纠正措施与预防措施处理规程翻译

1 目的

为规范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进，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 behavior generated in the GMP, and meet the drug production in line with regulations and industry standards, and reduce product defect rate and the probability of the deviation occurrence, and realize the continuous improvement of the quality management system, we specially formulated corrective measures and prevention measures (Corrective Action & Preventive Action, hereinafter referred to as CAPA) management program.

2 适用范围

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 to all kinds of (potential) formulation, implementation and closed-loop confirmation which do not meet the CAPA in the GMP

2.2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等相关记录中体现。

That can take immediate emergency measures to solve the 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 once should 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 executive departments staff, CAPA quality information administrator, site QA, QA competent, Minister of quality management, Quality attorney

4 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 expectations, such as regulations, industry standards, company documents requirements.

潜在不符合：存在于事物内部尚未显露出来的、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 existing within the thing has not been revealed, probable or imminent can not meet the requirements of the situation had adverse trends, such as the quality of products, the potential impact of the risk assessment to identify.

应急措施：为避免已经发生的（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, 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 eliminate the 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 eliminate the 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、药监部门吊销生产许可证、收回GMP证书及批件等后果，关系到患者的生命安全、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 recall, a major customer complaints 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 company's 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，导致或可能导致产品内、外在质量受到某种程度的影响，超出内控质量标准，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 external quality impact beyond the internal quality control standards, there is 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范围，属于SOP符合性问题（即是否严格按SOP执行）、适用性问题（即SOP内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认证检查条款中的一般缺陷。

Sure you do not belong to these two ranges, belongs SOP compliance 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, inspectionafter 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 examination.

4.2 （潜在）不符合信息来源

(Potential) noncomformities with the sources of information

4.2.1 公司内部质量检查发现的（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；

External 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 complain of product defects, product recall information; (Potential) does not comply 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 comply 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；

-QC abnormal test results in the raw materials, auxiliary

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在产品年度回顾分析报告中提出的（潜在）不符合信息；

The-QA Products Annual Review analysis report (potential) does

not comply with the information;

—变更过程中发现的（潜在）不符合信息；

- (Potential) does not comply 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

comply with the information;

—文件评审过程中发现的（潜在）不符合信息；

- (Potential) does not comply 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

comply 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、产品关键工艺控制项目、参数呈趋势性变化；

Found in the production process (potential) does not comply 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, use, refunding, the (potential) does not comply 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 comply 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 comply with the 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、

物料信息反馈单、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

回顾分析报告、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 Approval Form excessive material information feedback single laboratory survey report of abnormal test results, the self-test report, customer complaint handling single verification report, stay kindobservation report, the stability of the inspection report, annual retrospective analysis reports, inspection reports of the third-party certification, company-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, executed 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 execution requirements, QA competent 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、相关方电话反馈

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

例的内部排查，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后30分钟内向质管部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 comply with the sources of information: as important issues to major market quality case internal investigation, no one can (potentially)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内填写好《纠正措施

与预防措施处理单》内容包括：

—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、姓名）、时

间（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 competent 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, 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信息管理员处进行编号，编号方式为：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。电子台账的内容包括（潜在）不符合来源、识别编号、（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 completed the transfer of "corrective and preventive measures to deal with single to the quality control department CAPA administrator ID No.: CAPA + Year (four digits) + serial number (three digitsThe), CAPA2011003. Establish CAPA's 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 the description, category, investigation of root cause, corrective action, preventive measures, the completion of the case, effectively assess whether the closed-loop and closed-loop time.

4.3.5 CAPA信息管理员将CAPA编号反馈现场QA，由现场QA将已编号的《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。具体内容包括纠正措施、预防措施、每项措施的责任人及完成

期限

CAPA Information Manager 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 comply with the departments involved to prepare the first draft of the implementation measures. Specific corrective measures, preventive measures, each measure of responsibility and deadlines

4.3.6 涉及部门在一个工作日内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内容进行初步审核，确认措施

的有效性和可行性，并给予涉及部门意见反馈。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，复审填写内容并确定属于不

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 first 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 department 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 department heads category (critical, important, general) clearly does not comply with the (potential) related to the sector and specified flow mainly related departments to the quality of the Minister to sign the final comments.

4.3.7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，调查人调查结束应形成（潜在）不符合调查报告附

入本报告中。调查内容应包括：

Support for follow-up treatment for non-program files (potential) does not comply, 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 explicitly specified investigation, the end of the survey period, the survey investigationIt should be the formation of the (potential) does not comply 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、供应商、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内容，附入《纠正措施与预防措施处理单》。

- Involved in issues 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, annexed to the"corrective measures and preventive measures to deal with a single.

—对收集的数据、信息进行分析，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 analysis to determine the possible causes: associated excluded 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: 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 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.

—若因某些信息需要进行验证、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一附入《纠正措施与预防措施处理单》中；

- Because some of the information needed to verify and test third-party identification, according to the actual situation, investigators are required to QA competent to make a written Deferral of investigation information application, the written material as one of the certificates annexed to corrective action and preventive 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，采取措施停止相关批次的放行，直至调查确认

与之无关后方可放行。

- If the(potential)does not comply with discovery and designated

investigating officers found in the survey do not meet the

(potential) related products may be batch associated with major quality problems, you must immediately notify the Minister of

quality control, quality attorney to take measures to stop the release of the relevant batch until investigations confirm

irrelevant before release.

4.3.8 关键的（潜在）不符合在二个工作日内、重要的（潜在）不符合在三

个工作日内、一般的（潜在）不符合可在三个工作日内，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。

Key (potential)does not comply within two working days, it is important (potential)does not comply within three working days, the(potential)does not comply within three working days, CAPA initial consultation departments to fill CAPA opinion, the

electronic version is sent to the administrator of the CAPA

quality of information.

4.4 CAPA措施的确定CAPA measures to determine

4.4.1 若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

进行讨论并最终达成一致意见后，原则上两个工作日内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

competent CAPA measures exist imperfect, defective, and the

occurrence of departments to discuss and eventually reached a consensus, the principle two working days QA in charge should in corrective action and preventive action processing single

"re-improve CAPA views.

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 generally 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 质管部部长、质量授权人对上述调查分析过程和提出的措施进行审

核，对CAPA进行最终批准，批准的意见作为CAPA的终审执行意见。

Quality Management Minister, the quality authorized in the

analysis process and the measures proposed in the above survey conducted our audit CAPA final approval, approval of the advice as a CAPA's of Final Appeal execution opinions.

4.4.5 指定的主要涉及部门负责将已批准的《纠正措施与预防措施处理单》

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 specified department is responsible for the

approval of corrective actions and preventive measures to deal with single the original handed CAPA specified acceptance of CAPA

the specified acceptance people responsible for the distribution

to the person in charge of the relevant executive departments.

4.5 CAPA措施的执行和确认CAPA implementation of the measures and

confirm

4.5.1 CAPA终审意见执行部门责任人按期限逐条落实批准的措施，若存在特

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 comments execution department responsible person by one period of the implementation of the approved measures, if there are special reasons can not be completed in a timely fashion, you need to QA QA competent given deadline issued by sufficient material to prove clear follow-up to the completion of measures and deadlinesCAPA implementation process, all

changes 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内，填写《纠正措施与预防措施处理单》中意见执行情况确认的相关信息，确认该措施已执行完毕；

4.5.3 若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有权对相关部门进行通报。

CAPA the final comments execution department is on schedule to complete the appropriate measures according to the site, notify the designated acceptance acceptance. Specified acceptance not received due notice, is responsible for the duration of the scene based on the completion of the approved corrective measures and preventive measures to deal with single"acceptance. Acceptance rationality,effectiveness and adequacy of acceptance,

specified acceptance in not more than within one working day

after the date of completion of specified, including the

implementation of views views on the implementation of

completing corrective and preventive measures to deal with

single confirmed relevant information, confirmed that the

measures have been completed;

4.5.4 在所有CAPA意见已执行结束并确认之后，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

转至质管部部长批准闭环，若CAPA执行结果存在合理性、有效性和充

分性问题，QA主管在《纠正措施与预防措施处理单》中签署是否重新

执行CAPA的意见，并汇报质管部部长。Specify the

main departments involved in all CAPA comments have been after

the end of the execution and confirm the "corrective actions and

preventive measures to deal with the single" and submissions,

cross-QA competent assessment of the implementation of the

effect of flow to the approval of the Minister of the Department

of quality control closed loop CAPA execution resultsrationality, effectiveness and adequacy of QA supervisor "corrective and

preventive measures to deal with single sign whether the

re-implementation of the CAPA views and report on quality control, Minister.

4.5.5 CAPA执行的合理性、有效性和充分性可通过是否重复发生来判断，同

一CAPA提出超过三次以上，需发生部门负责人亲自进行调查。CAPA

implementation rationality, effectiveness and adequacy to

determine whether recurring, the same CAPA more than three times

more than the occurrence of the department responsible for the

investigation personally.

4.6 《纠正措施与预防措施处理单》的存档Corrective actions and

preventive measures to deal with single archive

4.6.1 《纠正措施与预防措施处理单》原件由质量管理部负责存档，保存期

限10年；

Corrective actions and preventive measures to deal with single

"Original Quality Management Department is responsible for

archiving and shelf life of10years;

4.6.2 对于SOP程序文件中无后续相应CAPA执行要求的情况，由CAPA信息

管理员将《纠正措施与预防措施处理单》复印件附入相应的信息源流

转单据、报告中，原件仍在质量管理部存档。

"Corrective action and preventive action by CAPA information

administrator for the subsequent corresponding CAPA

implementation requirements of the SOP program files, handle

single copy of information source circulation documents annexed

to the report, is still in the original archive Quality

Management Department.

5 相关文件、记录和标签 Related Documents, Records and tags JL10064 纠正措施与预防措施处理单

Product fraction of management procedures