召回管理
2023-03-10 16:53:38 2 举报AI智能生成
对药品GMP范畴内的召回管理，结合中国药品召回管理办法、中国GMP实施指南，欧盟GMP以及FDA cGMP等法规、指南的要求进行解读。
作者其他创作
大纲/内容
召回流程
召回流程示意图
召回决策
1.来源：偏差、OOS调查、投诉、药物不良反应等
2.召回决策应当基于对产品安全隐患的调查与评估，内容参照《药品召回管理办法》（局令第29号）第二章 第十二、十三条
3.召回决策应由企业高层管理者在相关领域专家支持下进行
2.召回决策应当基于对产品安全隐患的调查与评估，内容参照《药品召回管理办法》（局令第29号）第二章 第十二、十三条
3.召回决策应由企业高层管理者在相关领域专家支持下进行
成立召回任务小组
召回小组必要时可要求任何部门提供协助，召回小组职责参照人员与职责部分：
制定召回计划
召回计划应当确定各个步骤、相应的负责人和参与人，相应的职责，及完成的时限。
计划涵盖的内容（详见中国GMP指南3.5.3 C）：
1.技术准备
2.沟通准备
3.财务准备
4.法律准备
1.技术准备
2.沟通准备
3.财务准备
4.法律准备
对已经上报的召回计划进行变更时，应当立即通知药品监督管理部
启动召回
1.通过预先确定的沟通方式，在规定时限内通知客户召回相关产品，同时向所在地药品监督管理部门报告
2.召回过程中企业应对公司仍有库存的相关产品立即封存，隔离存放，均应有清晰醒目的标志。召回过程中应当注意做好相关记录，包括通知客户的记录，客户反馈的记录，召回产品到货记录，应召回和实际召回数量的平衡关系等。
2.召回过程中企业应对公司仍有库存的相关产品立即封存，隔离存放，均应有清晰醒目的标志。召回过程中应当注意做好相关记录，包括通知客户的记录，客户反馈的记录，召回产品到货记录，应召回和实际召回数量的平衡关系等。
召回产品的接收、处理
中国2010GMP 第303条 已召回的产品应当有标识，并单独、妥善贮存，等待最终处理决定
1.接收：记录应包括：客户的名称/地址，召回产品的品名，批号、数量、召回日期和召回原因，应召回和实际召回数量的平衡关系等
处理：隔离存放，并均应有清晰醒目的标志
2.处理：召回任务小组负责对召回产品的情况进行及时总结，对本次召回产品的质量是否受到影响进行评估，提出召回产品的具体处理方案，并报请召回决策小组批准。在大多数情况下，药品召回处理决定需要同时报告药品监督管理部门进行备案或批准。 根据批准的处理决定，尽快进行处理并进行详细记录。必须销毁的药品，要在药品监督管理部门的监督下销毁。
处理：隔离存放，并均应有清晰醒目的标志
2.处理：召回任务小组负责对召回产品的情况进行及时总结，对本次召回产品的质量是否受到影响进行评估，提出召回产品的具体处理方案，并报请召回决策小组批准。在大多数情况下，药品召回处理决定需要同时报告药品监督管理部门进行备案或批准。 根据批准的处理决定，尽快进行处理并进行详细记录。必须销毁的药品，要在药品监督管理部门的监督下销毁。
召回总结报告
1.总结报告包括售出产品及召回产品之间的数量平衡计算；如有差额，有合理的解释和/或必要的处理措施；
2.对召回活动、召回效果、召回产品的处理情况等做出评价，经召回决策小组批准后，向药品监督管理部门提交召回总结报告。
3.召回总结报告将作为公司管理评审的一项主要内容
2.对召回活动、召回效果、召回产品的处理情况等做出评价，经召回决策小组批准后，向药品监督管理部门提交召回总结报告。
3.召回总结报告将作为公司管理评审的一项主要内容
制定CAPA
1.根本原因分析
2.制定CAPA，接入CAPA系统追踪管理
3.制定CAPA可能在召回过程的任一阶段
2.制定CAPA，接入CAPA系统追踪管理
3.制定CAPA可能在召回过程的任一阶段
关闭召回
召回系统有效性评估
欧盟GMP
8.30 The effectiveness of the arrangements in place for recalls should be periodically evaluated to confirm that they remain robust and fit for use. Such evaluations should extend to both within office-hour situations as well as out-of-office hour situations and, when performing such evaluations, consideration should be given as to whether mock-recall actions should be performed. This evaluation should be documented and justified.
8.30 The effectiveness of the arrangements in place for recalls should be periodically evaluated to confirm that they remain robust and fit for use. Such evaluations should extend to both within office-hour situations as well as out-of-office hour situations and, when performing such evaluations, consideration should be given as to whether mock-recall actions should be performed. This evaluation should be documented and justified.
中国2010GMP
第305条 应当定期对产品召回系统的有效性进行评估
中国GMP指南
评估可以通过模拟召回的方式进行演练，演练的过程和结果应进行记录。用于评价产品召回系统有效性的模拟召回演练可采用相似的流程图，区别仅在于召回的启动原因以及与外界的沟通活动都是虚拟的
第305条 应当定期对产品召回系统的有效性进行评估
中国GMP指南
评估可以通过模拟召回的方式进行演练，演练的过程和结果应进行记录。用于评价产品召回系统有效性的模拟召回演练可采用相似的流程图，区别仅在于召回的启动原因以及与外界的沟通活动都是虚拟的
文件和记录
欧盟GMP
8.20 There should be established written procedures, ......in order to undertake any recall ......
8.29 The progress of the recall process should be recorded until closure and a final report issued, including a reconciliation between the delivered and recovered quantities of the concerned products/batches.
8.20 There should be established written procedures, ......in order to undertake any recall ......
8.29 The progress of the recall process should be recorded until closure and a final report issued, including a reconciliation between the delivered and recovered quantities of the concerned products/batches.
FDA cGMP
211.150 Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:
(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
211.180 (e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually,
211.150 Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:
(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
211.180 (e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually,
中国2010GMP
第183条 下述活动也应当有相应的操作规程，其过程和结果应当有记录：
......（十）药品召回
第298条 应当制定召回操作规程，确保召回工作的有效性
第302条 产品召回负责人应当能够迅速查阅到药品发运记录
第304条 召回的进展过程应当有记录，并有最终报告。产品发运数量、已召回数量以及数量平衡情况应当在报告中予以说明。
中国GMP指南
召回行动正式完成后，应当对所有相关的文件进行归档，并长期保存
第183条 下述活动也应当有相应的操作规程，其过程和结果应当有记录：
......（十）药品召回
第298条 应当制定召回操作规程，确保召回工作的有效性
第302条 产品召回负责人应当能够迅速查阅到药品发运记录
第304条 召回的进展过程应当有记录，并有最终报告。产品发运数量、已召回数量以及数量平衡情况应当在报告中予以说明。
中国GMP指南
召回行动正式完成后，应当对所有相关的文件进行归档，并长期保存
时限
召回启动时限
欧盟GMP
8.22 Recall operations should be capable of being initiated promptly and at any time. In certain cases recall operations may need to be initiated to protect public or animal health prior to establishing the root cause(s) and full extent of the quality defect.
8.22 Recall operations should be capable of being initiated promptly and at any time. In certain cases recall operations may need to be initiated to protect public or animal health prior to establishing the root cause(s) and full extent of the quality defect.
中国2010GMP
第300条 召回应当能够随时启动，并迅速实施
第300条 召回应当能够随时启动，并迅速实施
药品召回管理办法 第16条 药品生产企业在作出药品召回决定后，应当制定召回计划并组织实施：
一级召回在24h内
二级召回在48h内
三级召回在72h内
同时向所在地省、自治区、直辖市药品监督管理部门报告
一级召回在24h内
二级召回在48h内
三级召回在72h内
同时向所在地省、自治区、直辖市药品监督管理部门报告
报告监管部门时限
药品召回管理办法 第17条 召回启动后将评估报告和召回计划通知监管：
一级召回在1日内
二级召回在3日内
三级召回在7日内
药品召回管理办法 第21条 召回过程中将召回进展通知监管：
一级召回每日
二级召回每3日
三级召回每7日
一级召回在1日内
二级召回在3日内
三级召回在7日内
药品召回管理办法 第21条 召回过程中将召回进展通知监管：
一级召回每日
二级召回每3日
三级召回每7日
中国2010GMP
第301条 因产品存在安全隐患决定从市场召回的，应当立即向当地药品监督管理部门报告
第301条 因产品存在安全隐患决定从市场召回的，应当立即向当地药品监督管理部门报告
欧盟GMP
8.15 Quality defects should be reported in a timely manner by the manufacturer to the marketing authorisation holder/sponsor and all concerned Competent Authorities in cases where the quality defect may result in the recall of the product or in an abnormal restriction in the supply of the product.
8.22 Recall operations should be capable of being initiated promptly and at any time. In certain cases recall operations may need to be initiated to protect public or animal health prior to establishing the root cause(s) and full extent of the quality defect.
8.26 All concerned Competent Authorities should be informed in advance in cases where products are intended to be recalled. For very serious issues ......rapid risk-reducing actions (such as a product recall) may have to be taken in advance of notifying the Competent Authorities. Wherever possible, attempts should be made to agree these in advance of their execution with the concerned Competent Authorities
8.15 Quality defects should be reported in a timely manner by the manufacturer to the marketing authorisation holder/sponsor and all concerned Competent Authorities in cases where the quality defect may result in the recall of the product or in an abnormal restriction in the supply of the product.
8.22 Recall operations should be capable of being initiated promptly and at any time. In certain cases recall operations may need to be initiated to protect public or animal health prior to establishing the root cause(s) and full extent of the quality defect.
8.26 All concerned Competent Authorities should be informed in advance in cases where products are intended to be recalled. For very serious issues ......rapid risk-reducing actions (such as a product recall) may have to be taken in advance of notifying the Competent Authorities. Wherever possible, attempts should be made to agree these in advance of their execution with the concerned Competent Authorities
定义
NMPA 药品召回管理办法：
药品召回，是指药品上市许可持有人（以下称持有人）按照规定的程序收回已上市的存在质量问题或者其他安全隐患药品，并采取相应措施，及时控制风险、消除隐患的活动
药品召回，是指药品上市许可持有人（以下称持有人）按照规定的程序收回已上市的存在质量问题或者其他安全隐患药品，并采取相应措施，及时控制风险、消除隐患的活动
一般原则
中国2010GMP
第293条 企业应当建立产品召回系统，必要时可迅速、有效地从市场召回任何一批存在安全隐患的产品。
第294条 因质量原因退货和召回的产品，均应当按照规定监督销毁，有证据证明退货产品质量未受影响的除外。
第293条 企业应当建立产品召回系统，必要时可迅速、有效地从市场召回任何一批存在安全隐患的产品。
第294条 因质量原因退货和召回的产品，均应当按照规定监督销毁，有证据证明退货产品质量未受影响的除外。
欧盟GMP Chapter 8 principle
1....... a system and appropriate procedures should be in place to record, assess, investigate and review complaints including potential quality defects, and if necessary, to effectively and promptly recall medicinal products ......Quality Risk Management principles should be applied to...... product recalls .
2.All concerned competent authorities should be informed in a timely manner in case of ...... recall of the product ......
3.In case of outsourced activities,...... Such contracts should also address how to contact those responsible at each party for the management of quality defect and recall issues.
8.21 After a product has been placed on the market, any retrieval of it from the distribution network as a result of a quality defect should be regarded and managed as a recall.
8.24 In the case of investigational medicinal products, ....... The sponsor should implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall. The sponsor should ensure that the procedure discloses the identity of the blinded product only in so far as is necessary
1....... a system and appropriate procedures should be in place to record, assess, investigate and review complaints including potential quality defects, and if necessary, to effectively and promptly recall medicinal products ......Quality Risk Management principles should be applied to...... product recalls .
2.All concerned competent authorities should be informed in a timely manner in case of ...... recall of the product ......
3.In case of outsourced activities,...... Such contracts should also address how to contact those responsible at each party for the management of quality defect and recall issues.
8.21 After a product has been placed on the market, any retrieval of it from the distribution network as a result of a quality defect should be regarded and managed as a recall.
8.24 In the case of investigational medicinal products, ....... The sponsor should implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall. The sponsor should ensure that the procedure discloses the identity of the blinded product only in so far as is necessary
人员与职责
中国2010GMP
第25条 质量受权人（二）主要职责：
1.参与企业质量体系建立、内部自检、外部质量审计、验证以及药品不良反应报告、产品召回等质量管理活动
第299条 应当指定专人负责组织协调召回工作，并配备足够数量的人员。 产品召回负责人应当独立于销售和市场部门；如产品召回负责人不是质量受权人，则应当向质量受权人通报召回处理情况。
第302条 产品召回负责人应当能够迅速查阅到药品发运记录
第25条 质量受权人（二）主要职责：
1.参与企业质量体系建立、内部自检、外部质量审计、验证以及药品不良反应报告、产品召回等质量管理活动
第299条 应当指定专人负责组织协调召回工作，并配备足够数量的人员。 产品召回负责人应当独立于销售和市场部门；如产品召回负责人不是质量受权人，则应当向质量受权人通报召回处理情况。
第302条 产品召回负责人应当能够迅速查阅到药品发运记录
中国GMP实施指南
召回决策小组
召回决策小组
中国GMP实施指南
召回工作小组
召回工作小组
欧盟GMP
8.1 Appropriately trained and experienced personnel should be responsible for managing complaint and quality defect investigations and for deciding the measures to be taken to manage any potential risk(s) presented by those issues, including recalls. These persons should be independent of the sales and marketing organisation, unless otherwise justified. If these persons do not include the Qualified Person involved in the certification for release of the concerned batch or batches, the latter should be made formally aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner.
8.23 The batch/product distribution records should be readily available to the persons responsible for recalls, ......
8.1 Appropriately trained and experienced personnel should be responsible for managing complaint and quality defect investigations and for deciding the measures to be taken to manage any potential risk(s) presented by those issues, including recalls. These persons should be independent of the sales and marketing organisation, unless otherwise justified. If these persons do not include the Qualified Person involved in the certification for release of the concerned batch or batches, the latter should be made formally aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner.
8.23 The batch/product distribution records should be readily available to the persons responsible for recalls, ......
FDA cGMP 211.180 (f) :...... the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations ...... of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.
定义和分类
NMPA 药品召回管理办法：
根据召回活动发起主体的不同，药品召回分为主动召回和责令召回两类：
主动召回：持有人经调查评估后，确定药品存在质量问题或者其他安全隐患的，应当立即决定并实施召回，同时通过企业官方网站或者药品相关行业媒体向社会发布召回信息。
责令召回：有以下情形之一的，省、自治区、直辖市人民政府药品监督管理部门应当责令持有人召回药品：（一）药品监督管理部门经过调查评估，认为持有人应当召回药品而未召回的；（二）药品监督管理部门经对持有人主动召回结果审查，认为持有人召回药品不彻底的。
第十三条 根据药品质量问题或者其他安全隐患的严重程度，药品召回分为：
（一）一级召回：使用该药品可能或者已经引起严重健康危害的；
（二）二级召回：使用该药品可能或者已经引起暂时或者可逆的健康危害的；
（三）三级召回：使用该药品一般不会引起健康危害，但由于其他原因需要收回的。
根据召回活动发起主体的不同，药品召回分为主动召回和责令召回两类：
主动召回：持有人经调查评估后，确定药品存在质量问题或者其他安全隐患的，应当立即决定并实施召回，同时通过企业官方网站或者药品相关行业媒体向社会发布召回信息。
责令召回：有以下情形之一的，省、自治区、直辖市人民政府药品监督管理部门应当责令持有人召回药品：（一）药品监督管理部门经过调查评估，认为持有人应当召回药品而未召回的；（二）药品监督管理部门经对持有人主动召回结果审查，认为持有人召回药品不彻底的。
第十三条 根据药品质量问题或者其他安全隐患的严重程度，药品召回分为：
（一）一级召回：使用该药品可能或者已经引起严重健康危害的；
（二）二级召回：使用该药品可能或者已经引起暂时或者可逆的健康危害的；
（三）三级召回：使用该药品一般不会引起健康危害，但由于其他原因需要收回的。
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