纠正措施与预防措施处理规程-翻译

1、. 1 目的为规GMP运行过程产生的潜在不符合的处理行为，使药品生产符合法规、行业标准规定，降低产品缺陷率及偏差发生的机率，实现质量管理体系的持续改良，特制定纠正措施与预防措施Corrective Action & Preventive Action，以下简称CAPA的管理程序。To regulate the incongruent processing behaviorgenerated in the GMP, and meet the drug production in line with regulations and industry standards, and reduce pr

2、oduct defect rate and the probability of the deviationoccurrence, and realize the continuous improvement of the quality management system, we specially formulated corrective measures and preventionmeasures (Corrective Action & Preventive Action, hereinafter referred to as CAPA) management program.2

3、适用围2.1适用于药品GMP运行过程产生的各类潜在不符合的CAPA制定、实施及闭环确认。Applies toall kinds of (potential) formulation, implementation and closed-loop confirmation which do not meet the CAPA in the GMP2.2在生产质量活动中，能够立即采取应急措施解决问题且相关批次产品质量无影响，可以不执行该程序。但出现一次以上的除外，应在BPR等相关记录中表达。That can take immediate emergency measures to solve th

4、e problem and is not related to the batch product quality in production quality activities, we can not perform the procedure. But the case that appears more than onceshould be reflected in BPR and other related records.3 责任人CAPA相关的执行部门人员、CAPA质量信息管理员、现场QA、QA主管、质量管理部部长、质量受权人CAPA e*ecutive departments

5、staff, CAPA quality information administrator, site QA, QA petent, Minister of quality management, Quality attorney4 工作程序4.1 相关定义不符合：未满足要求。“要求是指明示的、通常隐含的或必须履行的需求或期望，如法规、行业标准要求，公司文件要求等。Nonconformities: not meeting requirements. Requirements stated, generally implied or obligatory requirements or e*pe

6、ctations, such as regulations, industry standards, pany documents requirements.潜在不符合：存在于事物部尚未显露出来的、有可能或即将不能满足要求的情况，如产品质量呈现不良趋势、经风险评估识别的潜在影响。Potential nonconformities: that e*isting within the thing has not been revealed, probable or imminent can not meet the requirements of the situation had adverse

7、 trends, such as the quality of products, the potential impact of the risk assessment to identify.应急措施：为防止已经发生的潜在不符合继续恶化或对相关设备、物料、产品产生进一步负面影响而采取的紧急处理措施。Emergency measures: To avoid the (potential)nonconformities that has occurred to deteriorate or produce further negative impact on related equipment

8、, materials, products,and take emergency measures.纠正措施CA：为消除已发现的不符合或其他不期望情况的原因所采取的措施，以防止问题的再次发生。Corrective Action (CA): To eliminatethe nonconformities that has been found or the cause of other undesirable situation, and take the measures to prevent the problem from happening again.预防措施PA：为消除潜在不符合或其

9、它潜在不期望情况的原因所采取的措施，防止问题的发生。The precautions (PA): To eliminatethe nonconformities that has been found or the cause of other undesirable situation, and take the measures to prevent the problem from happening.潜在不符合分类： The classification of (potential) nonconformities:关键 - Key确认违反法定工艺、超出国家法定质量标准或违反药品生产相关

10、法规规定，将会造成产品整批报废、产品召回、重大客户投诉、药监部门撤消生产许可证、收回GMP证书及批件等后果，关系到患者的生命平安、企业的品牌形象和产品的市场影响。Verify that the violation of the statutory process beyond national statutory quality standards or violation of pharmaceutical production and related regulations, the entire batch will cause product obsolescence, product

11、 recall, a major customer plaints and Drug Administration shall revoke the production license, recover GMP certificates and documents issued consequencesrelated to the lives and safety of the patients, the market impact of the panys brand image and products.重要- Important关键性物料、设备、厂房、工艺、介质、环境发生偏移，导致或可

12、能导致产品、外在质量受到*种程度的影响，超出控质量标准，存在导致或可能将会导致产品返工、重新处理等质量风险、违反GMP、工艺的事件，直接影响企业的正常运转。Critical materials, equipment, plant, technology, media, environmental shift, caused or may cause the product to be subject to some degree of e*ternal quality impact beyond the internal quality control standards, there is

13、cause or likely will lead to product rework, re-processing and quality risk, in violation of the GMP, craft events directly affect the normal operation of the enterprise.一般- General经确认不属于上述两种围，属于SOP符合性问题即是否严格按SOP执行、适用性问题即SOP容是否很适用于实际操作及有效性问题即按照SOP要求执行，检查实施后的效果是否很有效等，不会导致产品返工和重新处理，但存在违反GMP要求且属于GMP认证检

14、查条款中的一般缺陷。Sure you do not belong to these two ranges, belongs SOP pliance issues (ie, whether strictly performed according to SOP) applicability (ie, the the SOP content is very applicable in practice) and the effectiveness of (implementation requirements in accordance with SOP enforcement, inspecti

15、onafter effect is very effective) will not cause the product to rework and re-processing, but a violation of the requirements of GMP and belong to the defects in the general terms of the GMP certification e*amination.4.2 潜在不符合信息来源(Potential)nonformities with the sources of information4.2.1 公司部质量检查发现

16、的潜在不符合的信息；Internal quality check found the information does not meet the (potential);4.2.2 外部质量检查发现的潜在不符合的信息；E*ternal quality check found that the information does not meet the (potential);4.2.3 顾客、相关方投诉产品缺陷、产品召回的相关信息；Customers plain of product defects, product recall information;(Potential) does no

17、t ply with the information found in the 4.2.4 质量管理过程中发现的潜在不符合的信息；Quality management process;QA或车间在日常GMP检查过程中发现的潜在不符合的信息；-QA or workshop (potential) does not ply with the information found in the day-to-day GMP inspection process;QC在原料、辅料、包装材料、中间产品、成品等检测结果异常，实验室留样观察、稳定性考察结果异常或产品质量呈不良趋势性变化或潜在不符合的信息；-Q

18、C abnormal test results in the raw materials, au*iliary materials, packaging materials, intermediate products and finished products, laboratory observation, to stay kind the abnormal stability test results or product quality was bad trend changes or potential nonconformities information;QA在产品年度回忆分析报

19、告中提出的潜在不符合信息；The-QA Products Annual Review analysis report (potential) does not ply with the information;变更过程中发现的潜在不符合信息；- (Potential) does not ply with the information found in the change process;验证过程中发现的潜在不符合信息；- Found in the validation process of the (potential) does not ply with the information;

20、文件评审过程中发现的潜在不符合信息；- (Potential) does not ply with the information found in the document review process;经质量风险评估发现的潜在不符合信息；- Quality risk assessment found that the (potential) does not ply with the information;4.2.5 生产管理过程中发现的潜在不符合信息，包括生产过程、生产介质、设备发生偏差、产品关键工艺控制工程、参数呈趋势性变化；Found in the production proce

21、ss (potential) does not ply with the information, including the production process, production, media, equipment deviations occur, the product key process control project parameters showed a trend of change;4.2.6 物料仓储、运输、发放、使用、退库、销毁等管理过程中发现的潜在不符合信息；Materials storage, transportation, distribution, us

22、e, refunding, the (potential) does not ply with the information found in the destruction process;4.2.7 其它情况发现的潜在不符合信息。Other conditions found in the (potential) does not ply with the information given.4.3 对于4.2中“潜在不符合信息来源，分别按以下方式启动CAPA程序：Start the CAPA program for 4.2 (potential) does not ply with th

23、e sources of information, respectively, in the following manner:4.3.1 有文件支持的潜在不符合信息源，如偏差处理单、变更审批表、物料信息反应单、实验室超标、超常检验结果调查报告、自检报告、客户投诉处理单、验证报告、留样观察报告、稳定性考察报告、产品年度回忆分析报告、第三方认证检查报告、公司级会议纪要要求等：File support does not meet the (potential) source of information, such as deviation handling single change and A

24、pproval Form e*cessive material information feedback single laboratory survey report of abnormal test results, the self-test report, customer plaint handling single verification report, stay kindobservation report, the stability of the inspection report, annual retrospective analysis reports, inspec

25、tion reports of the third-party certification, pany-level meeting minutes requirements:对SOP程序文件中规定了具体CAPA执行要求的情况，按照程序文件执行，如偏差处理；- Perform the requested provisions specific CAPA SOP program files, e*ecuted in accordance with the program files, such as deviation handling;对SOP程序文件中后续未规定或无相应文件支持CAPA执行要求

26、的情况，QA主管指定人员启动CAPA程序。- On the the SOP program files in the follow-up not specified or no corresponding file support CAPA e*ecution requirements, QA petent the designated personnel start CAPA program.4.3.2 对于无文件支持的潜在不符合信息源：如顾客、相关方反应产品质量信息，QA或其他人员现场检查到的重要问题，市场重大质量案例的部排查，任何人均可以是潜在不符合信息发现人，由信息源发现者第一人在发现

27、后30分钟向质管部QA主管报告，启动CAPA程序；Customers, stakeholders Tel feedback product quality information, QA or other personnel at the scene to check for file support (potential) does not ply with the sources of information: as important issues to major market quality case internal investigation, no one can (poten

28、tially)does not meet the information found, by information sources discoverer of the first people in the quality control department within 30 minutes after the discovery of the QA supervisor, start the CAPA program;4.3.3 经QA主管确认后，发现人或提出人员在一个小时填写好“纠正措施与预防措施处理单“容包括：发生部门，提出人，日期；实际存在的潜在不符合的描述，包含：人物职位、时间

29、日期、时间、阶段、班次等、地点场所、设施、特殊的操作环境、起因、过程或发生的现象、导致的结果、目前的状态产品、物料、仪器等，已经采取的应急措施。Confirmed by the QA petent person or proposed fill within an hour corrective actions and preventive measures to deal with single include:- Departments, date;- The actual presence of the (potential) does not meet the description,

30、 including: character (Jobs, name), time (date, time, phase, trips, etc.), location (premises, facilities, special operating environment), the causes, process, or phenomenon, the result of the current state (products, materials, equipment, etc.), have taken emergency measures.4.3.4 发现人或提出人员填写完毕后，将“纠

31、正措施与预防措施处理单“流转至质管部CAPA信息管理员处进展，方式为：CAPA+年份四位数+流水号三位数，如CAPA2011003。建立CAPA的电子台账。电子台账已使用分散型系统。电子台账的容包括潜在不符合来源、识别、潜在不符合描述、类别、根本原因调查、纠正措施、预防措施、完成情况、有效评估、是否闭环以及闭环时间。Found or proposed staff pleted the transfer of corrective and preventive measures to deal with single to the quality control department CAPA

32、administrator ID No.: CAPA + Year (four digits) + serial number (three digitsThe), CAPA2011003. Establish CAPAs electronic ledger. The electronic ledger decentralized system. The contents of the electronic ledger does not meet the (potential) source identification number (potential) does not meet th

33、e description, category, investigation of root cause, corrective action, preventive measures, the pletion of the case, effectively assess whether the closed-loop and closed-loop time.4.3.5 CAPA信息管理员将CAPA反应现场QA，由现场QA将已的“纠正措施与预防措施处理单“，发至潜在不符合涉及部门拟定执行措施初稿。具体容包括纠正措施、预防措施、每项措施的责任人及完成期限CAPA Information Ma

34、nager CAPA No. feedback site QA, numbered by the on-site QA corrective measures and preventive measures to deal with single hair to (potential) does not ply with the departments involved to prepare the first draft of the implementation measures. Specific corrective measures, preventive measures, eac

35、h measure of responsibility and deadlines4.3.6 涉及部门在一个工作日将执行措施初稿流转至现场QA处，现场QA在收到CAPA初稿后第二个工作日对填写容进展初步审核，确认措施的有效性和可行性，并给予涉及部门意见反应。涉及部门按意见完善措施，交现场QA签字确认后流转至QA主管，复审填写容并确定属于不符合还是潜在不符合，必要时与质管部部长及相关部门负责人讨论潜在不符合的类别关键、重要、一般，明确与潜在不符合相关的部门，并指定由主要涉及部门流转至质量部部长签署终审意见。Departments involved the circulation of the f

36、irst draft of the implementation of measures within one business day to the scene QA at site QA in the second working day after receipt of CAPA draft filled out a preliminary audit to confirm the effectiveness and feasibility of the measures and give the involved departmentFeedback. Involved departm

37、ent views perfect measures, cross-site QA signature confirmation circulation to QA supervisor, fill in the content reviewed and determined to belong to does not meet or potential nonconformity, if necessary, to discuss the (potential) does not meet with the the quality tube Minister and the relevant

38、 department heads category (critical, important, general) clearly does not ply with the (potential) related to the sector and specified flow mainly related departments to the quality of the Minister to sign the final ments.对于无程序文件支持后续处理的潜在不符合，因原因尚不明确需要开展调查的，QA主管应在“纠正措施与预防措施处理单“中明确指定调查人、调查期限，调查人调查完毕应

39、形成潜在不符合调查报告附入本报告中。调查容应包括：Support for follow-up treatment for non-program files (potential) does not ply, the reason is not yet clear need to carry out the investigation, QA managers should be in a corrective and preventive measures to deal with single e*plicitly specified investigation, the end of t

40、he survey period, the survey investigationIt should be the formation of the (potential) does not ply with the investigation report is attached to this report. The investigation should include:收集涉及问题相关的数据、信息，如：设备、人员、工艺、设计、文件、供给商、生产过程、培训、软件、财务、检验数据、文献资料等，以附件形式记录调查容，附入“纠正措施与预防措施处理单“。- Involved in issue

41、s related to data and information collected, such as: equipment, personnel, technology, design, document, suppliers, production process, training, software, financial test data, literature, etc., to record survey the contents of an attachment, anne*ed to thecorrective measures and preventive measure

42、s to deal with a single.对收集的数据、信息进展分析，可通过建立分析小组，利用头脑风暴和因果图标等工具。- The analysis of the collected data, information, and through the establishment of the Analysis Group, using tools such as brainstorming and causal icon.通过调查分析，确定可能的原因：从列出的有关事实、关联中排除与资料信息不符的原因，确定所有可能的根本原因。- Through the investigation and

43、 analysis to determine the possible causes: associated e*cluded from the list of the relevant facts, reasons that are inconsistent with the data and information, to determine the root cause of all the possible.挑选根本原因：可根据人、机、料、法、环等关联变化、相应的资料数据，在所有的可能原因中，挑选与资料最相符的根本原因。- The selection of the root cause

44、: the associated changes according to human, machine, material, method, ring, Data, and in all the possible reasons, the selection of data are most consistent with the root cause.核实根本原因：核实最有可能的根本原因和支持结论的资料，剔除所有与资料信息不符的可能原因。- To verify the root cause: to verify the most likely root cause and support

45、the conclusions of the data, remove all data and information may be inconsistent reasons.即使没有确定的根本原因，也应记录原因分析过程中所有活动和得出的结论。- Even determine the root cause of all activities cause analysis process and the conclusions should be recorded.假设因*些信息需要进展验证、试验、第三方鉴定等情况，根据实际情况，调查人需向QA主管提出书面推迟调查信息申请，该书面材料作为凭证之

46、一附入“纠正措施与预防措施处理单“中；- Becausesome of the informationneededtoverifyandtestthird-partyidentification, according to the actual situation, investigatorsare required toQApetenttomake a writtenDeferral of investigationinformationapplication, thewrittenmaterialasone of the certificatesanne*ed tocorrective a

47、ctionandpreventive measureshandle single in;如果潜在不符合发现人和指定调查人员在调查中发现潜在不符合可能与相关产品批次有关联且有重大质量隐患，则必须立即通知质管部部长、质量受权人，采取措施停顿相关批次的放行，直至调查确认与之无关前方可放行。- Ifthe(potential)does not ply withdiscoveryand designatedinvestigating officersfoundinthe surveydo not meet the(potential) related productsmaybebatchassociat

48、ed withmajor qualityproblems, you mustimmediately notifytheMinisterofquality control, quality attorneyto takemeasures tostopthe releaseoftherelevantbatchuntilinvestigationsconfirmirrelevantbefore release.4.3.8 关键的潜在不符合在二个工作日、重要的潜在不符合在三个工作日、一般的潜在不符合可在三个工作日，CAPA初步意见征询部门填写好CAPA意见，将电子版发送至CAPA质量信息管理员处。Ke

49、y (potential)does not plywithintwo workingdays, it is important (potential)does not plywithin three working days, the(potential)does not plywithin three working days, CAPA initialconsultationdepartmentsto fillCAPA opinion, theelectronic versionissent totheadministratoroftheCAPAquality ofinformation.

50、4.4 CAPA措施确实定CAPA measures to determine4.4.1 假设QA主管认为CAPA措施存在不完善、有缺陷的情况，应与发生部门进展讨论并最终达成一致意见后，原则上两个工作日QA主管应在“纠正措施与预防措施处理单“中重新完善CAPA意见。QA petentCAPAmeasurese*istimperfect, defective, and the occurrence ofdepartmentstodiscussand eventuallyreacheda consensus, theprincipletwoworking daysQAin chargeshould

51、incorrective actionand preventive actionprocessingsinglere-improve CAPAviews.4.4.2 每项潜在不符合的CAPA均应明确责任人、具体措施、完成期限、验收人、验收附件等信息，验收人一般为现场QA人员；Each (potential) does not meet the CAPA should be clear lines of responsibility, specific measures, deadlines, acceptance, and acceptance attachments acceptance g

52、enerally live QA personnel;4.4.3 CAPA措施的信息录入完毕后，指定的主要涉及部门将“纠正措施与预防措施处理单“流转至质管部部长、质量授权人处。CAPA measures of information input after, mainly related to the specified department corrective and preventive measures to deal with single flow to the Minister of quality control, quality, authorized at.4.4.4 质管

53、部部长、质量授权人对上述调查分析过程和提出的措施进展审核，对CAPA进展最终批准，批准的意见作为CAPA的终审执行意见。Quality Management Minister, thequalityauthorized intheanalysisprocessandthe measures proposed inthe above surveyconducted our auditCAPAfinal approval, approval oftheadvice as aCAPAs ofFinal Appeale*ecutionopinions. 指定的主要涉及部门负责将已批准的“纠正措施与预防

54、措施处理单“原件上交CAPA指定验收人，CAPA指定验收人负责分发至相关执行部门负责人。 Mainly related to the specifieddepartment is responsible fortheapprovalofcorrective actionsandpreventivemeasures to deal withsingletheoriginalhandedCAPAspecifiedacceptanceofCAPAthe specifiedacceptancepeopleresponsible for the distributiontotheperson in ch

55、argeoftherelevant e*ecutive departments.4.5 CAPA措施的执行和确认CAPA implementation of the measures and confirm4.5.1 CAPA终审意见执行部门责任人按期限逐条落实批准的措施，假设存在特殊原因不能及时完成，需在QA主管给出的期限前向QA出具充分的材料予以证明，明确后续的完成措施及完成期限，在CAPA实施过程中所有变更应予以记录，相关材料附入“纠正措施与预防措施处理单“中； CAPA the final ments e*ecution department responsible person by

56、 one period of the implementation of the approved measures, if there are special reasons can not be pleted in a timely fashion, you need to QA QA petent given deadline issued by sufficient material to prove clear follow-up to the pletion of measures and deadlinesCAPA implementation process, all chan

57、ges should be recorded, and related materials are attached into the corrective measures and preventive measures to deal with the single ;4.5.2 CAPA终审意见执行部门按期完成相应的措施后，通知指定验收人根据现场验收。指定验收人到期未接到通知时，负责根据已批准的“纠正措施与预防措施处理单“的完成期限现场验收。验收应包括意见执行的合理性、有效性和充分性，验收合格后，指定验收人员在不超过指定完成日期后一个工作日，填写“纠正措施与预防措施处理单“中意见执行情况

58、确认的相关信息，确认该措施已执行完毕；4.5.3 假设因客观原因无法执行完毕，责任人应提交充分的评估材料，经部门领导审核、质管部部长批准，同意中止、暂停或重新启动CAPA程序，所提交的材料应附入本报告中；因主观原因未执行或执行不全面、有错误的情况，指定验收人应书面报告QA主管，QA有权对相关部门进展通报。 CAPA thefinal mentse*ecutiondepartmentison schedule to pletethe appropriatemeasuresaccording to the site, notify the designatedacceptanceacceptanc

59、e. Specifiedacceptancenot receivedduenotice, isresponsiblefortheduration ofthe scenebased onthepletionoftheapprovedcorrectivemeasuresandpreventivemeasures todeal withsingleacceptance. Acceptancerationality,effectiveness and adequacy ofacceptance, specifiedacceptanceinnot more thanwithin one working

60、dayafterthedate of pletion ofspecified, including theimplementationofviewsviews onthe implementation ofpletingcorrective and preventivemeasures to deal withsingleconfirmedrelevantinformation, confirmedthatthemeasureshave beenpleted;4.5.4 在所有CAPA意见已执行完毕并确认之后，指定主要涉及部门将“纠正措施与预防措施处理单“和提交材料，交QA主管评估执行效果后流