions taken to mitigate the severity and probability of harm. 提高危害的可測(cè)定性的步驟和引起的質(zhì)量風(fēng)險(xiǎn)也可作為風(fēng)險(xiǎn)控制策略的一部分。Processes that improve the detectability of hazards and quality risks may also be used as part of a risk controlstrategy

34、.風(fēng)險(xiǎn)控制方式與風(fēng)險(xiǎn)的嚴(yán)重性相呼應(yīng)。標(biāo) 題：版 本：第一版頁 號(hào)： 08/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGThe ways of the quality risk management process should be commensurate with the level of risk. 評(píng)估降低風(fēng)險(xiǎn)影響的措施，這些措施可能造成新的風(fēng)險(xiǎn)或增加早前風(fēng)險(xiǎn)的嚴(yán)重性。Evaluate the impact of risk

35、 reduction measures that may introduce new risk or increase the significance of earlyrisk.5.5.1.2 風(fēng)險(xiǎn)管理小組組長(zhǎng)依據(jù)風(fēng)險(xiǎn)控制方式制定風(fēng)險(xiǎn)控制方式實(shí)施計(jì)劃，實(shí)施計(jì)劃中應(yīng)該包括，但不局限于以下內(nèi)容：風(fēng)險(xiǎn)控制方式、控制方式的開始時(shí)間、控制方式的完成時(shí)間、控制方式的負(fù)責(zé)部門及負(fù)責(zé)人等。According to the risk controlmeasures the leader ofrisk management team prepare a risk control plan,whichinclud

36、es but is not limited to risk control measures, starting time and closing time of risk control measures, responsibleperson and responsible department for implementation of risk control measures, etc.5.5.1.3 質(zhì)量風(fēng)險(xiǎn)分析報(bào)告交相關(guān)部門會(huì)審，QP 批準(zhǔn)質(zhì)量風(fēng)險(xiǎn)分析結(jié)果。Quality risk analysis reports are reviewed by relevant departme

37、nts and the conclusions of quality risk analysis areapproved by the Qualified Person.5.6 質(zhì)量風(fēng)險(xiǎn)管理記錄Documentation of quality risk managementQA 在質(zhì)量風(fēng)險(xiǎn)管理記錄（編號(hào)：of quality risk controls is recorded inG04. 016- R2 ）中記錄所有的質(zhì)量風(fēng)險(xiǎn)控制實(shí)施情況。 Quality Risk Management Record (No.: G04. 016- R 2) byImplementationQA.5.7 質(zhì)

38、量風(fēng)險(xiǎn)分析的方法Quality risk analysis methodology在風(fēng)險(xiǎn)分析及評(píng)估過程中，如若可能，應(yīng)用風(fēng)險(xiǎn)管理工具分析和評(píng)估風(fēng)險(xiǎn)。風(fēng)險(xiǎn)評(píng)估工具的適用性由危險(xiǎn)源的特點(diǎn)和可能造成的嚴(yán)重性確定。Analyze and evaluate risk using risk management tools if appropriate. The appropriateness of the tool will bejustified by the nature and probable severity of the hazard.基本風(fēng)險(xiǎn)管理工具有：Basic risk managem

39、ent tools include:a) 簡(jiǎn)易化工具（流程圖、檢查表、頭腦風(fēng)暴等等）Facilitation devices (flow charts, check sheets, brainstorming, etc)b) 失敗模式效果分析（ FMEA ）Failure Mode Effects Analysis (FMEA)標(biāo) 題：版 本：第一版頁 號(hào)： 09/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGc) 危害分析及關(guān)鍵控

40、制點(diǎn)（HACCP ）d) 魚骨圖分析 Fishbone Analysise) 支持的統(tǒng)計(jì)學(xué)工具 Supporting statistical tools- 某些質(zhì)量風(fēng)險(xiǎn)管理工具檢測(cè)危險(xiǎn)的能力（可測(cè)定性）被認(rèn)為是對(duì)風(fēng)險(xiǎn)的評(píng)估。- In some risk management tools, the ability to detect the harm (detectability) is considered in the estimation ofrisk.- 風(fēng)險(xiǎn)評(píng)估的結(jié)果要么是對(duì)風(fēng)險(xiǎn)的定量評(píng)估，要么是對(duì)風(fēng)險(xiǎn)范圍的定性描述。當(dāng)風(fēng)險(xiǎn)被定性描述為“高”“中 ”“低 ”時(shí)，盡量要對(duì)其進(jìn)行詳細(xì)描述。

41、- The output of a risk assessment will either be a quantitative estimate of risk or a qualitative description of a range of risk. When risk is expressed using qualitative descriptors, such as “ high ”“,medium”or, “ low ”these, must be defined in as much detail as possible.5.8 風(fēng)險(xiǎn)評(píng)估的關(guān)閉Closing of risk

42、assessment5.8.1 風(fēng)險(xiǎn)控制方式實(shí)施結(jié)束后，風(fēng)險(xiǎn)管理小組組長(zhǎng)根據(jù)風(fēng)險(xiǎn)控制實(shí)施計(jì)劃實(shí)施的結(jié)果，填寫質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)： G04. 016- R1）第三部分內(nèi)容：風(fēng)險(xiǎn)控制執(zhí)行完畢后的風(fēng)險(xiǎn)再評(píng)估，對(duì)控制后的風(fēng)險(xiǎn)項(xiàng)目按5.5項(xiàng)重新進(jìn)行風(fēng)險(xiǎn)評(píng)估，以確定風(fēng)險(xiǎn)是否消除或降低風(fēng)險(xiǎn)至可接受的程度。At the end of execution of risk control protocol, according to the outputs of risk control, the leader of risk management team fills out the third part o

43、f Quality Risk Assessment Sheet (No,: G04. 016- R 1), Risk Reassessment, to reassess the risk as specified in article 5.5 and to determine if the risk is eliminated or reduced to an acceptable level.5.8.2 風(fēng)險(xiǎn)控制執(zhí)行完畢后的風(fēng)險(xiǎn)再評(píng)估內(nèi)容應(yīng)包括但不限于以下內(nèi)容：控制方式實(shí)施后的風(fēng)險(xiǎn)結(jié)果、實(shí)施風(fēng)險(xiǎn)控制方式前后的風(fēng)險(xiǎn)對(duì)比、實(shí)施結(jié)論等。Risk reassessment includes but

44、is not limited to outputs of risk controls, comparison between the risk before and after execution of risk controls, conclusion, etc.5.8.3質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04. 016- R 1）第三部分內(nèi)容交相關(guān)部門會(huì)審，如果結(jié)論經(jīng)會(huì)審確認(rèn)風(fēng)險(xiǎn)已經(jīng)消除或降低至可接受程度的，則接受風(fēng)險(xiǎn)，由QP 關(guān)閉風(fēng)險(xiǎn)管理程序；如果結(jié)論經(jīng)會(huì)審確認(rèn)風(fēng)險(xiǎn)沒有消除或降低至可接受的程度，拒絕風(fēng)險(xiǎn)，按照5.5 的程序，重新啟動(dòng)風(fēng)險(xiǎn)管理程序，重新啟動(dòng)風(fēng)險(xiǎn)管理程序仍沿用原來的編號(hào)，但需在編號(hào)后加

45、R×，×代表一位流水號(hào)。舉例：QRA11-07-01R1，表示編號(hào)為QRA11-07-01的風(fēng)險(xiǎn)評(píng)估重新進(jìn)行了1次評(píng)估。標(biāo) 題：版 本：第一版頁 號(hào)： 010/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGRelevant departments review the third part ofQuality Risk Assessment Sheet (No,: G04. 016- R1). If the re

46、viewcome to a conclusion that the risk is eliminated or reduced to an acceptable level, the risk will be accepted and the Qualified Person close the risk management process; otherwise, the risk management process shall be initiated again as specified in article 5.5. Adding RX at the end of the origi

47、nal QRA number as the QRA number of quality risk re-assessment process, X represent serial number. For example: QRA11-07-01 R1, representing one re-assessment of the quality risk assessment which numbered QRA11-07-01.5.8.4質(zhì)量風(fēng)險(xiǎn)評(píng)估表 （編號(hào)： G04. 016- R1）第三部分內(nèi)容完成后，作為最終風(fēng)險(xiǎn)評(píng)估驗(yàn)收的標(biāo)準(zhǔn)之一，來判斷風(fēng)險(xiǎn)評(píng)估是否最終完成。The content

48、of the third part ofQuality Risk Assessment Sheet (No,: G04. 016- R 1) is utilized to justify whether arisk assessment process is finished.5.9 檔案存儲(chǔ)Archival and Storage完成的質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04. 016- R1）、質(zhì)量風(fēng)險(xiǎn)管理記錄（編號(hào)： G04. 016- R2）由質(zhì)量管理部文件 QA 歸檔。Quality Risk Assessment Sheet (No,: G04. 016- R1) and Quality Ri

49、sk Management Record(No,: G04. 016- R2) arearchived by QA personnel in charge of documentation.5.10 質(zhì)量風(fēng)險(xiǎn)回顧Quality risk review每年在年度回顧中對(duì)質(zhì)量風(fēng)險(xiǎn)進(jìn)行回顧。Quality risks are reviewed annually during product review process.6. 培訓(xùn)Training6.1 培訓(xùn)對(duì)象：公司各部門（財(cái)務(wù)部除外）Trianee: all Gosun functional units except Financial Depa

50、rtment.6.2 培訓(xùn)時(shí)間： 1小時(shí)Training duration: an hour7. 附錄 Appendices附錄 1質(zhì)量風(fēng)險(xiǎn)評(píng)估表編號(hào)： G04. 016- R1Appendix 1 Quality risk assessment sheetNo.: G04. 016- R 1附錄 2質(zhì)量風(fēng)險(xiǎn)管理記錄編號(hào)： G04. 016- R2標(biāo) 題：版 本：第一版頁 號(hào)： 011/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version ：01Page ：Title:編號(hào) Document number ：Quality Risk Management ProcedureQ/GSG04. 016-11ZGAppendix 2 Quality risk management recordNo.