1.目的Purpo
本文件规定企业纠正预防措施系统（CAPA）如何建立，通过对纠正措施的制订和实施进行有效的控制，消除产生问题的实际原因，防止再次发生不合格/不符合，以达到持续改进的目的。
This document defines how the company creates CAPA system and then effectively controls it by making and implementing corrective and active actions to eliminate the real reasons of problem, prevent against disqualification and non-compliance and reach the goal of continuous improvement.
2.适用范围Scope
本文件适用于全公司所有部门和场所对有关产品、过程及质量管理体系纠正和预防措施的控制。
This document applies to the control of corrective and preventive actions regarding products, process and quality management system .
3.职责Responsibility
3.1.责任部门为CAPA的发起人。发起人负责发起CAPA，填写CAPA来源，描述事件，识别根本原因，写出采取的纠正与预防措施，预计的时限，CAPA人员的姓名并获得责任部门负责人的批准。Res
ponsible department is the initiator of CAPA. Initiator is responsible to rai CAPA, write the source of CAPA, description of incident, Identify the root cau, write CAPA to be taken, write estimated timeline, write the responsible person’s name for CAPA completion and take approval from the head of the responsible department.
3.2.CAPA责任人负责CAPA的延期申请并在措施完成后通知QA。
Responsible person for CAPA completion is responsible to apply for extended timeline for CAPA completion. He is also responsible to notify QA after completion of action.万圣节英语
3.3.QA应发放CAPA编号并获取CAPA有效性相关信息，同时确定CAPA有效性的检查方法。另外，QA负责监督CAPA进程并告知其他部门CAPA的完成情况。最后，QA进行趋势分析并起草季度报告。QA shall give CAPA reference number and collect information related to effectiveness of CAPA. QA shall also decide the method of effectiveness check. QA is responsible to monitor the status of CAPA, Share CAPA status with other departments, perform trend analysis and prepare Quarterly report.
3.4.责任部门负责人应负责批准起草人制定的CAPA方案且批准CAPA的延期。
Responsible department Head is responsible to approve the proposal made by the initiator, approve the extended timeline for CAPA completion.
橙子怎么榨汁好喝3.5.QA经理负责批准预期的CAPA完成时限，验证CAPA完成时限确定的依据，检查CAPA的完成情况，审核相关文件，验证CAPA有效性，最终作出决定，是否关闭CAPA。若认为CAPA无效，QA经理可提出新的纠正预防措施。反之，若CAPA有效，则关闭CAPA。
QA Manager is responsible to approve the estimated timeline for completion of CAPA, authorize the extended timeline for CAPA completion after verification of justification, verify the CAPA completion and review the documents related to verification, verify the effectiveness of CAPA and take decision of CAPA cloout. If CAPA is not effective he can propo new CAPA or clo CAPA if CAPA is found to be effective.
4.定义Definition
纠正和预防措施：当非预期事件发生后，首先要采取措施防止事件的进一步进展，进而调查直接原因并采取措施予以纠正，这就是纠正措施的过程；再进一步调查原因，并采取措施防止其再次发生，这就是预防
烧衣节
措施的过程。
CAPA: once unexpected event happened, the first step is taking actions to prevent against deteriorat
ion and then investigating the direct reason and taking actions to correct it. This is the process of corrective. Next, further investigating the reasons and taking actions to prevent it happening again, which is the process of prevention.
5.参考文件Reference
5.1.FDA21 联邦法规211部FDA 21 CFR part 211
5.2.世卫组织药物制剂质量标准专家委员会报告（48）
WHO Expert Committee on Specifications for Pharmaceutical Preparations 48 report
5.3. 2014.03.01日药品检验合作计划PE 009-11 (第一部)
Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme PE 009-11 (Part-I) 01 March 2014
5.4.欧盟《人用及兽用良好生产规范》第四卷第一章药品质量体系（修订版3）
Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary U Chapter 1 Pharmaceutical Quality System Revision 3
6.内容Content
6.1.事件发生负责部门需应根据调查情况、偏差、自检、验证/确认、变更、质量风险管理、超出校准范围、超趋势以及客户投诉等发起CAPA且在执行过程中遵循《纠正和预防措施实施表》。有些情况，如法规审计发现项以及年度产品质量回顾，可能没有负责部门，则QA应根据《纠正和预防措施实施表》发起CAPA。
Responsible department in which the incident occurred shall initiate CAPA's bad on any Investigation, Deviation, Self-Inspection, Out of specification, Validation/ Qualification, Change Control, Quality Risk Management, Out of Calibration, Out of trend, Customer Complaints etc. following CAPA Implementation Form . In some cas where there is no responsible department, like Regulatory Audit Obrvation, APQR, QA shall rai the CAPA following CAPA Implementation Form .
6.2.负责部门（发起人）应在《纠正和预防措施实施表》中填写CAPA的来源、不符合情况描述、找出事件发生的根本原因以及需要采取的纠正预防措施。若CAPA来源为其他，且根本原因已找出，发起人只需从之前的调查报告将根本原因誊写下来即可。
Responsible department (Initiator) shall write down the source of CAPA, description of no-complianc
e and find out the root cau of the incident and also write down the action need to be taken (CAPA) in CAPA Implementation Form . If the CAPA generated from other sources where the root cau is already identified, initiator shall only write the root cau from that investigation report.
6.3.负责部门（发起人）应确定CAPA完成预计的时限以完成CAPA。与部门负责人协商后还需填写负责完成CAPA 人员的姓名及职位。
Responsible department (Initiator) shall decide the estimated timeline to complete the CAPA and write the name and designation of the responsible person who will complete the CAPA after consulting with the department head.
6.4.负责部门领导应对CAPA进行审核并批准。
Responsible department head shall review the CAPA and give approval.
6.5.负责部门（发起人）应将CAPA表格交至QA，由QA经理进行批准。
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Responsible department (Initiator) shall submit the CAPA form to QA for approval of QA Manager.
6.6.QA应按照以下规则给出CAPA编号。
QA shall give a CAPA reference number as per following manner against each action.
CAPA/XX-XXXX/ZZ/YYYY.
Where, CAPA = Abbreviation of Corrective action and Preventive action
此处，CAPA（Corrective and Preventive Action）为纠正与预防措施的缩写。
XX= Company name XX代表公司名称
XXXX = Abbreviation of Source of CAPA (Maximum four alphabet)
XXXX为CAPA来源的缩写（最多为四个字母）
ZZ = Last two digit of the current year (19 and so on) e.g. CAPA/XX-DEV/19/0001 ZZ为年度后两位（如19），如：CAPA/XX-DEV/19/0001
YYYY = Sequential rial 0001 or 0002 and so on
YYYY为流水号，即0001,0002以此类推。
6.7.CAPA登记及电子数据更新CAPA entry and Spread Sheet updating
6.7.1.QA应在《CAPA计划及追踪》（）中对每个CAPA进行登记并在此电子表格中填写相关信息。另外QA 应将每一个CAPA按其来源分别记录在不同的CAPA电子表格中以便后续追踪。
QA shall entry in XL spread sheet () for individual action with all relevant information. QA shall Record all of the CAPAs individually (Source wi) in different CAPA spread sheet for easy tracking.
6.7.2.QA应将此信息与相关部门分享并监督CAPA的执行。
QA shall share the information with all the relevant department in a regular manner and monitor the execution of CAPA.
6.7.3.收到新的CAPA后，QA应立即更新电子表格中的信息。
QA Shall update each CAPA spread sheet immediately after receiving a new CAPA.
6.8.措施完成及时限延长Completion of actions and Time line extension
6.8.1.负责人在预定时限内完成指定的措施。若措施未能在预定时限内完成，CAPA负责人以及部门负责人可延期并给出合理的理由。
狗肉炖什么好吃
Complete (responsible person) the assigned action within t timeline. If the action is not completed within the due time, the action owner and department head can extend time upon getting the written justification.
6.8.2.负责人应指定合理的预计时限以完成措施，部门负责人以及QA经理进行批准。应在预计时限截止日期之前进行延期。
冰片有毒吗Responsible person should t a new justified target timeline to complete the individual action and take approval from the responsible department head and QA manager. Time extension shall be taken before finishing previous estimated timeline.
6.8.3.若措施不再适合，负责部门应提供书面理由并获得QA经理的批准。
Responsible department shall provide justification in writing and ask QA manager for authorization if the action is no longer applicable.
6.8.4.QA应有合理的理由关闭CAPA. QA can clo the CAPA with the justification.
6.8.5.措施完成后，负责人员应将相关文件交至QA处以关闭CAPA。
Responsible person shall submit the relevant documents to QA after completion of action to clo the CAPA form.
6.8.6.QA经理应对文件进行审核并确认CAPA完成情况。
QA Manager shall review the documents and verify the completion of CAPA.
6.9.验证CAPA有效性的方法Methods for Verifying Effectiveness of CAPA
6.9.1.QA经理应从以下方法中确定其中一种方法来验证CAPA的有效性。
接谈
入伍体检标准QA manager shall determine the method from below mentioned approaches for verification of effectiveness of CAPA:
•趋势分析—若为人为错误、培训、环境监控偏离、清洁偏差以及检测错误等情况，趋势分析可以帮助确定是否纠正措施可有效纠正问题。按照已确定的时间表审核数据并确定采取了纠正措施后问题或偏差是否再次发生（或经常发生）。多数情况下，数据会说明是否已采取的措施有效或是否还需制定其他纠正措施。
•Trend analysis — In cas of human error, training, environmental monitoring excursions, cleaning
deviations, testing errors, etc., trend analysis can help you determine if the corrective action has remediated the issue. Review data over a predetermined timeframe and determine if the problem or
