CGMP文件风险分析格式SOP

1、CGMP文件 风险分析格式 SOP文件题目Docume nt Title风险分析的格式SOPSOP - Format of risk an alysis文件编号Document Code文件版本号Version Code00文件种类Category of Document治理标准Management standard发放部门Department of IssueQAf人员 Person 类不 Category-姓名/职位Name /Position签名Signature日期Date编写人Compiled by审核人Checked by批准人Approved by文件分发部门/编号：（）Depa

2、rtment of document distributed/Code:序号Serial No.部门名称Department Name份数Copies负责人Manager12345678文件变更历史：History of document changing:版本号变更日期变更内容摘要Version CodeChanging DateAbstract of Changing Contents002011建立文件File foundation1 目的 Aim 规范风险分析的格式 , 和公司内部按照 FMEA (失败模式阻碍分析) 方法实施风险分析的方法，最终降低产品的质量风险。To standar

3、dize the format of risk analysis and methods to carry out r isk analysis according to FMEA (Failed Mode Effects Analysis) in interna l enterprise, finally to reduce the quality risk of product.2 范畴 Scope 在进行工艺验证，设备确认时(包括生产工艺验证、灭菌工艺验证、 水制备工艺验证等)时，应按照 FMEA 方法对验证的过程进行风险分析； 在进行重大变更时或引入新的程序时，应按照需要进行风险分析。

4、During process validation and equipment qualification (including prod uction process validation, sterilisation process validation and water preparat ion validation , etc.),its necessary to do risk analysis to validation proce ss on the basis of FMEA ； When carrying through important change or in duc

5、ting new process, use risk analysis when needed.3 职责 Responsibility3.1 QA 部负责建立和更新本 SOPQA Department takes responsibility on establishing and updating thisSOP.3.2 各部门负责相应范畴内的风险分析。Every department take charge of risk analysis in corresponding areas.3.3 确认 /验证委员会负责监督验证 /确认时本程序的有效实施。详细内 容请见“确认 /验证委员会工作

6、描述”(编码：)。Qualification and validation committee sees to implement this process efficiently when supervising validation and qualification .Detailed content can be referred in “ Position-related job description - Qualification / Vali dation committee” (Code:).4 内容 Content本 SOP 的内容以 FMEA 记录表的形式来实施。Cont

7、ents of this SOP are implemented in the form of FMEA record tables.本 SOP 的内容需通过确认 /验证委员会或变更操纵委员会通过会议讨 论来进行实施 .在讨论会上，必须至少有一位生产技术部成员，一位质量保 证部成员和一位设备部成员参加。This SOP should be implemented after the discussion in the meetings of qualification and validation committee or changing control committee, and the

8、re should be a member of production technology department, a me mber of quality assurance department and a member of equipment depart ment present at least.4.1 错误 /关键参数的收集 Collection of wrong and key parameters 需要对所有过程或系统的所有操作 /功能参数进行测定，并将各操作项 目 /功能清晰的列在 FMEA 记录单中。确认 /验证委员会或变更操纵委员会 的所有在场成员都必须参与此项工作。

9、错误 /关键参数收集的基础是：能够 导致失败的关键参数或关键步骤的确认。关于每个确认的参数 /过程(在 F MEA 记录单上的参数处给出)，应详细评估其可能带来的潜在的失败的 阻碍(在 FMEA 记录单上的潜在风险处给出)。Its necessary to mensurate all operation and function parameters in all process or system, and list every operation item and function on FM EA record tables .All present members of qualifi

10、cation and validation com mittee or change control committee must take part in this task. The basis of collecting wrong and key parameters is that it s qualification of key parameters or key process which may lead to failure. Every confirmed p arameter or process (placed at Parameter on the record t

11、ables) should be given detailed evaluation on influence brought by possible and potential fa ilure (given at Potential Risk on FMEA record tables).4.2 潜在失败阻碍的确定 Confirmation of influence caused by potenti al failure可能通过确定合理的失败缘故来改善对失败所造成的阻碍的描述和评 估。在确定潜在失败所造成的阻碍和失败缘故时，要专门考虑对产品质量 造成的阻碍。It is posible t

12、o improve the describtion and evaluation to the effect c aused by failure through confirming reasonable failure reason. When maki ng sure the fluence of potential failure and failure causes, please pay part icular attention to fluence on product quality.4.3 潜在失败 /关键参数的评估 Evaluation on potential fail

13、ure and ke y parameters按照 FMEA 方法，在风险评估过程中，要对下面三个因素进行评估：-风险的发生频率可通过“失败的频率”要素(F)来确定。- “失败的严峻性”必须由确认 /验证委员会或变更操纵委员会来评 估，它也是风险评估的一个要素。- 还要通过评估“察觉失败的可能性”这一要素对风险进行评估。According to FMEA, in the process of risk evaluation, three factors below should be evaluated:-Risk occurrence can be confirmed by failure

14、frequency element (repr esented by F)-Failure graveness should be evaluated by qualification and validation committee or change control committee, and it s also one element of ri sk evaluation.-Risk should be evaluated from the element -possibility of aware fail ure.以各要素的值为1-5来表示。F值为1,表示发生失败的频率最小，F

15、值为5,表示发生失败的频率最大。同理， G=1，表示严峻性最小，G=5，表示严峻性最大。依此类推。在必要的情形下，委员会可对所有的风险因 素分不确定其评估数值。为了幸免委员会成员的意见不统一，建议依旧事 先确定评估等级标准，以便于风险的评估。范例格式如下表所述：风险分析参数：失败的频率(F)Risk analysis parameter: failure frequency (F)评估evaluation标准standard1专门低Extremely low2低Low3中等Medium4高High5专门高Extremely high风险分析参数：失败的严峻性(G)Risk analysis p

16、arameter: failure graveness (G)评估evaluation标准standard1专门低：失败不阻碍产品的质量Extremely low: Failure has no influence to product quality.2低：失败不阻碍产品的质量或以间接的方式对产品质量有专门小的阻碍Low: Failure has no influence or influent indirectly to product quality3中等：失败对产品质量有专门小的阻碍或只是间接阻碍。产品质量的下降 在某种程度上不阻碍产品放行。Medium: Failure has a

17、fraction of influences or just indirect ones. Quality decline doesn affect releasing products.4高：失败直截了当阻碍产品质量。产品的质量下降会阻碍产品放行。High:Failure affects product quality directly. Quality decline has impact on product release.5专门高：对法规或指导中涉及的方面应进行评估，以达到所要求的标准。Extremely high: It needed to evaluate the aspects

18、 involved in regulations or guidance to expected standard.风险因数：察觉失败的可能性(P)Risk factor: possibility of aware failure (P)评估evaluation标准standard5专门低：失败不可能被察觉，没有定期的检查，没有文件规定要进行符合 性研究。Extremely low: Failure can t be perceived, without regular check and documentation to do compliance research.4低：差不多的过程操纵检

19、查，失败不易于察觉。设备和仪器的技术性检查 仅仅是偶然进行。Low: It needs basic process control check and its not prone to failure.Just occasionally technical check on equipment and instruments.3中等：定期进行过程操纵检查或不连续的监测，失败易于察觉。Medium: It needs regular process control check or incontinuous monitoring and failure can be perceived.2高：采

20、取不同的方法进行监测，如工艺参数的监测，有专门大可能确定在 后续的生产过程中发生的失败。High: It takes various monitoring methods, such as: monitoring on process parameters; it is more likely to confirm failure in the following product process.1专门高：100%的监测，并可确定在后续的生产过程中发生的明显失败。Extremely high: It needs fully monitoring and can confirm obvious

21、failure in the following product process.重要讲明：请注意，在此表格中，评估等级是从“5”到“ 1”。Important note: please notice that evaluating grade is from 5 to 1.4.4 风险追踪Risk Pursue通过因素的等级评估和三个要素的乘积数，能够确定某一个阻碍因素 的风险评估值。因此，如果显现下列情形，就必须进行风险追踪：三个要素的乘积数大于“ 24”三个被评估的要素中，有一项大于或等于“4”。关于风险追踪，至少应考虑该项风险参数是否是与质量有关的。如果 有必要进行风险追踪，应提出解决

22、的措施或更进一步的调查研究的内容， 以排除可能发生的失败并实施下一步的研究。A risk evaluating value can be obtained from factor grade evaluation and products of three elements.Therefore, risk pursue must be carried through if the following cases happe n:-The product of three elements is greater than 24;-One of the three evaluated elemen

23、ts is greater than or equal to 4.Concerning on risk pursue, it should be take n into con sideratio n that whether the risk parameter is related to quality or not. If risk Pursue is n ecessary,advanee solving measures or make further to survey researching contents to get rid of contingent failure and

24、 go on next research.4.5 总结 conclusion风险分析以表格的形式加入在各相应的验证文件中，作为文件内容的 一部分。范例格式如下所示，Risk analysis is added to corresponding validation document in the fo rm of tables as a part of the document. Format example shows below:项目Item潜在的风险/ 错误Potential Risk/ Errors失败的频率Frequency ofFailure (F)失败的严峻性Gravity of

25、 Failure (G)察觉失败的可 能性Probability to detect Failure (P)风险评估Evaluation of Risk(F X G X P)风险的追踪*Pursue of Risk*项目1Item 1项目2Item 2项目3Item 34.6 风险同意评判Risk accept evaluation应在采取措施后再进行风险分析，以确定风险已降低至可同意水平内 (即三个要素的乘积数小于或等于“ 24”).同时应对有关的本来在可同意水 平内的风险再进行一次风险分析，以确定风险未有增加，仍旧在可同意水平 内.若依旧有风险项目超出操纵范畴，则应重点对该风险进行分析，提

26、出新的 改进操纵措施.直至该风险降低到可同意水平.风险评估的格式如下所示：Con duct risk an alysis after pursue measures to en sure risk has bee n declined to an acceptable level (that product of the three element is less t han or equal to 24). At the same time, con duct one more risk an alysis o n related and essentially acceptable ris

27、k to make sure that risk doesn t i ncrease and stay acceptable. If there still are risk items out of controllabl e range, focus on analysis on this risk and put forward new improving c ontrol measure until it falls to an acceptable level. The format of risk ev aluation is as following:项目Item潜在的风险 /错

28、误PotentialRisk/ Errors风险的 追踪Pursue of Risk失败的频率Frequency ofFailure (F)失败的严峻性 Gravity of Failure(G)察觉失败的 可能性Probability to detectFailure (P)风险评估Evaluation of Risk (F X GX P)风险同意评判Risk accept evaluation项目1Item 1项目2Item 2项目3Item 35 风险分析的记录Risk analysis record一样来讲，风险分析的进行通常和打算的改进措施合并在一起，因此 不必要另外编写一份风险分析文件，只需要在有关文件中附加风险分析的 记录。如在工艺验证主方案中，风险分析记录需要按照